Trial Outcomes & Findings for Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate) (NCT NCT03575403)
NCT ID: NCT03575403
Last Updated: 2025-04-10
Results Overview
The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Measured at each methylphenidate dose-level over approximately four weeks of participation.
Results posted on
2025-04-10
Participant Flow
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
Participant milestones
| Measure |
Placebo
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (30 MG)
Subjects received 30 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
2
|
6
|
|
Overall Study
0 mg Methylphenidate
|
11
|
2
|
6
|
|
Overall Study
20 mg Methylphenidate
|
10
|
2
|
6
|
|
Overall Study
40 mg Methylphenidate
|
10
|
2
|
6
|
|
Overall Study
60 mg Methylphenidate
|
9
|
2
|
6
|
|
Overall Study
COMPLETED
|
9
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (30 MG)
Subjects received 30 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
One subject left due to personal reasons unrelated to study-procedures
|
1
|
0
|
0
|
Baseline Characteristics
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (30 MG)
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Total
n=19 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
31.27 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
32.50 years
STANDARD_DEVIATION 13.44 • n=7 Participants
|
30.25 years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
30.48 years
STANDARD_DEVIATION 9.46 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Reinforcing Effects (Pre-Alcohol Dose Consumption)
Methylphenidate (0 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0043 to 0.0057
|
.01 Units on a Theoretical Scale
Interval 0.0078 to 0.012
|
0.007 Units on a Theoretical Scale
Interval 0.005 to 0.008
|
|
Reinforcing Effects (Pre-Alcohol Dose Consumption)
Methylphenidate (20 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0041 to 0.0058
|
.02 Units on a Theoretical Scale
Interval 0.014 to 0.02
|
0.007 Units on a Theoretical Scale
Interval 0.006 to 0.009
|
|
Reinforcing Effects (Pre-Alcohol Dose Consumption)
Methylphenidate (40 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0041 to 0.0057
|
0.014 Units on a Theoretical Scale
Interval 0.012 to 0.018
|
0.007 Units on a Theoretical Scale
Interval 0.006 to 0.008
|
|
Reinforcing Effects (Pre-Alcohol Dose Consumption)
Methylphenidate (60 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0041 to 0.0057
|
.02 Units on a Theoretical Scale
Interval 0.012 to 0.02
|
0.008 Units on a Theoretical Scale
Interval 0.006 to 0.009
|
PRIMARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Reinforcing Effects (Post-Alcohol Dose Consumption)
Methylphenidate (0 mg)
|
0.004 Units on a Theoretical Scale
Interval 0.0038 to 0.0052
|
.01 Units on a Theoretical Scale
Interval 0.0075 to 0.01
|
0.006 Units on a Theoretical Scale
Interval 0.005 to 0.008
|
|
Reinforcing Effects (Post-Alcohol Dose Consumption)
Methylphenidate (20 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0041 to 0.0054
|
.01 Units on a Theoretical Scale
Interval 0.01 to 0.013
|
0.007 Units on a Theoretical Scale
Interval 0.005 to 0.008
|
|
Reinforcing Effects (Post-Alcohol Dose Consumption)
Methylphenidate (40 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0039 to 0.0053
|
.014 Units on a Theoretical Scale
Interval 0.011 to 0.017
|
0.006 Units on a Theoretical Scale
Interval 0.005 to 0.008
|
|
Reinforcing Effects (Post-Alcohol Dose Consumption)
Methylphenidate (60 mg)
|
0.005 Units on a Theoretical Scale
Interval 0.0044 to 0.0056
|
.01 Units on a Theoretical Scale
Interval 0.01 to 0.016
|
0.009 Units on a Theoretical Scale
Interval 0.007 to 0.011
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Want Drink
|
17.22 units on a scale
Standard Deviation 17.48
|
7.50 units on a scale
Standard Deviation 0.71
|
23.50 units on a scale
Standard Deviation 20.42
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Feel Drink
|
15.89 units on a scale
Standard Deviation 15.45
|
4.50 units on a scale
Standard Deviation 2.12
|
22.00 units on a scale
Standard Deviation 17.34
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Feel High
|
0.11 units on a scale
Standard Deviation 0.33
|
1.00 units on a scale
Standard Deviation 1.41
|
2.00 units on a scale
Standard Deviation 3.95
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Like Drink
|
12.33 units on a scale
Standard Deviation 16.08
|
4.50 units on a scale
Standard Deviation 0.71
|
25.33 units on a scale
Standard Deviation 20.30
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Feel High
|
0.22 units on a scale
Standard Deviation 0.67
|
1.50 units on a scale
Standard Deviation 2.12
|
1.83 units on a scale
Standard Deviation 4.02
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Feel Drink
|
