An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

• Status: Completed
• Trial end date: 2017-12-13
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.

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

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: North Carolina Translational and Clinical Sciences Institute
• Treatments: Bupropion; Naltrexone

Criteria

Inclusion Criteria:

1. Men and women between the ages of 21 and 34 years.

2. A minimum of 5/3 (men/women) or more binge drinking episodes per month over the past three months. A binge drinking episode is defined as the consumption of 5/4 (men/women) standard drinks (~12 gms ethanol) in about a two hour period. Subjects may meet DSM-V criteria for mild or moderate alcohol use disorder.

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. Must have a stable residence and be able to identify an individual who could contact participant if needed.

6. Have a goal of sobriety or significantly reducing alcohol intake.

Exclusion Criteria

1. Presence of physical dependence on alcohol as assessed by clear tolerance to alcohol or alcohol withdrawal symptoms based on SCID interview or a Severe Alcohol Use Disorder (>5 SCID DSM-V symptoms).

2. Bupropion is contraindicated in individuals with a history of bulimia or a seizure disorder and naltrexone is contraindicated in acute liver disease and in patients using or misusing opioids.

3. 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, anorexia/bulimia, severe depression, or suicidal ideation.

4. Other substance abuse or dependence disorder other than nicotine or cannabis abuse.

5. Concurrent use of anticonvulsants. 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. Bupropion is commonly added to antidepressants for augmentation so the use of another antidepressant does not represent a safety concern. Prior history of adverse reaction to bupropion or naltrexone.

6. AST or ALT > 3.5 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 problems.

11. Participation in any clinical trial within the past 60 days that would have safety concerns for the trial.

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