Gabapentin for Abstinence Initiation in Alcohol Dependence

NCT ID: NCT01141049

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-12-31

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.)

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gabapentin

Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.

Placebo

Placebo capsules will be administered TID.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo, TID

Interventions

Gabapentin

During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.

Intervention Type: DRUG

Placebo

Placebo, TID

Intervention Type: OTHER

Other Intervention Names

Neurontin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

John Mariani MD

research psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Mariani, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

Substance Treatment and Research Service (STARS)

New York, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34120336 (View on PubMed)

Other Identifiers

#6123

Identifier Type: -

Identifier Source: org_study_id