17.44 units on a scale
Standard Deviation 11.68
|
10.50 units on a scale
Standard Deviation 6.36
|
28.50 units on a scale
Standard Deviation 20.11
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Like Drink
|
16.78 units on a scale
Standard Deviation 23.55
|
9.50 units on a scale
Standard Deviation 6.36
|
27.33 units on a scale
Standard Deviation 22.14
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Want Drink
|
19.22 units on a scale
Standard Deviation 19.57
|
15.50 units on a scale
Standard Deviation 4.95
|
32.33 units on a scale
Standard Deviation 24.66
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Feel Drink
|
10.67 units on a scale
Standard Deviation 8.79
|
7.50 units on a scale
Standard Deviation 2.12
|
20.17 units on a scale
Standard Deviation 11.50
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Feel High
|
0.11 units on a scale
Standard Deviation 0.33
|
1.00 units on a scale
Standard Deviation 1.41
|
2.50 units on a scale
Standard Deviation 4.18
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Like Drink
|
16.89 units on a scale
Standard Deviation 21.97
|
10.00 units on a scale
Standard Deviation 1.41
|
24.00 units on a scale
Standard Deviation 18.28
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Want Drink
|
11.11 units on a scale
Standard Deviation 12.58
|
15.00 units on a scale
Standard Deviation 0.00
|
26.00 units on a scale
Standard Deviation 27.31
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Feel Drink
|
12.67 units on a scale
Standard Deviation 10.97
|
5.50 units on a scale
Standard Deviation 2.12
|
17.17 units on a scale
Standard Deviation 13.83
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Feel High
|
0.11 units on a scale
Standard Deviation 0.33
|
1.00 units on a scale
Standard Deviation 1.41
|
1.17 units on a scale
Standard Deviation 2.40
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Like Drink
|
10.78 units on a scale
Standard Deviation 12.77
|
8.00 units on a scale
Standard Deviation 0.00
|
20.50 units on a scale
Standard Deviation 21.14
|
|
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Want Drink
|
8.44 units on a scale
Standard Deviation 13.60
|
15.00 units on a scale
Standard Deviation 1.41
|
15.17 units on a scale
Standard Deviation 11.48
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Breath Alcohol Level
Methylphenidate (0 mg)
|
0.026 g/dl
Standard Deviation 0.014
|
0.031 g/dl
Standard Deviation 0.006
|
0.029 g/dl
Standard Deviation 0.013
|
|
Breath Alcohol Level
Methylphenidate (20 mg)
|
0.024 g/dl
Standard Deviation 0.006
|
0.031 g/dl
Standard Deviation 0.004
|
0.042 g/dl
Standard Deviation 0.030
|
|
Breath Alcohol Level
Methylphenidate (40 mg)
|
0.024 g/dl
Standard Deviation 0.008
|
0.041 g/dl
Standard Deviation 0.006
|
0.034 g/dl
Standard Deviation 0.021
|
|
Breath Alcohol Level
Methylphenidate (60 mg)
|
0.026 g/dl
Standard Deviation 0.007
|
0.023 g/dl
Standard Deviation 0.005
|
0.037 g/dl
Standard Deviation 0.015
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Systolic Blood Pressure
Methylphenidate (60 mg)
|
125.44 Millimeters of mercury
Standard Deviation 12.17
|
131.50 Millimeters of mercury
Standard Deviation 9.19
|
127.50 Millimeters of mercury
Standard Deviation 11.98
|
|
Systolic Blood Pressure
Methylphenidate (0 mg)
|
125.00 Millimeters of mercury
Standard Deviation 13.65
|
129.00 Millimeters of mercury
Standard Deviation 19.80
|
124.00 Millimeters of mercury
Standard Deviation 8.90
|
|
Systolic Blood Pressure
Methylphenidate (20 mg)
|
126.67 Millimeters of mercury
Standard Deviation 12.35
|
140.00 Millimeters of mercury
Standard Deviation 9.90
|
121.67 Millimeters of mercury
Standard Deviation 6.53
|
|
Systolic Blood Pressure
Methylphenidate (40 mg)
|
123.33 Millimeters of mercury
Standard Deviation 10.39
|
130.00 Millimeters of mercury
Standard Deviation 18.38
|
124.33 Millimeters of mercury
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Diastolic Blood Pressure
Methylphenidate (40 mg)
|
74.22 Millimeter of mercury
Standard Deviation 7.08
|
85.50 Millimeter of mercury
Standard Deviation 9.19
|
80.33 Millimeter of mercury
Standard Deviation 5.09
|
|
Diastolic Blood Pressure
Methylphenidate (60 mg)
|
74.00 Millimeter of mercury
Standard Deviation 8.89
|
82.00 Millimeter of mercury
Standard Deviation 8.49
|
80.50 Millimeter of mercury
Standard Deviation 9.14
|
|
Diastolic Blood Pressure
Methylphenidate (0 mg)
|
73.56 Millimeter of mercury
Standard Deviation 10.17
|
82.00 Millimeter of mercury
Standard Deviation 12.73
|
77.67 Millimeter of mercury
Standard Deviation 6.71
|
|
Diastolic Blood Pressure
Methylphenidate (20 mg)
|
74.00 Millimeter of mercury
Standard Deviation 9.49
|
88.50 Millimeter of mercury
Standard Deviation 6.36
|
77.00 Millimeter of mercury
Standard Deviation 8.51
|
SECONDARY outcome
