Efficacy and Tolerability of Baclofen for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877734
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : September 14, 2012
Information provided by:
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Dependence Drug: baclofen Drug: placebo Behavioral: BRENDA counseling Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIIa Trial of Baclofen for Alcohol Dependence
Study Start Date : April 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: baclofen
10 mg Baclofen administered tid for 11 weeks
Other Name: Lioresal
Behavioral: BRENDA counseling
Placebo Comparator: 2
Drug: placebo
Placebo administered tid for 11 weeks
Behavioral: BRENDA counseling

Primary Outcome Measures :
  1. % heavy drinking days [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. % relapse [ Time Frame: 2 years ]
  2. % abstinent days [ Time Frame: 2 years ]
  3. depression symptoms [ Time Frame: 2 years ]
  4. anxiety symptoms [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Men and women between the ages of 18 and 60 meeting DSM-IV criteria for current alcohol dependence.
  2. Must have had at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to screening.
  3. Able to understand and sign written informed consent.
  4. Must be willing to refrain from drinking for three days prior to randomization day.
  5. Express a desire to achieve abstinence or to greatly reduce alcohol consumption.
  6. Must have a stable residence and be able to identify an individual who could locate subject if needed.

Exclusion Criteria

  1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., cirrhosis, kidney impairment, unstable hypertension, hypotension, diabetes mellitus, seizure disorder).
  2. Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
  3. History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
  4. 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.
  5. Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
  6. AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or creatinine > ULN.
  7. Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence.
  8. Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
  9. Women who are breastfeeding.
  10. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.
  11. Participation in any clinical trial within the last 60 days.
  12. Court-mandated participation in alcohol treatment or pending incarceration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877734

United States, North Carolina
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States, 27599-7160
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: James C Garbutt, MD UNC Department of Psychiatry

Responsible Party: James C. Garbutt, MD/Principal Investigator, UNC Department of Psychiatry Identifier: NCT00877734     History of Changes
Other Study ID Numbers: baclofen-unc-0507
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: April 2011

Keywords provided by University of North Carolina, Chapel Hill:
alcohol dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs