Gabapentin Treatment of Alcohol Dependence

Alcoholism Clinical Trial

Official title:

Gabapentin Treatment of Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391716
• Other study ID #: NIAAAMAS014028
• Secondary ID: R37AA014028
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2006
• Last updated: November 7, 2014
• Start date: February 2004
• Est. completion date: February 2010

Study information

• Verified date: November 2014
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Gabapentin treatment for alcohol dependence

Description:

This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women over age 18 with alcohol dependence

Exclusion Criteria:

• Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances

• Significant medical disorders that will increase potential risk or interfere with study participation

• Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control

• Treatment with an investigational drug in the last month.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Gabapentin 900mg
900 mg gabapentin daily for 12 weeks

Behavioral:
• behavioral counseling
The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.

Drug:
• placebo
lactose capsule compounded to mimic gabapentin capsules
• gabapentin 1800mg
1800 mg gabapentin daily for 12 weeks

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinking	Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).	12-week	No
Secondary	Mood	Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.	12-week	No
Secondary	Sleep	The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.	12-week	No
Secondary	Craving	Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.	12-week	No

External Links

•   Link for JAMA Internal Medicine manuscript