Trial Outcomes & Findings for Gabapentin for Alcohol Relapse Prevention (NCT NCT02349477)

Last Updated: 2019-11-04

Results Overview

The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

4 months

Results posted on

2019-11-04

Participant Flow

The discrepancy of 6 participants is due to those subjects either violating protocol or not having evaluable data.

Participant milestones

Participant milestones
Measure	Gabapentin Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	Placebo matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication
Overall Study STARTED	44	46
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	13	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gabapentin for Alcohol Relapse Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin n=44 Participants Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	Placebo n=46 Participants matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication	Total n=90 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 10.4 • n=5 Participants	48.9 years STANDARD_DEVIATION 9.9 • n=7 Participants	49.6 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
% Heavy Drinking Days	82.9 percent STANDARD_DEVIATION 23 • n=5 Participants	82.5 percent STANDARD_DEVIATION 21.6 • n=7 Participants	82.7 percent STANDARD_DEVIATION 22.2 • n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Gabapentin n=44 Participants Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	Placebo n=46 Participants matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication	High AWS/Gabapentin High on AWS median split variable, Gabapentin	High AWS/Placebo High on AWS median split variable, Placebo
Percent of Subjects With no Heavy Drinking Days (PSNHDD)	12 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: 4 months

The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT.

Outcome measures

Outcome measures
Measure	Gabapentin n=44 Participants Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	Placebo n=46 Participants matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication	High AWS/Gabapentin High on AWS median split variable, Gabapentin	High AWS/Placebo High on AWS median split variable, Placebo
Percent of Subjects With no Drinking Days (PSNDD)	8 Participants	2 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: The data for this analysis were split into two subgroups, based on the median split of AWS.

This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome).

Outcome measures

Outcome measures
Measure	Gabapentin n=22 Participants Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	Placebo n=23 Participants matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication	High AWS/Gabapentin n=22 Participants High on AWS median split variable, Gabapentin	High AWS/Placebo n=23 Participants High on AWS median split variable, Placebo
Number of Participants With No Drinking Days by AWS Score and Medication	2 Participants	3 Participants	10 Participants	1 Participants

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Michaela Hoffman

Medical University of South Carolina

Phone: 8437927758

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Gabapentin n=44 participants at risk Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	Placebo n=46 participants at risk matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication
Gastrointestinal disorders Abdominal Pain	22.7% 10/44 • Number of events 12 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	23.9% 11/46 • Number of events 16 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Decreased Appetite	27.3% 12/44 • Number of events 18 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	23.9% 11/46 • Number of events 13 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Decreased Libido	27.3% 12/44 • Number of events 24 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	10.9% 5/46 • Number of events 11 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Psychiatric disorders Depression	54.5% 24/44 • Number of events 80 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	47.8% 22/46 • Number of events 60 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Gastrointestinal disorders Diarrhea	52.3% 23/44 • Number of events 62 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	50.0% 23/46 • Number of events 42 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Nervous system disorders Dizziness	56.8% 25/44 • Number of events 60 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	32.6% 15/46 • Number of events 27 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Fatigue	68.2% 30/44 • Number of events 122 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	65.2% 30/46 • Number of events 108 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Nervous system disorders Headache	72.7% 32/44 • Number of events 129 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	73.9% 34/46 • Number of events 89 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Increased Appetite	52.3% 23/44 • Number of events 52 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	39.1% 18/46 • Number of events 32 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Increased Libido	15.9% 7/44 • Number of events 8 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	8.7% 4/46 • Number of events 6 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Insomnia	70.5% 31/44 • Number of events 92 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	71.7% 33/46 • Number of events 130 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Skin and subcutaneous tissue disorders Itching	22.7% 10/44 • Number of events 26 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	19.6% 9/46 • Number of events 21 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Gastrointestinal disorders Nausea	31.8% 14/44 • Number of events 26 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	39.1% 18/46 • Number of events 33 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Psychiatric disorders Nervousness/Anxiety	79.5% 35/44 • Number of events 172 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	69.6% 32/46 • Number of events 127 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Skin and subcutaneous tissue disorders Rash	15.9% 7/44 • Number of events 17 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	10.9% 5/46 • Number of events 7 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
General disorders Somnolence	13.6% 6/44 • Number of events 13 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	13.0% 6/46 • Number of events 7 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Psychiatric disorders Suicidal Ideation	9.1% 4/44 • Number of events 12 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	4.3% 2/46 • Number of events 2 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Gastrointestinal disorders Vomiting	20.5% 9/44 • Number of events 14 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.	13.0% 6/46 • Number of events 11 • Entire study - 16 weeks. Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.