Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

• Status: Completed
• Trial end date: 2017-10-26
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Baclofen; Ethanol

Criteria

Inclusion Criteria:

1. Men and women between the ages of 18 and 65 meeting Diagnostic and Statistical Manual (DSM)-IV criteria for current alcohol dependence.

2. More than 14 drinks (women) or 21 drinks (men) per week including at least 2 heavy drinking days (men > 5 drinks/day; women > 4 drinks/day) per week in the 30-day period prior to screening. In addition we will recruit 50% of individuals who have a mean of ≥14 drinks/drinking day (men) or ≥10 drinks/drinking day (women) in the 30 days prior to screening.

3. Ability to understand and sign written informed consent.

4. Must have a 0.0 gms/dL breathalyzer reading on the day of screening and 0.0 gms/dL on the day of randomization.

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 contact participant 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., renal insufficiency, cirrhosis, unstable hypertension, diabetes mellitus, seizure disorder). Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, severe depression, or suicidal ideation.

2. Other substance abuse or dependence disorder other than nicotine or alcohol or cannabis abuse.

Occasional use of cocaine is acceptable.

3. Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics with the exception of stable doses of antidepressants for one month. Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.

4. Prior history of adverse reaction to baclofen.

5. Creatinine level > Upper Limit of Normal (ULN) or Estimated Glomerular Filtration Rate < age norm.

6. aspartate aminotransferase (AST), or alanine transaminase (ALT) > 5 times ULN or bilirubin > 1.5 X 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 past 60 days.

12. Court-mandated participation in alcohol treatment or pending incarceration.