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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
Results First Received: June 9, 2014  
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
Conditions: Alcoholism
Alcohol Dependence
Interventions: Drug: Gabapentin 900mg
Behavioral: behavioral counseling
Drug: placebo
Drug: gabapentin 1800mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gabapentin 900mg Daily

900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks

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.

Gabapentin 1800mg Daily

1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks

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.

gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks

Placebo Daily

placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

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.

placebo: lactose capsule compounded to mimic gabapentin capsules


Participant Flow:   Overall Study
    Gabapentin 900mg Daily     Gabapentin 1800mg Daily     Placebo Daily  
STARTED     54     47     49  
COMPLETED     27     28     30  
NOT COMPLETED     27     19     19  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sample size estimate was derived from results of a prior trial that found an odds ratio of 2.96 for complete abstinence, estimating a sample size of 150 would show a medium effect size for the difference between gabapentin and placebo in rate of complete abstinence.

Reporting Groups
  Description
Gabapentin 900mg Daily

900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks

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.

Gabapentin 1800mg Daily

1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks

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.

gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks

Placebo Daily

placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

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.

placebo: lactose capsule compounded to mimic gabapentin capsules

Total Total of all reporting groups

Baseline Measures
    Gabapentin 900mg Daily     Gabapentin 1800mg Daily     Placebo Daily     Total  
Number of Participants  
[units: participants]
  54     47     49     150  
Age  
[units: years]
Mean ± Standard Deviation
  41.9  ± 10.1     45.2  ± 11.3     46.8  ± 11.3     44.6  ± 10.9  
Gender  
[units: participants]
       
Female     21     16     28     65  
Male     33     31     21     85  
Meets Criteria for DSM-IV Alcohol Dependence [1]
[units: participants]
  54     47     49     150  
[1] Meets DSM-IV criteria for current Alcohol Dependence defined as three or more symptoms of dependence.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Drinking   [ Time Frame: 12-week ]

2.  Secondary:   Mood   [ Time Frame: 12-week ]

3.  Secondary:   Sleep   [ Time Frame: 12-week ]

4.  Secondary:   Craving   [ Time Frame: 12-week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Barbara J. Mason
Organization: The Scripps Research Institute
phone: 858-784-7324
e-mail: mason@scripps.edu


Publications of Results:

Responsible Party: Barbara J. Mason, 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