Phase 3
N=40
Gabapentin for Abstinence Initiation in Alcohol Dependence
Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01141049 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Percent of Heavy Drinking Days Per Week — 22.5; 53.9 percent of heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gabapentin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Heavy Drinking Days Per Week |
22.5; 53.9 | — |
| SECONDARY Percent Days of Abstinence From Alcohol |
50; 27.5 | — |
Summary
Primary Hypotheses:
1. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method.
Secondary Hypotheses:
1. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.
Eligibility Criteria
Inclusion Criteria
- Between the ages of 18-65.
- Meets DSM-IV criteria for current alcohol dependence.
- Seeking treatment for alcohol dependence.
- Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days.
- Able to provide informed consent and comply with study procedures.
Exclusion Criteria
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.
- A diagnosis of current major depressive disorder or any other current Axis I psychiatric disorder as defined by DSM-IV-TR, other than alcohol dependence, that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
- Patients currently taking prescribed psychotropic medications that would be disrupted by study medication or by an effort to discontinue alcohol use.
- Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13.
- History of allergic reaction to candidate medication (gabapentin).
- History of alcohol withdrawal seizures or alcohol withdrawal delirium.
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men.
- Unstable medical conditions, such as poorly controlled diabetes or hypertension (> 140/90 mm Hg), which might make participation hazardous.
- Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine dependence. A diagnosis of substance abuse will not be exclusionary unless significant illicit substance use is present.
- Are legally mandated to participate in an alcohol use disorder treatment program.
- Who by history and current assessment represent a significant risk for suicide.
- Subjects who are likely, based on history, to place themselves in danger (e.g., driving while intoxicated or otherwise being unwilling to follow safety precautions).
- Renal insufficiency or abnormal renal function.
Data sourced from ClinicalTrials.gov (NCT01141049). 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.