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Sponsored by: |
The University of North Carolina, Chapel Hill |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00877734 |
This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid) baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB) method will be used to assess drinking patterns. The primary outcome is % heavy drinking during the trial.
Condition | Intervention | Phase |
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Alcohol Dependence |
Drug: baclofen Drug: placebo Behavioral: BRENDA counseling |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IIIa Trial of Baclofen for Alcohol Dependence |
Enrollment: | 80 |
Study Start Date: | April 2005 |
Study Completion Date: | June 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Baclofen
|
Drug: baclofen
10 mg Baclofen administered tid for 11 weeks
Behavioral: BRENDA counseling
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2: Placebo Comparator
Placebo
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Drug: placebo
Placebo administered tid for 11 weeks
Behavioral: BRENDA counseling
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The study will explore the efficacy and tolerability of a 12-week regimen of 10 mg t.i.d. baclofen vs. placebo in conjunction with behavioral therapy for reducing heavy drinking in 80 alcohol dependent individuals. Prior studies (Addolorato et al. 2000, 2002; Flannery et al., 2004) have found that baclofen reduces self-reported anxiety and craving; therefore, the proposed study also will assess baclofen's ability to reduce symptoms of these affective states. Furthermore, in our pilot study (Flannery et al, 2004), women appeared to respond more consistently than men, and therefore the study will also be balanced by gender.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics.
However, subjects who have been on stable doses of the antidepressants fluoxetine, sertraline, paroxetine, citalopram, ecitalapram, trazodone or venlafaxine for two months will be eligible. Subjects who have been taking benzodiazepines for alcohol detoxification will be required to have a washout period of at least five half-lives (approximately 5 days) from those medications before being randomized.
United States, North Carolina | |
University of North Carolina at Chapel Hill School of Medicine | |
Chapel Hill, North Carolina, United States, 27599-7160 |
Principal Investigator: | James C Garbutt, MD | UNC Department of Psychiatry |
Responsible Party: | UNC Department of Psychiatry ( James C. Garbutt, MD/Principal Investigator ) |
Study ID Numbers: | baclofen-unc-0507 |
Study First Received: | February 7, 2008 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00877734 History of Changes |
Health Authority: | United States: Institutional Review Board |
alcohol dependence baclofen pharmacotherapy women |
Neurotransmitter Agents Mental Disorders GABA Agonists Muscle Relaxants, Central Baclofen Alcoholism |
Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders Peripheral Nervous System Agents Ethanol |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Baclofen Physiological Effects of Drugs Disorders of Environmental Origin Neuromuscular Agents Pharmacologic Actions Mental Disorders GABA Agonists |
Muscle Relaxants, Central Therapeutic Uses Alcoholism Substance-Related Disorders GABA Agents Alcohol-Related Disorders Peripheral Nervous System Agents Central Nervous System Agents |