Trial Outcomes & Findings for Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine] (NCT NCT04178993)
NCT ID: NCT04178993
Last Updated: 2023-01-09
Results Overview
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
Results posted on
2023-01-09
Participant Flow
Participant milestones
| Measure |
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Baseline characteristics by cohort
| Measure |
Placebo Comparator: Placebo
n=4 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 Years
STANDARD_DEVIATION 13.08 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 13.11 • n=7 Participants
|
39.75 Years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 weekNumber of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
Methamphetamine (0mg)
|
0 Trials Completed
Standard Deviation 0
|
0 Trials Completed
Standard Deviation 0
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
Methamphetamine (10mg)
|
3.33 Trials Completed
Standard Deviation 5.77
|
7.25 Trials Completed
Standard Deviation 4.86
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
Methamphetamine (20mg)
|
10 Trials Completed
Standard Deviation 0
|
9.75 Trials Completed
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 weekNumber of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (0mg)
|
0 Trials Completed
Standard Deviation 0
|
2.50 Trials Completed
Standard Deviation 5.00
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (10mg)
|
6.67 Trials Completed
Standard Deviation 5.77
|
7.00 Trials Completed
Standard Deviation 4.69
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (20mg)
|
8.00 Trials Completed
Standard Deviation 3.46
|
9.75 Trials Completed
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 weekNumber of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (0mg)
|
1.67 Trials Completed
Standard Deviation 2.89
|
0 Trials Completed
Standard Deviation 0
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (10mg)
|
10 Trials Completed
Standard Deviation 0
|
5.00 Trials Completed
Standard Deviation 5.77
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (20mg)
|
10 Trials Completed
Standard Deviation 0
|
10 Trials Completed
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 weekNumber of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (0mg)
|
2.33 Trials Completed
Standard Deviation 4.04
|
0 Trials Completed
Standard Deviation 0
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (10mg)
|
3.33 Trials Completed
Standard Deviation 5.77
|
7.50 Trials Completed
Standard Deviation 5.00
|
|
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (20mg)
|
10 Trials Completed
Standard Deviation 0
|
9.75 Trials Completed
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (0 mg)
|
77.67 Beats Per Minute
Standard Deviation 16.17
|
78.00 Beats Per Minute
Standard Deviation 6.98
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (10 mg)
|
87.33 Beats Per Minute
Standard Deviation 15.14
|
77.25 Beats Per Minute
Standard Deviation 15.37
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (20 mg)
|
81.33 Beats Per Minute
Standard Deviation 12.01
|
83.75 Beats Per Minute
Standard Deviation 15.20
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (0 mg)
|
83.67 Beats Per Minute
Standard Deviation 2.06
|
76.00 Beats Per Minute
Standard Deviation 8.41
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (10 mg)
|
84.33 Beats Per Minute
Standard Deviation 8.50
|
78.50 Beats Per Minute
Standard Deviation 15.63
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (20 mg)
|
85.67 Beats Per Minute
Standard Deviation 8.74
|
89.50 Beats Per Minute
Standard Deviation 16.90
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (0 mg)
|
85.00 Beats Per Minute
Standard Deviation 13.08
|
91.25 Beats Per Minute
Standard Deviation 23.47
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (10 mg)
|
89.67 Beats Per Minute
Standard Deviation 10.21
|
87.75 Beats Per Minute
Standard Deviation 17.50
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (20 mg)
|
87.67 Beats Per Minute
Standard Deviation 12.86
|
87.00 Beats Per Minute
Standard Deviation 15.08
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (0 mg)
|
87.33 Beats Per Minute
Standard Deviation 15.28
|
88.00 Beats Per Minute
Standard Deviation 19.11
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (10 mg)
|
83.67 Beats Per Minute
Standard Deviation 11.72
|
87.50 Beats Per Minute
Standard Deviation 10.50
|
|
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (20 mg)
|
99.67 Beats Per Minute
Standard Deviation 10.69
|
88.00 Beats Per Minute
Standard Deviation 19.36
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (0 mg)
|
132.67 Millimeter of Mercury
Standard Deviation 2.89
|
128.75 Millimeter of Mercury
Standard Deviation 16.58
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (10 mg)
|
133.00 Millimeter of Mercury
Standard Deviation 13.45
|
131.00 Millimeter of Mercury
Standard Deviation 11.83
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (20 mg)
|
132.67 Millimeter of Mercury
Standard Deviation 5.03
|
144.25 Millimeter of Mercury
Standard Deviation 14.08
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (0 mg)
|
129.67 Millimeter of Mercury
Standard Deviation 2.31
|
124.25 Millimeter of Mercury
Standard Deviation 25.02
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (10 mg)
|
131.67 Millimeter of Mercury
Standard Deviation 18.61
|
128.00 Millimeter of Mercury
Standard Deviation 17.22
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (20 mg)
|
130.33 Millimeter of Mercury
Standard Deviation 13.20
|
132.75 Millimeter of Mercury
Standard Deviation 15.95
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (0 mg)
|
133.33 Millimeter of Mercury
Standard Deviation 2.08
|
129.75 Millimeter of Mercury
Standard Deviation 11.47
