Trial record 1 of 15 for:    baclofen alcohol dependence
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Efficacy and Tolerability of Baclofen for Alcohol Dependence

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00877734
First received: February 7, 2008
Last updated: September 13, 2012
Last verified: April 2011
  Purpose

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
Alcohol Dependence
Drug: baclofen
Drug: placebo
Behavioral: BRENDA counseling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIIa Trial of Baclofen for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • % heavy drinking days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • % relapse [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • % abstinent days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • depression symptoms [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • anxiety symptoms [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877734

Locations
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
Investigators
Principal Investigator: James C Garbutt, MD UNC Department of Psychiatry
  More Information

No publications provided

Responsible Party: James C. Garbutt, MD/Principal Investigator, UNC Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00877734     History of Changes
Other Study ID Numbers: baclofen-unc-0507
Study First Received: February 7, 2008
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Baclofen
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014