Trial Outcomes & Findings for Gabapentin Treatment of Alcohol Dependence (NCT NCT00391716)
NCT ID: NCT00391716
Last Updated: 2014-11-10
Results Overview
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
12-week
Results posted on
2014-11-10
Participant Flow
Participant milestones
| Measure |
Gabapentin 900mg Daily
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
47
|
49
|
|
Overall Study
COMPLETED
|
27
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
27
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin Treatment of Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Gabapentin 900mg Daily
n=54 Participants
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 Participants
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 Participants
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Meets Criteria for DSM-IV Alcohol Dependence
|
54 participants
n=5 Participants
|
47 participants
n=7 Participants
|
49 participants
n=5 Participants
|
150 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12-weekPopulation: All randomized subjects included in denominator for rate determination.
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
Outcome measures
| Measure |
Gabapentin 900mg Daily
n=54 Participants
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 Participants
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 Participants
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Drinking
|
6 participants
|
8 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12-weekBeck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.
Outcome measures
| Measure |
Gabapentin 900mg Daily
n=54 Participants
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 Participants
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 Participants
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Mood
|
5.08 units on a scale
Standard Error .53
|
3.62 units on a scale
Standard Error .44
|
5.40 units on a scale
Standard Error .39
|
SECONDARY outcome
Timeframe: 12-weekThe Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.
Outcome measures
| Measure |
Gabapentin 900mg Daily
n=54 Participants
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 Participants
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 Participants
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Sleep
|
4.04 units on a scale
Standard Error .2
|
3.24 units on a scale
Standard Error .17
|
4.50 units on a scale
Standard Error .22
|
SECONDARY outcome
Timeframe: 12-weekAlcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.
Outcome measures
| Measure |
Gabapentin 900mg Daily
n=54 Participants
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 Participants
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 Participants
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Craving
|
33.66 units on a scale
Standard Error .78
|
32.31 units on a scale
Standard Error .82
|
34.27 units on a scale
Standard Error .70
|
Adverse Events
Gabapentin 900mg Daily
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Gabapentin 1800mg Daily
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Daily
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gabapentin 900mg Daily
n=54 participants at risk
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 participants at risk
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 participants at risk
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.9%
1/54 • 36 weeks
|
0.00%
0/47 • 36 weeks
|
0.00%
0/49 • 36 weeks
|
|
Investigations
Overnight Hospitalization
|
1.9%
1/54 • 36 weeks
|
0.00%
0/47 • 36 weeks
|
0.00%
0/49 • 36 weeks
|
Other adverse events
| Measure |
Gabapentin 900mg Daily
n=54 participants at risk
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
|
Gabapentin 1800mg Daily
n=47 participants at risk
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks
|
Placebo Daily
n=49 participants at risk
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules
|
|---|---|---|---|
|
Nervous system disorders
Fatigue
|
24.1%
13/54 • 36 weeks
|
19.1%
9/47 • 36 weeks
|
24.5%
12/49 • 36 weeks
|
|
Nervous system disorders
Headache
|
13.0%
7/54 • 36 weeks
|
12.8%
6/47 • 36 weeks
|
16.3%
8/49 • 36 weeks
|
|
Nervous system disorders
Insomnia
|
18.5%
10/54 • 36 weeks
|
12.8%
6/47 • 36 weeks
|
22.4%
11/49 • 36 weeks
|
|
Psychiatric disorders
Anxiety
|
3.7%
2/54 • 36 weeks
|
10.6%
5/47 • 36 weeks
|
12.2%
6/49 • 36 weeks
|
|
Eye disorders
Blurred Vision
|
3.7%
2/54 • 36 weeks
|
0.00%
0/47 • 36 weeks
|
10.2%
5/49 • 36 weeks
|
|
Psychiatric disorders
Depression
|
1.9%
1/54 • 36 weeks
|
6.4%
3/47 • 36 weeks
|
2.0%
1/49 • 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • 36 weeks
|
14.9%
7/47 • 36 weeks
|
6.1%
3/49 • 36 weeks
|
|
Metabolism and nutrition disorders
Increased hunger
|
5.6%
3/54 • 36 weeks
|
4.3%
2/47 • 36 weeks
|
0.00%
0/49 • 36 weeks
|
|
Nervous system disorders
Irritability
|
5.6%
3/54 • 36 weeks
|
8.5%
4/47 • 36 weeks
|
0.00%
0/49 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
1.9%
1/54 • 36 weeks
|
10.6%
5/47 • 36 weeks
|
4.1%
2/49 • 36 weeks
|
|
Nervous system disorders
Drowsy
|
1.9%
1/54 • 36 weeks
|
8.5%
4/47 • 36 weeks
|
8.2%
4/49 • 36 weeks
|
|
Nervous system disorders
Dry Mouth
|
5.6%
3/54 • 36 weeks
|
6.4%
3/47 • 36 weeks
|
2.0%
1/49 • 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place