Trial Outcomes & Findings for Medication Development for Opioid and Alcohol Abuse (NCT NCT03205423)
NCT ID: NCT03205423
Last Updated: 2024-09-19
Results Overview
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Gabapentin (Active First)
Gabapentin maintenance once daily at 8am for 8 weeks (1800 mg \[(4 weeks) followed by 0 mg(4 weeks)\]. In this trial, gabapentin is investigated for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin (Placebo First)
Gabapentin maintenance once daily at 8am for 8 weeks (0 mg \[(4 weeks) followed by 1800 mg (4 weeks)\]. In this trial, gabapentin is investigated for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Gabapentin (Active First)
Gabapentin maintenance once daily at 8am for 8 weeks (1800 mg \[(4 weeks) followed by 0 mg(4 weeks)\]. In this trial, gabapentin is investigated for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin (Placebo First)
Gabapentin maintenance once daily at 8am for 8 weeks (0 mg \[(4 weeks) followed by 1800 mg (4 weeks)\]. In this trial, gabapentin is investigated for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Overall Study
Personal
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Medication Development for Opioid and Alcohol Abuse
Baseline characteristics by cohort
| Measure |
Gabapentin (Within-Subjects)
n=17 Participants
Participants are randomized to receive gabapentin once daily at 8am.
|
|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Placebo.
|
3.3 units on a scale
Standard Deviation .8
|
2.3 units on a scale
Standard Deviation .6
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.
|
3.0 units on a scale
Standard Deviation .6
|
9.1 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.
|
6.7 units on a scale
Standard Deviation 1.1
|
10.9 units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.
|
6.3 units on a scale
Standard Deviation .9
|
9.7 units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose.
|
3.7 units on a scale
Standard Deviation .6
|
8.0 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Low Alcohol Dose.
|
4.1 units on a scale
Standard Deviation .7
|
11.4 units on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to High Alcohol Dose.
|
4.8 units on a scale
Standard Deviation .9
|
8.6 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Oxycodone (30mg)
|
2.7 units on a scale
Standard Deviation .7
|
5.3 units on a scale
Standard Deviation .9
|
PRIMARY outcome
Timeframe: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.Population: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Outcome measures
| Measure |
Gabapentin 0 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
Gabapentin 1800 mg
n=13 Participants
once daily at 8am
Gabapentin: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
|
|---|---|---|
|
Peak Positive Subjective Responses to Oxycodone (15mg)
|
1.9 units on a scale
Standard Deviation .4
|
4.7 units on a scale
Standard Deviation .9
|
Adverse Events
Gabapentin (0 mg, i.e., Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gabapentin (1800 mg i.e., Active)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin (0 mg, i.e., Placebo)
n=17 participants at risk
Gabapentin maintenance (0 mg, i.e., placebo) once daily at 8 am for 4 weeks.
|
Gabapentin (1800 mg i.e., Active)
n=17 participants at risk
Gabapentin maintenance (1800 mg i.e., Active) once daily at 8 am for 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Elevated Blood Pressure
|
5.9%
1/17 • Number of events 1 • Throughout the 4-week inpatient period
|
5.9%
1/17 • Number of events 1 • Throughout the 4-week inpatient period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place