Timeframe: Measured at each methylphenidate dose-level over approximately four weeks of participation.Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine 30 mg
n=2 Participants
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 Participants
Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Heart Rate
Methylphenidate (60 mg)
|
83.89 Beats per minute
Standard Deviation 13.04
|
80.50 Beats per minute
Standard Deviation 2.12
|
98.50 Beats per minute
Standard Deviation 21.72
|
|
Heart Rate
Methylphenidate (0 mg)
|
75.89 Beats per minute
Standard Deviation 11.47
|
66.50 Beats per minute
Standard Deviation 4.95
|
75.83 Beats per minute
Standard Deviation 11.41
|
|
Heart Rate
Methylphenidate (20 mg)
|
83.44 Beats per minute
Standard Deviation 12.63
|
80.50 Beats per minute
Standard Deviation 3.54
|
84.83 Beats per minute
Standard Deviation 11.43
|
|
Heart Rate
Methylphenidate (40 mg)
|
81.67 Beats per minute
Standard Deviation 7.48
|
73.50 Beats per minute
Standard Deviation 2.12
|
88.83 Beats per minute
Standard Deviation 13.01
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Duloxetine (30 MG)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Duloxetine (60 MG)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (30 MG)
n=2 participants at risk
Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.
|
Duloxetine (60 MG)
n=6 participants at risk
Subjects received 60 mg oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules.
|
|---|---|---|---|
|
Nervous system disorders
Agitation
|
27.3%
3/11 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Nervous system disorders
Anxiety
|
27.3%
3/11 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
3/6 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 4 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 5 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
33.3%
2/6 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Dry Mouth
|
45.5%
5/11 • Number of events 5 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
66.7%
4/6 • Number of events 4 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Ear and labyrinth disorders
Ear Congestion
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Change in Urination
|
27.3%
3/11 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Headache
|
36.4%
4/11 • Number of events 4 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
3/6 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Weakness
|
0.00%
0/11 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Loss of Voice
|
0.00%
0/11 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
33.3%
2/6 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Nausea
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
3/6 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Nervous system disorders
Nervousness
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Reproductive system and breast disorders
Changes in Sexual Function
|
0.00%
0/11 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Sleepiness/Dowsiness
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
33.3%
2/6 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Sore Throat
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Stuffy/Runny nose
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Sweating
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
3/6 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Weight Change
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Unusual Bruising/Bleeding
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Restlessness
|
27.3%
3/11 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
3/6 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Irritability
|
27.3%
3/11 • Number of events 3 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Decreased Appetite
|
36.4%
4/11 • Number of events 4 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
33.3%
2/6 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Increased Appetite
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
General disorders
Insomnia
|
18.2%
2/11 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
100.0%
2/2 • Number of events 2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
66.7%
4/6 • Number of events 4 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Cardiac disorders
Racing/Pounding Heart
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
16.7%
1/6 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Skin and subcutaneous tissue disorders
Itchness
|
9.1%
1/11 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/2 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/11 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
50.0%
1/2 • Number of events 1 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
0.00%
0/6 • Four weeks
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place