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (10 mg)
|
129.00 Millimeter of Mercury
Standard Deviation 12.77
|
132.25 Millimeter of Mercury
Standard Deviation 15.41
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (20 mg)
|
130.00 Millimeter of Mercury
Standard Deviation 10.44
|
139.25 Millimeter of Mercury
Standard Deviation 11.67
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (0 mg)
|
139.00 Millimeter of Mercury
Standard Deviation 4.00
|
127.00 Millimeter of Mercury
Standard Deviation 15.06
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (10 mg)
|
138.67 Millimeter of Mercury
Standard Deviation 11.59
|
129.75 Millimeter of Mercury
Standard Deviation 14.97
|
|
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (20 mg)
|
139.67 Millimeter of Mercury
Standard Deviation 3.06
|
135.25 Millimeter of Mercury
Standard Deviation 15.39
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (0 mg)
|
80.00 Millimeter of Mercury
Standard Deviation 3.00
|
78.50 Millimeter of Mercury
Standard Deviation 7.77
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (10 mg)
|
82.33 Millimeter of Mercury
Standard Deviation 0.58
|
83.75 Millimeter of Mercury
Standard Deviation 9.54
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (20 mg)
|
87.33 Millimeter of Mercury
Standard Deviation 5.51
|
86.25 Millimeter of Mercury
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (0 mg)
|
81.67 Millimeter of Mercury
Standard Deviation 4.51
|
74.50 Millimeter of Mercury
Standard Deviation 10.02
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (10 mg)
|
85.33 Millimeter of Mercury
Standard Deviation 8.50
|
83.25 Millimeter of Mercury
Standard Deviation 11.03
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (20 mg)
|
83.00 Millimeter of Mercury
Standard Deviation 3.61
|
85.00 Millimeter of Mercury
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (0 mg)
|
78.00 Millimeter of Mercury
Standard Deviation 2.65
|
81.00 Millimeter of Mercury
Standard Deviation 9.56
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (10 mg)
|
84.67 Millimeter of Mercury
Standard Deviation 5.51
|
82.25 Millimeter of Mercury
Standard Deviation 8.10
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (20 mg)
|
84.67 Millimeter of Mercury
Standard Deviation 6.51
|
85.00 Millimeter of Mercury
Standard Deviation 6.06
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (0 mg)
|
82.67 Millimeter of Mercury
Standard Deviation 5.51
|
82.25 Millimeter of Mercury
Standard Deviation 5.74
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (10 mg)
|
81.67 Millimeter of Mercury
Standard Deviation 8.08
|
82.25 Millimeter of Mercury
Standard Deviation 7.93
|
|
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (20 mg)
|
88.33 Millimeter of Mercury
Standard Deviation 4.73
|
84.25 Millimeter of Mercury
Standard Deviation 10.37
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (0 mg)
|
98.10 Degrees Fahrenheit
Standard Deviation 0.26
|
98.45 Degrees Fahrenheit
Standard Deviation 0.10
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (10 mg)
|
98.23 Degrees Fahrenheit
Standard Deviation 0.40
|
98.48 Degrees Fahrenheit
Standard Deviation 0.21
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Methamphetamine (20 mg)
|
98.40 Degrees Fahrenheit
Standard Deviation 0.36
|
98.48 Degrees Fahrenheit
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (0 mg)
|
98.37 Degrees Fahrenheit
Standard Deviation 0.23
|
98.50 Degrees Fahrenheit
Standard Deviation 0.08
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (10 mg)
|
98.10 Degrees Fahrenheit
Standard Deviation 0.36
|
98.75 Degrees Fahrenheit
Standard Deviation 0.26
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Methamphetamine (20 mg)
|
98.27 Degrees Fahrenheit
Standard Deviation 0.32
|
98.35 Degrees Fahrenheit
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (0 mg)
|
98.17 Degrees Fahrenheit
Standard Deviation 0.15
|
98.60 Degrees Fahrenheit
Standard Deviation 0.22
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (10 mg)
|
98.13 Degrees Fahrenheit
Standard Deviation 0.40
|
98.65 Degrees Fahrenheit
Standard Deviation 0.17
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Methamphetamine (20 mg)
|
98.43 Degrees Fahrenheit
Standard Deviation 0.15
|
98.55 Degrees Fahrenheit
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (0 mg)
|
98.37 Degrees Fahrenheit
Standard Deviation 0.35
|
98.65 Degrees Fahrenheit
Standard Deviation 0.17
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (10 mg)
|
98.43 Degrees Fahrenheit
Standard Deviation 0.15
|
98.65 Degrees Fahrenheit
Standard Deviation 0.06
|
|
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Methamphetamine (20 mg)
|
98.47 Degrees Fahrenheit
Standard Deviation 0.35
|
98.58 Degrees Fahrenheit
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
1.33 Millimeters
Standard Deviation 1.53
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Restless
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Nervous/Anxious
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Talkative/Friendly
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Irregular/Racing Heartbeat
|
1.33 Millimeters
Standard Deviation 2.31
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Euphoric
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Shaky/Jittery
|
1.33 Millimeters
Standard Deviation 2.31
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Active/Alert/Energetic
|
1.33 Millimeters
Standard Deviation 2.31
|
1.50 Millimeters
Standard Deviation 3.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Will Pay For
|
1.33 Millimeters
Standard Deviation 2.31
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Will Take Again
|
1.67 Millimeters
Standard Deviation 2.89
|
1.50 Millimeters
