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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

October 20, 2006
November 7, 2014
February 2004
July 2009   (final data collection date for primary outcome measure)
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).
  • Drinking frequency
  • Drinking quantity
Complete list of historical versions of study NCT00391716 on ClinicalTrials.gov Archive Site
  • 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.
  • Mood
  • Sleep
  • Craving
Not Provided
Not Provided
 
Gabapentin Treatment of Alcohol Dependence
Gabapentin Treatment of Alcohol Dependence

Gabapentin treatment for alcohol dependence

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcoholism
  • Alcohol Dependence
  • 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
  • Drug: placebo
    lactose capsule compounded to mimic gabapentin capsules
    Other Name: lactose capsule
  • Drug: gabapentin 1800mg
    1800 mg gabapentin daily for 12 weeks
    Other Name: Neurontin
  • Experimental: gabapentin 900mg daily
    900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
    Interventions:
    • Drug: Gabapentin 900mg
    • Behavioral: behavioral counseling
  • Experimental: gabapentin 1800mg daily
    1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
    Interventions:
    • Behavioral: behavioral counseling
    • Drug: gabapentin 1800mg
  • Placebo Comparator: placebo daily
    placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
    Interventions:
    • Behavioral: behavioral counseling
    • Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2010
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00391716
NIAAAMAS014028, R37AA014028
No
Barbara J. Mason, The Scripps Research Institute
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Barbara J. Mason, PhD The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
The Scripps Research Institute
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP