Clinical trial NCT01141049: Gabapentin for Abstinence Initiation in Alcohol Dependence
Official title: Gabapentin for Abstinence Initiation in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alcohol Dependence
Keywords: Alcohol Withdrawal
Reducing Alcohol Consumption
Promoting abstinence in alcohol-dependent patients
Gabapentin
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In an 8-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of gabapentin in the treatment of alcohol dependence will be studied in 60 patients. Participants will be randomly assigned to treatment under double-blind conditions with either 1) a fixed dosing schedule of gabapentin or 2) placebo. All participants will receive weekly supportive behavioral treatment that promotes abstinence from alcohol and other substances, encourages mutual-support meeting attendance, and facilitates compliance with study medication. The primary outcome measures will be: the reduction of heavy drinking days per week as measured by the timeline follow-back method.

Participants will be alcohol-dependent men and nonpregnant women who report 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. The daily minimum drinking requirements are consistent with the commonly accepted definition of "binge drinking." A minimum requirement of having a heavy drinking episode 4 days a week would select for a population of individuals who are drinking excessively more days than not. A minimum threshold of weekly alcohol use is set to prevent a "floor effect" (i.e. participants with minimal alcohol use at baseline would be unable to demonstrate significant improvement.)

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.

Primary outcomes:
measure: Percent of Heavy Drinking Days Per Week
timeFrame: assesed over 8 weeks, presented for week 8 of trial
Secondary outcomes:
measure: Percent Days of Abstinence From Alcohol
timeFrame: assessed for up to 8 weeks, presented at week 8 of trial
Other outcomes:
Locations:
city: New York
country: United States
facility: Substance Treatment and Research Service (STARS)
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI
name: John Mariani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mariani JJ, Pavlicova M, Basaraba C, Mamczur-Fuller A, Brooks DJ, Bisaga A, Carpenter KM, Nunes EV, Levin FR. Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder. Alcohol Clin Exp Res. 2021 Aug;45(8):1639-1652. doi: 10.1111/acer.14648. Epub 2021 Jul 5.