Standard Deviation 3.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Performance Improved
|
1.33 Millimeters
Standard Deviation 2.31
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Performance Impaired
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Stimulated
|
1.00 Millimeters
Standard Deviation 1.73
|
2.25 Millimeters
Standard Deviation 4.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Like Drug
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Rush
|
1.00 Millimeters
Standard Deviation 1.73
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
High
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Good Effects
|
1.33 Millimeters
Standard Deviation 2.31
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Bad Effects
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Any Effect
|
1.00 Millimeters
Standard Deviation 1.73
|
1.25 Millimeters
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
22.33 Millimeters
Standard Deviation 35.28
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Restless
|
1.00 Millimeters
Standard Deviation 1.73
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Nervous/Anxious
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
3.00 Millimeters
Standard Deviation 5.20
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Talkative/Friendly
|
4.33 Millimeters
Standard Deviation 6.66
|
12.50 Millimeters
Standard Deviation 23.04
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Irregular/Racing Heartbeat
|
0.33 Millimeters
Standard Deviation 0.58
|
2.25 Millimeters
Standard Deviation 4.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Euphoric
|
15.67 Millimeters
Standard Deviation 14.29
|
18.25 Millimeters
Standard Deviation 36.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Shaky/Jittery
|
1.00 Millimeters
Standard Deviation 1.73
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Active/Alert/Energetic
|
15.33 Millimeters
Standard Deviation 24.83
|
25.50 Millimeters
Standard Deviation 34.84
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Will Pay For
|
23.00 Millimeters
Standard Deviation 38.97
|
22.25 Millimeters
Standard Deviation 35.98
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Will Take Again
|
46.33 Millimeters
Standard Deviation 45.06
|
23.50 Millimeters
Standard Deviation 32.25
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Performance Improved
|
7.00 Millimeters
Standard Deviation 9.54
|
11.50 Millimeters
Standard Deviation 21.05
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Performance Impaired
|
11.33 Millimeters
Standard Deviation 19.63
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Stimulated
|
21.33 Millimeters
Standard Deviation 36.09
|
14.25 Millimeters
Standard Deviation 18.15
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Like Drug
|
33.67 Millimeters
Standard Deviation 57.45
|
15.00 Millimeters
Standard Deviation 15.10
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Rush
|
10.67 Millimeters
Standard Deviation 18.48
|
8.25 Millimeters
Standard Deviation 11.32
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
High
|
9.33 Millimeters
Standard Deviation 16.17
|
12.00 Millimeters
Standard Deviation 14.28
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Good Effects
|
12.67 Millimeters
Standard Deviation 20.21
|
13.75 Millimeters
Standard Deviation 15.95
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Bad Effects
|
2.67 Millimeters
Standard Deviation 4.62
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Any Effect
|
12.67 Millimeters
Standard Deviation 20.21
|
16.00 Millimeters
Standard Deviation 19.13
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
10.33 Millimeters
Standard Deviation 17.90
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Restless
|
0.67 Millimeters
Standard Deviation 1.15
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Nervous/Anxious
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
0.33 Millimeters
Standard Deviation 0.58
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Talkative/Friendly
|
20.00 Millimeters
Standard Deviation 32.05
|
13.75 Millimeters
Standard Deviation 26.84
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Irregular/Racing Heartbeat
|
1.00 Millimeters
Standard Deviation 1.73
|
4.25 Millimeters
Standard Deviation 7.23
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Euphoric
|
21.67 Millimeters
Standard Deviation 37.53
|
16.00 Millimeters
Standard Deviation 25.77
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Shaky/Jittery
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Active/Alert/Energetic
|
35.67 Millimeters
Standard Deviation 55.72
|
27.99 Millimeters
Standard Deviation 30.67
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Will Pay For
|
36.67 Millimeters
Standard Deviation 55.08
|
20.50 Millimeters
Standard Deviation 33.81
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Will Take Again
|
50.00 Millimeters
Standard Deviation 47.70
|
25.25 Millimeters
Standard Deviation 25.62
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Performance Improved
|
26.33 Millimeters
Standard Deviation 37.85
|
12.00 Millimeters
Standard Deviation 23.34
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Performance Impaired
|
32.67 Millimeters
Standard Deviation 56.58
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Stimulated
|
38.33 Millimeters
Standard Deviation 53.41
|
23.50 Millimeters
Standard Deviation 27.09
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Like Drug
|
37.67 Millimeters
Standard Deviation 54.00
|
26.25 Millimeters
Standard Deviation 27.56
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Rush
|
31.33 Millimeters
Standard Deviation 54.27
|
16.00 Millimeters
Standard Deviation 20.54
