Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2004-02-29
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Interventions
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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.
placebo
lactose capsule compounded to mimic gabapentin capsules
gabapentin 1800mg
1800 mg gabapentin daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
The Scripps Research Institute
OTHER
Responsible Party
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Barbara J. Mason
PI
Principal Investigators
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Barbara J. Mason, PhD
Role: PRINCIPAL_INVESTIGATOR
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
Locations
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The Scripps Research Institute
La Jolla, California, United States
Countries
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References
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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.
Other Identifiers
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NIAAAMAS014028
Identifier Type: -
Identifier Source: org_study_id