Trial Outcomes & Findings for Pharmacogenetics of Naltrexone for Stimulant Abuse (NCT NCT03226223)
NCT ID: NCT03226223
Last Updated: 2020-11-24
Results Overview
To assess the reinforcing effects of methamphetamine, participants complete a drug self-administration procedure. The outcome measure for this procedure is the number of operant responses (clicks on a mouse) participant are willing to make in order to receive drug (methamphetamine).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1 day.
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
Naltrexone 0mg First, Then Naltrexone 50mg
This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
Naltrexone 50mg First, Then Naltrexone 0mg
This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenetics of Naltrexone for Stimulant Abuse
Baseline characteristics by cohort
| Measure |
Naltrexone 0mg First, Then Naltrexone 50mg
n=8 Participants
This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
Naltrexone 50mg First, Then Naltrexone 0mg
n=6 Participants
This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 7.9 • 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
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day.To assess the reinforcing effects of methamphetamine, participants complete a drug self-administration procedure. The outcome measure for this procedure is the number of operant responses (clicks on a mouse) participant are willing to make in order to receive drug (methamphetamine).
Outcome measures
| Measure |
Naltrexone 0 mg
n=14 Participants
This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
Naltrexone 50 mg
n=14 Participants
This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
|---|---|---|
|
Methamphetamine Self-Administration
|
8890 Clicks on a computer mouse
Standard Deviation 3509
|
7116 Clicks on a computer mouse
Standard Deviation 3080
|
SECONDARY outcome
Timeframe: 1 dayParticipant ratings of methamphetamine "Liking," on a 100 mm visual analog scale. Participants are asked to indicate on a 100 mm line the extent to which they agree with the description of the drug provided. The 0 mm end of the line indicates "Not at All," while the 100 mm indicates "Extremely."
Outcome measures
| Measure |
Naltrexone 0 mg
n=14 Participants
This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
Naltrexone 50 mg
n=14 Participants
This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).
Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
|
|---|---|---|
|
Positive Subjective Effects of Methamphetamine.
|
53.6 units on a scale
Standard Deviation 38.9
|
57.2 units on a scale
Standard Deviation 32.5
|
Adverse Events
Naltrexone 0 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naltrexone 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place