An Open Label Trial of Bupropion and Naltrexone for Binge Drinking
Condition: Binge Drinking
MeSH terms: Binge Drinking
Intervention: Naltrexone; Bupropion
Intervention description: Standard clinical doses of naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84.; Standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
Intervention MeSH terms: Naltrexone; Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Maximum age: 34 Years
Healthy volunteers: No

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.
    

Eligibility 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.