Phase 2 Completed N=90 Randomized Quadruple-blind Treatment

Gabapentin for Alcohol Relapse Prevention

Alcohol Use Disorder · Alcohol Withdrawal

Source: ClinicalTrials.gov NCT02349477 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcomePrimary: Percent of Subjects With no Heavy Drinking Days (PSNHDD) — 12; 4 Participants — p=.028

Summary

This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Subjects With no Heavy Drinking Days (PSNHDD)	12; 4	.028 sig
SECONDARY Percent of Subjects With no Drinking Days (PSNDD)	8; 2	.053

Eligibility Criteria

Inclusion Criteria

Meets criteria for alcohol use disorder based on DSM-5 criteria
Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

Exclusion Criteria

Significant psychiatric or medical illness
No other substance abuse
Taking other medications known to treat alcohol use disorder
Unstable living arrangements
Significant legal problems pending

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02349477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.