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
High
|
36.67 Millimeters
Standard Deviation 55.08
|
20.50 Millimeters
Standard Deviation 22.55
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Good Effects
|
30.33 Millimeters
Standard Deviation 44.77
|
23.00 Millimeters
Standard Deviation 23.17
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Bad Effects
|
23.67 Millimeters
Standard Deviation 40.99
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Any Effect
|
38.33 Millimeters
Standard Deviation 43.89
|
24.50 Millimeters
Standard Deviation 24.08
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
3.00 Millimeters
Standard Deviation 2.65
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Restless
|
1.33 Millimeters
Standard Deviation 2.31
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Nervous/Anxious
|
1.67 Millimeters
Standard Deviation 2.89
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
1.67 Millimeters
Standard Deviation 2.08
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Talkative/Friendly
|
4.00 Millimeters
Standard Deviation 6.93
|
0.75 Millimeters
Standard Deviation 1.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Irregular/Racing Heartbeat
|
1.67 Millimeters
Standard Deviation 2.89
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Euphoric
|
4.00 Millimeters
Standard Deviation 6.93
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Shaky/Jittery
|
3.00 Millimeters
Standard Deviation 5.20
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Active/Alert/Energetic
|
3.33 Millimeters
Standard Deviation 5.77
|
0.75 Millimeters
Standard Deviation 1.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Will Pay For
|
8.00 Millimeters
Standard Deviation 13.86
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Will Take Again
|
11.67 Millimeters
Standard Deviation 20.21
|
1.50 Millimeters
Standard Deviation 3.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Performance Improved
|
2.67 Millimeters
Standard Deviation 4.62
|
0.75 Millimeters
Standard Deviation 1.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Performance Impaired
|
2.33 Millimeters
Standard Deviation 4.04
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Stimulated
|
4.67 Millimeters
Standard Deviation 8.08
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Like Drug
|
7.67 Millimeters
Standard Deviation 13.28
|
1.50 Millimeters
Standard Deviation 3.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Rush
|
4.67 Millimeters
Standard Deviation 8.08
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
High
|
4.33 Millimeters
Standard Deviation 7.51
|
1.50 Millimeters
Standard Deviation 3.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Good Effects
|
4.00 Millimeters
Standard Deviation 6.93
|
1.50 Millimeters
Standard Deviation 3.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Bad Effects
|
2.67 Millimeters
Standard Deviation 4.62
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Any Effect
|
3.67 Millimeters
Standard Deviation 6.35
|
1.50 Millimeters
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
10.67 Millimeters
Standard Deviation 14.36
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Restless
|
2.00 Millimeters
Standard Deviation 3.46
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Nervous/Anxious
|
2.00 Millimeters
Standard Deviation 3.46
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
0.33 Millimeters
Standard Deviation 0.58
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Talkative/Friendly
|
14.67 Millimeters
Standard Deviation 23.69
|
13.75 Millimeters
Standard Deviation 26.18
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Irregular/Racing Heartbeat
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Euphoric
|
22.00 Millimeters
Standard Deviation 38.11
|
13.00 Millimeters
Standard Deviation 26.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Shaky/Jittery
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Active/Alert/Energetic
|
17.33 Millimeters
Standard Deviation 27.43
|
16.25 Millimeters
Standard Deviation 23.30
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Will Pay For
|
33.33 Millimeters
Standard Deviation 57.74
|
18.50 Millimeters
Standard Deviation 35.68
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Will Take Again
|
40.00 Millimeters
Standard Deviation 52.74
|
21.75 Millimeters
Standard Deviation 34.25
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Performance Improved
|
15.00 Millimeters
Standard Deviation 23.39
|
13.00 Millimeters
Standard Deviation 24.68
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Performance Impaired
|
5.67 Millimeters
Standard Deviation 9.81
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Stimulated
|
20.33 Millimeters
Standard Deviation 32.65
|
11.75 Millimeters
Standard Deviation 22.19
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Like Drug
|
35.33 Millimeters
Standard Deviation 56.01
|
14.00 Millimeters
Standard Deviation 24.06
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Rush
|
19.00 Millimeters
Standard Deviation 32.91
|
3.00 Millimeters
Standard Deviation 6.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
High
|
21.67 Millimeters
Standard Deviation 37.53
|
14.25 Millimeters
Standard Deviation 21.87
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Good Effects
|
21.00 Millimeters
Standard Deviation 30.35
|
9.75 Millimeters
Standard Deviation 15.59
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Bad Effects
|
6.33 Millimeters
Standard Deviation 10.12
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Any Effect
|
16.00 Millimeters
Standard Deviation 19.92
|
14.75 Millimeters
Standard Deviation 18.39
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
4.33 Millimeters
Standard Deviation 7.51
