Trial Outcomes & Findings for Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone (NCT NCT00183196)
NCT ID: NCT00183196
Last Updated: 2018-06-07
Results Overview
Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-06-07
Participant Flow
Participant milestones
| Measure |
Naltrexone Plus Gabapentin and CBI
Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
|
Naltrexone Plus Placebo and CBI
Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
|
Placebo Plus Placebo Plus CBI
Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
30
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
20
|
15
|
18
|
Reasons for withdrawal
| Measure |
Naltrexone Plus Gabapentin and CBI
Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
|
Naltrexone Plus Placebo and CBI
Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
|
Placebo Plus Placebo Plus CBI
Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
11
|
13
|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Legal event
|
1
|
1
|
1
|
|
Overall Study
Required more intensive care
|
0
|
1
|
2
|
Baseline Characteristics
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Baseline characteristics by cohort
| Measure |
Naltrexone Plus Gabapentin and CBI
n=50 Participants
Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
|
Naltrexone Plus Placebo and CBI
n=50 Participants
Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
|
Placebo Plus Placebo Plus CBI
n=50 Participants
Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
|
Total
n=150 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
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
50 participants
n=5 Participants
|
150 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Subjects who entered the analysis were all people with any drinking data post randomization. There was 2 people in naltrexone plus gabapentin, 1 person in naltrexone alone and 1 person in placebo group that had no post-randomization drinking data and were therefore not included in the intent to treat analysis presented.
Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.
Outcome measures
| Measure |
Naltrexone Plus Gabapentin and CBI
n=48 Participants
Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
|
Naltrexone Plus Placebo and CBI
n=49 Participants
Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
|
Placebo Plus Placebo Plus CBI
n=49 Participants
Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
|
|---|---|---|---|
|
Time to Relapse to Drinking
|
69.9 days
Standard Error 6.5
|
59.6 days
Standard Error 7.6
|
57.3 days
Standard Error 6.7
|
Adverse Events
Naltrexone Plus Gabapentin and CBI
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Naltrexone Plus Placebo and CBI
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo Plus Placebo Plus CBI
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone Plus Gabapentin and CBI
n=50 participants at risk
Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
|
Naltrexone Plus Placebo and CBI
n=50 participants at risk
Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
|
Placebo Plus Placebo Plus CBI
n=50 participants at risk
Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
40.0%
20/50 • Number of events 33
|
22.0%
11/50 • Number of events 14
|
22.0%
11/50 • Number of events 21
|
|
General disorders
somnolence
|
78.0%
39/50 • Number of events 106
|
58.0%
29/50 • Number of events 81
|
62.0%
31/50 • Number of events 90
|
|
Eye disorders
Blurred vision
|
32.0%
16/50 • Number of events 41
|
26.0%
13/50 • Number of events 18
|
14.0%
7/50 • Number of events 25
|
|
Renal and urinary disorders
Premature ejaculation
|
28.2%
11/39 • Number of events 16
|
10.0%
4/40 • Number of events 4
|
20.0%
8/40 • Number of events 17
|
Additional Information
Raymond F. Anton, MD
Medical University of South Carolina
Phone: 843-792-1226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place