Gabapentin Treatment of Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00391716
First received: October 20, 2006
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

Gabapentin treatment for alcohol dependence


Condition Intervention Phase
Alcoholism
Alcohol Dependence
Drug: Gabapentin 900mg
Behavioral: behavioral counseling
Drug: placebo
Drug: gabapentin 1800mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin Treatment of Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Drinking [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Mood [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    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.

  • Sleep [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    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.

  • Craving [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: February 2004
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gabapentin 900mg daily
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Drug: Gabapentin 900mg
900 mg gabapentin daily for 12 weeks
Other Name: Neurontin
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.
Other Name: alcoholfree.info
Experimental: gabapentin 1800mg daily
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling 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.
Other Name: alcoholfree.info
Drug: gabapentin 1800mg
1800 mg gabapentin daily for 12 weeks
Other Name: Neurontin
Placebo Comparator: placebo daily
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling 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.
Other Name: alcoholfree.info
Drug: placebo
lactose capsule compounded to mimic gabapentin capsules
Other Name: lactose capsule

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391716

Locations
United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
Investigators
Principal Investigator: Barbara J. Mason, PhD The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
  More Information

Additional Information:
Publications:
Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00391716     History of Changes
Other Study ID Numbers: NIAAAMAS014028, R37AA014028
Study First Received: October 20, 2006
Results First Received: June 9, 2014
Last Updated: November 7, 2014
Health Authority: United States: Federal Government

Keywords provided by The Scripps Research Institute:
Alcohol
Alcohol treatment
Alcoholism
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 04, 2015