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Restless
|
9.33 Millimeters
Standard Deviation 16.17
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Nervous/Anxious
|
3.33 Millimeters
Standard Deviation 5.77
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
1.67 Millimeters
Standard Deviation 2.89
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Talkative/Friendly
|
22.67 Millimeters
Standard Deviation 37.54
|
14.50 Millimeters
Standard Deviation 27.01
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Irregular/Racing Heartbeat
|
3.00 Millimeters
Standard Deviation 5.20
|
3.50 Millimeters
Standard Deviation 5.20
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Euphoric
|
33.33 Millimeters
Standard Deviation 57.74
|
14.25 Millimeters
Standard Deviation 22.34
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Shaky/Jittery
|
1.33 Millimeters
Standard Deviation 2.31
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Active/Alert/Energetic
|
30.00 Millimeters
Standard Deviation 38.97
|
24.50 Millimeters
Standard Deviation 25.75
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Will Pay For
|
45.67 Millimeters
Standard Deviation 50.56
|
17.25 Millimeters
Standard Deviation 25.89
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Will Take Again
|
48.00 Millimeters
Standard Deviation 50.12
|
24.75 Millimeters
Standard Deviation 28.37
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Performance Improved
|
16.67 Millimeters
Standard Deviation 23.39
|
14.50 Millimeters
Standard Deviation 25.77
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Performance Impaired
|
11.33 Millimeters
Standard Deviation 19.63
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Stimulated
|
36.67 Millimeters
Standard Deviation 55.08
|
19.75 Millimeters
Standard Deviation 22.97
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Like Drug
|
47.33 Millimeters
Standard Deviation 50.21
|
18.75 Millimeters
Standard Deviation 23.85
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Rush
|
33.33 Millimeters
Standard Deviation 57.74
|
12.75 Millimeters
Standard Deviation 15.65
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
High
|
33.33 Millimeters
Standard Deviation 57.74
|
16.50 Millimeters
Standard Deviation 18.88
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Good Effects
|
35.67 Millimeters
Standard Deviation 55.73
|
14.25 Millimeters
Standard Deviation 12.45
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Bad Effects
|
6.33 Millimeters
Standard Deviation 10.12
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Any Effect
|
36.33 Millimeters
Standard Deviation 55.16
|
13.75 Millimeters
Standard Deviation 12.84
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Irregular/Racing Heartbeat
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Euphoric
|
7.00 Millimeters
Standard Deviation 12.12
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Shaky/Jittery
|
0.67 Millimeters
Standard Deviation 1.15
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Active/Alert/Energetic
|
10.33 Millimeters
Standard Deviation 17.90
|
0.50 Millimeters
Standard Deviation 0.58
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Nervous/Anxious
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Talkative/Friendly
|
8.00 Millimeters
Standard Deviation 13.86
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Restless
|
0.00 Millimeters
Standard Deviation 0.00
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Will Pay For
|
17.33 Millimeters
Standard Deviation 30.02
|
0.75 Millimeters
Standard Deviation 1.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Will Take Again
|
23.00 Millimeters
Standard Deviation 39.84
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Performance Improved
|
6.67 Millimeters
Standard Deviation 11.55
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Performance Impaired
|
7.67 Millimeters
Standard Deviation 13.28
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Stimulated
|
17.33 Millimeters
Standard Deviation 30.02
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Like Drug
|
16.33 Millimeters
Standard Deviation 28.29
|
1.25 Millimeters
Standard Deviation 2.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Rush
|
8.00 Millimeters
Standard Deviation 13.86
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
High
|
10.67 Millimeters
Standard Deviation 18.48
|
1.25 Millimeters
Standard Deviation 2.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Good Effects
|
8.33 Millimeters
Standard Deviation 14.43
|
1.25 Millimeters
Standard Deviation 2.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Bad Effects
|
6.33 Millimeters
Standard Deviation 10.97
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Any Effect
|
7.00 Millimeters
Standard Deviation 12.12
|
4.25 Millimeters
Standard Deviation 5.68
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
8.67 Millimeters
Standard Deviation 15.01
|
5.50 Millimeters
Standard Deviation 11.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Restless
|
5.33 Millimeters
Standard Deviation 9.24
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Nervous/Anxious
|
3.00 Millimeters
Standard Deviation 5.20
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
2.00 Millimeters
Standard Deviation 3.46
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Talkative/Friendly
|
18.67 Millimeters
Standard Deviation 32.33
|
13.75 Millimeters
Standard Deviation 24.86
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Irregular/Racing Heartbeat
|
2.00 Millimeters
Standard Deviation 2.65
|
1.25 Millimeters
Standard Deviation 2.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Euphoric
|
30.00 Millimeters
Standard Deviation 51.96
|
9.75 Millimeters
