Trial Outcomes & Findings for Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals (NCT NCT01262092)
NCT ID: NCT01262092
Last Updated: 2013-06-21
Results Overview
urine data are from those obtained during the buprenorphine taper
COMPLETED
PHASE2
30 participants
3x weekly during wks 3 and 4
2013-06-21
Participant Flow
Thirty treatment-seeking opioid-dependent individuals were recruited from Central Arkansas by ads, word-of-mouth and referrals in October 2010 and January 2011-December of 2011. An experienced research staff member obtained informed consent interviewed subjects in a private office on the 4th floor of the Psychiatric Research Institute.
On Tuesday of Week 1, participants were randomized into treatment groups based on withdrawal symptoms score, sex and primary opioid of abuse using an urn randomization procedure. This was done to ensure that groups are balanced with respect to potential prognostic factors.
Participant milestones
| Measure |
Gabapentin
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
|
Placebo
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
|
|---|---|---|
|
Buprenorphine+Gabapentin/Plac Induction
STARTED
|
16
|
14
|
|
Buprenorphine+Gabapentin/Plac Induction
COMPLETED
|
13
|
13
|
|
Buprenorphine+Gabapentin/Plac Induction
NOT COMPLETED
|
3
|
1
|
|
Buprenorphine Taper
STARTED
|
12
|
13
|
|
Buprenorphine Taper
COMPLETED
|
11
|
12
|
|
Buprenorphine Taper
NOT COMPLETED
|
1
|
1
|
|
Gabapentin Taper
STARTED
|
10
|
11
|
|
Gabapentin Taper
COMPLETED
|
9
|
11
|
|
Gabapentin Taper
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Gabapentin
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
|
Placebo
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
|
|---|---|---|
|
Buprenorphine+Gabapentin/Plac Induction
Lost to Follow-up
|
2
|
1
|
|
Buprenorphine+Gabapentin/Plac Induction
Physician Decision
|
1
|
0
|
|
Buprenorphine Taper
noncompliance - missed medication
|
1
|
1
|
|
Gabapentin Taper
noncompliance - missed medications
|
1
|
0
|
Baseline Characteristics
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Baseline characteristics by cohort
| Measure |
Gabapentin
n=11 Participants
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
|
Placebo
n=13 Participants
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
|
Total
n=24 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
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 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
|
29.00 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
30.31 years
STANDARD_DEVIATION 10.62 • n=7 Participants
|
29.71 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3x weekly during wks 3 and 4Population: Those who started the bup detox (N=24) excluding 1 subjects' data in the gabapentin group due to evidence of noncompliance with medication procedures and diversion (N=1).
urine data are from those obtained during the buprenorphine taper
Outcome measures
| Measure |
Gabapentin
n=65 urine samples
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
|
Placebo
n=75 urine samples
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
|
|---|---|---|
|
Illicit Opioid Use as Determine by Urine Dipsticks
|
13.64 % of urines positive for opioids
Standard Error 5.69
|
32.56 % of urines positive for opioids
Standard Error 9.93
|
Adverse Events
Gabapentin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=16 participants at risk
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
|
Placebo
n=14 participants at risk
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
|
|---|---|---|
|
Nervous system disorders
Dizziness/Lightheadedness
|
6.2%
1/16 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
nausea/vomiting
|
25.0%
4/16 • Number of events 4
|
14.3%
2/14 • Number of events 3
|
|
Psychiatric disorders
Sleepiness/Fatigue/Somnulence
|
18.8%
3/16 • Number of events 3
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
Vivid, disturbing dreams, nightmares
|
25.0%
4/16 • Number of events 4
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
muscle twitches/cramps
|
25.0%
4/16 • Number of events 4
|
0.00%
0/14
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2
|
0.00%
0/14
|
Additional Information
Dr. Alison Oliveto
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place