Standard Deviation 19.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Shaky/Jittery
|
6.33 Millimeters
Standard Deviation 10.12
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Active/Alert/Energetic
|
22.33 Millimeters
Standard Deviation 37.82
|
20.25 Millimeters
Standard Deviation 26.56
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Will Pay For
|
33.00 Millimeters
Standard Deviation 54.58
|
17.00 Millimeters
Standard Deviation 28.77
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Will Take Again
|
39.33 Millimeters
Standard Deviation 51.60
|
17.25 Millimeters
Standard Deviation 28.04
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Performance Improved
|
20.00 Millimeters
Standard Deviation 33.78
|
11.25 Millimeters
Standard Deviation 20.55
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Performance Impaired
|
6.00 Millimeters
Standard Deviation 10.39
|
2.25 Millimeters
Standard Deviation 4.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Stimulated
|
31.33 Millimeters
Standard Deviation 51.69
|
9.50 Millimeters
Standard Deviation 16.38
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Like Drug
|
33.67 Millimeters
Standard Deviation 54.00
|
15.00 Millimeters
Standard Deviation 24.18
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Rush
|
30.00 Millimeters
Standard Deviation 51.96
|
4.50 Millimeters
Standard Deviation 8.35
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
High
|
30.33 Millimeters
Standard Deviation 51.68
|
10.25 Millimeters
Standard Deviation 15.48
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Good Effects
|
31.33 Millimeters
Standard Deviation 51.68
|
9.25 Millimeters
Standard Deviation 13.52
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Bad Effects
|
3.67 Millimeters
Standard Deviation 6.35
|
2.50 Millimeters
Standard Deviation 4.36
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Any Effect
|
30.33 Millimeters
Standard Deviation 49.94
|
11.50 Millimeters
Standard Deviation 12.12
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
1.33 Millimeters
Standard Deviation 2.31
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Restless
|
0.33 Millimeters
Standard Deviation 0.58
|
1.25 Millimeters
Standard Deviation 2.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Nervous/Anxious
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Talkative/Friendly
|
25.33 Millimeters
Standard Deviation 39.55
|
15.50 Millimeters
Standard Deviation 27.01
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Irregular/Racing Heartbeat
|
2.33 Millimeters
Standard Deviation 4.04
|
0.75 Millimeters
Standard Deviation 1.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Euphoric
|
33.00 Millimeters
Standard Deviation 54.58
|
14.75 Millimeters
Standard Deviation 29.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Shaky/Jittery
|
7.00 Millimeters
Standard Deviation 12.12
|
1.25 Millimeters
Standard Deviation 2.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Active/Alert/Energetic
|
28.00 Millimeters
Standard Deviation 41.68
|
24.75 Millimeters
Standard Deviation 27.22
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Will Pay For
|
38.00 Millimeters
Standard Deviation 54.15
|
21.25 Millimeters
Standard Deviation 27.71
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Will Take Again
|
41.67 Millimeters
Standard Deviation 51.81
|
23.75 Millimeters
Standard Deviation 26.74
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Performance Improved
|
12.33 Millimeters
Standard Deviation 20.50
|
15.00 Millimeters
Standard Deviation 26.77
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Performance Impaired
|
5.33 Millimeters
Standard Deviation 9.24
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Stimulated
|
31.67 Millimeters
Standard Deviation 48.85
|
23.25 Millimeters
Standard Deviation 26.89
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Like Drug
|
34.33 Millimeters
Standard Deviation 49.33
|
24.75 Millimeters
Standard Deviation 26.29
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Rush
|
29.00 Millimeters
Standard Deviation 49.37
|
6.75 Millimeters
Standard Deviation 11.59
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
High
|
28.00 Millimeters
Standard Deviation 47.63
|
20.50 Millimeters
Standard Deviation 22.22
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Good Effects
|
35.00 Millimeters
Standard Deviation 48.545
|
22.75 Millimeters
Standard Deviation 22.01
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Bad Effects
|
12.00 Millimeters
Standard Deviation 10.82
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Any Effect
|
33.67 Millimeters
Standard Deviation 49.66
|
19.50 Millimeters
Standard Deviation 20.24
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Restless
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Nervous/Anxious
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Talkative/Friendly
|
12.33 Millimeters
Standard Deviation 21.36
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Irregular/Racing Heartbeat
|
0.00 Millimeters
Standard Deviation 0.00
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Euphoric
|
15.33 Millimeters
Standard Deviation 26.56
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Shaky/Jittery
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Active/Alert/Energetic
|
14.00 Millimeters
Standard Deviation 24.25
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Will Pay For
|
32.33 Millimeters
Standard Deviation 50.06
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Will Take Again
|
31.00 Millimeters
Standard Deviation 48.59
|
3.00 Millimeters
Standard Deviation 4.24
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Performance Improved
|
9.00 Millimeters
Standard Deviation 15.59
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Performance Impaired
|
14.33 Millimeters
Standard Deviation 24.83
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Stimulated
|
24.00 Millimeters
Standard Deviation 41.57
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Like Drug
|
29.67 Millimeters
Standard Deviation 47.96
|
0.50 Millimeters
Standard Deviation 1.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Rush
|
13.33 Millimeters
Standard Deviation 23.09
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
High
|
12.00 Millimeters
Standard Deviation 20.78
|
2.00 Millimeters
Standard Deviation 2.45
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Good Effects
|
13.67 Millimeters
Standard Deviation 23.67
|
0.75 Millimeters
Standard Deviation 1.50
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Bad Effects
|
3.00 Millimeters
Standard Deviation 5.20
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Any Effect
|
15.33 Millimeters
Standard Deviation 26.56
|
3.50 Millimeters
Standard Deviation 5.74
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Restless
|
5.00 Millimeters
Standard Deviation 6.24
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Nervous/Anxious
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
4.67 Millimeters
Standard Deviation 8.08
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Talkative/Friendly
|
29.00 Millimeters
Standard Deviation 50.23
|
11.00 Millimeters
Standard Deviation 18.74
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Irregular/Racing Heartbeat
|
0.00 Millimeters
Standard Deviation 0.00
|
3.75 Millimeters
Standard Deviation 3.77
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Euphoric
|
28.33 Millimeters
Standard Deviation 49.07
|
11.75 Millimeters
Standard Deviation 16.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Shaky/Jittery
|
3.67 Millimeters
Standard Deviation 6.35
|
2.00 Millimeters
Standard Deviation 4.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Active/Alert/Energetic
|
25.00 Millimeters
Standard Deviation 43.30
|
23.00 Millimeters
Standard Deviation 23.17
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Will Pay For
|
36.00 Millimeters
Standard Deviation 54.74
|
18.00 Millimeters
Standard Deviation 23.19
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Will Take Again
|
33.33 Millimeters
Standard Deviation 57.74
|
23.75 Millimeters
Standard Deviation 23.89
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Performance Improved
|
14.67 Millimeters
Standard Deviation 25.40
|
9.50 Millimeters
Standard Deviation 16.44
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Performance Impaired
|
5.33 Millimeters
Standard Deviation 9.24
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Stimulated
|
33.00 Millimeters
Standard Deviation 52.83
|
17.25 Millimeters
Standard Deviation 18.19
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Like Drug
|
32.67 Millimeters
Standard Deviation 55.72
|
23.75 Millimeters
Standard Deviation 23.30
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Rush
|
27.33 Millimeters
Standard Deviation 47.34
|
10.75 Millimeters
Standard Deviation 21.50
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
High
|
27.00 Millimeters
Standard Deviation 46.77
|
15.75 Millimeters
Standard Deviation 16.58
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Good Effects
|
25.33 Millimeters
Standard Deviation 43.88
|
20.25 Millimeters
Standard Deviation 18.37
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Bad Effects
|
4.67 Millimeters
Standard Deviation 8.08
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Any Effect
|
24.67 Millimeters
Standard Deviation 41.86
|
20.75 Millimeters
Standard Deviation 18.39
|
SECONDARY outcome
Timeframe: Daily over approximately 1 week of inpatient stay.Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Good Effects
|
39.00 Millimeters
Standard Deviation 53.23
|
20.25 Millimeters
Standard Deviation 27.93
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Sluggish/Fatigued/Lazy
|
6.67 Millimeters
Standard Deviation 11.55
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Restless
|
0.00 Millimeters
Standard Deviation 0.00
|
1.25 Millimeters
Standard Deviation 1.89
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Nervous/Anxious
|
0.33 Millimeters
Standard Deviation 0.58
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Nauseated/Queasy/Sick to Stomach
|
0.00 Millimeters
Standard Deviation 0.00
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Talkative/Friendly
|
29.33 Millimeters
Standard Deviation 50.23
|
18.25 Millimeters
Standard Deviation 31.94
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Irregular/Racing Heartbeat
|
30.67 Millimeters
Standard Deviation 53.12
|
1.00 Millimeters
Standard Deviation 2.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Euphoric
|
32.33 Millimeters
Standard Deviation 56.00
|
18.00 Millimeters
Standard Deviation 35.34
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Shaky/Jittery
|
2.00 Millimeters
Standard Deviation 3.46
|
0.25 Millimeters
Standard Deviation 0.50
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Active/Alert/Energetic
|
37.33 Millimeters
Standard Deviation 53.46
|
21.50 Millimeters
Standard Deviation 29.92
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Will Pay For
|
34.00 Millimeters
Standard Deviation 57.17
|
18.75 Millimeters
Standard Deviation 32.31
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Will Take Again
|
37.67 Millimeters
Standard Deviation 54.04
|
21.50 Millimeters
Standard Deviation 30.49
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Performance Improved
|
22.00 Millimeters
Standard Deviation 33.05
|
18.75 Millimeters
Standard Deviation 33.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Performance Impaired
|
10.33 Millimeters
Standard Deviation 17.90
|
13.50 Millimeters
Standard Deviation 27.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Stimulated
|
36.00 Millimeters
Standard Deviation 53.73
|
20.25 Millimeters
Standard Deviation 32.57
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Like Drug
|
36.33 Millimeters
Standard Deviation 54.31
|
21.50 Millimeters
Standard Deviation 31.72
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Rush
|
35.67 Millimeters
Standard Deviation 53.35
|
2.50 Millimeters
Standard Deviation 5.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
High
|
37.00 Millimeters
Standard Deviation 54.03
|
20.25 Millimeters
Standard Deviation 27.89
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Bad Effects
|
9.67 Millimeters
Standard Deviation 16.74
|
0.00 Millimeters
Standard Deviation 0.00
|
|
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Any Effect
|
38.00 Millimeters
Standard Deviation 53.11
|
19.25 Millimeters
Standard Deviation 24.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 sessions over approximately 4.5 weeksSubjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to "no-go" targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Attentional Bias
Methylphenidate (0mg)
|
0.07 Proportion of Responses
Standard Deviation 0.08
|
0.08 Proportion of Responses
Standard Deviation 0.07
|
|
Attentional Bias
Methylphenidate (20mg)
|
0.04 Proportion of Responses
Standard Deviation 0.04
|
0.13 Proportion of Responses
Standard Deviation 0.09
|
|
Attentional Bias
Methylphenidate (40mg)
|
0.08 Proportion of Responses
Standard Deviation 0.04
|
0.11 Proportion of Responses
Standard Deviation 0.05
|
|
Attentional Bias
Methylphenidate (60mg)
|
0.12 Proportion of Responses
Standard Deviation 0.11
|
0.12 Proportion of Responses
Standard Deviation 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 times over approximately 4.5 weeksA 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
Methylphenidate (60 mg)
|
44.67 Units on a Scale
Standard Deviation 5.88
|
53.00 Units on a Scale
Standard Deviation 6.00
|
|
Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
Methylphenidate (0 mg)
|
44.33 Units on a Scale
Standard Deviation 8.33
|
51.25 Units on a Scale
Standard Deviation 6.60
|
|
Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
Methylphenidate (20 mg)
|
44.00 Units on a Scale
Standard Deviation 3.46
|
52.75 Units on a Scale
Standard Deviation 4.72
|
|
Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
Methylphenidate (40 mg)
|
44.33 Units on a Scale
Standard Deviation 5.51
|
54.00 Units on a Scale
Standard Deviation 2.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 sessions over approximately 4.5 weeksSubjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered "now" or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \[e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Delay Discounting for Methamphetamine
Methylphenidate (0mg)
|
-1.40 log(k)
Standard Deviation 1.63
|
-1.31 log(k)
Standard Deviation 0.72
|
|
Delay Discounting for Methamphetamine
Methylphenidate (20mg)
|
-1.04 log(k)
Standard Deviation 1.10
|
-1.27 log(k)
Standard Deviation 0.49
|
|
Delay Discounting for Methamphetamine
Methylphenidate (40mg)
|
-1.45 log(k)
Standard Deviation 1.63
|
-1.15 log(k)
Standard Deviation 0.33
|
|
Delay Discounting for Methamphetamine
Methylphenidate (60mg)
|
-1.17 log(k)
Standard Deviation 1.91
|
-1.04 log(k)
Standard Deviation 0.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 sessions over approximately 4.5 weeksSubjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered "now" or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \[e.g., smaller sum of money given now as opposed to a larger sum given later\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=3 Participants
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 Participants
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Delay Discounting for Money
Methylphenidate (0mg)
|
-1.40 log(k)
Standard Deviation 1.63
|
-1.29 log(k)
Standard Deviation 0.76
|
|
Delay Discounting for Money
Methylphenidate (20mg)
|
-1.40 log(k)
Standard Deviation 1.63
|
-1.37 log(k)
Standard Deviation 0.58
|
|
Delay Discounting for Money
Methylphenidate (40mg)
|
-1.45 log(k)
Standard Deviation 1.63
|
-1.15 log(k)
Standard Deviation 0.33
|
|
Delay Discounting for Money
Methylphenidate (60mg)
|
-1.48 log(k)
Standard Deviation 1.43
|
-1.04 log(k)
Standard Deviation 0.43
|
Adverse Events
Placebo Comparator: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Comparator: Duloxetine (60 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Comparator: Placebo
n=3 participants at risk
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
|
Active Comparator: Duloxetine (60 mg)
n=4 participants at risk
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Methamphetamine: In each arm, subjects will receive doses of methamphetamine.
Methylphenidate: In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsule: In each arm, subjects will receive placebo capsules.
Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.
|
|---|---|---|
|
Cardiac disorders
Elevated Heart Rate
|
66.7%
2/3 • Number of events 2 • Assessed during 4.5 weeks of inpatient study.
|
50.0%
2/4 • Number of events 2 • Assessed during 4.5 weeks of inpatient study.
|
|
Cardiac disorders
Elevated Blood Pressure
|
66.7%
2/3 • Number of events 2 • Assessed during 4.5 weeks of inpatient study.
|
50.0%
2/4 • Number of events 2 • Assessed during 4.5 weeks of inpatient study.
|
|
Vascular disorders
Migraine
|
33.3%
1/3 • Number of events 1 • Assessed during 4.5 weeks of inpatient study.
|
0.00%
0/4 • Assessed during 4.5 weeks of inpatient study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place