Buproprion for Binge Drinking
Condition: Alcohol Abuse
MeSH terms: Alcoholism; Binge Drinking
Intervention: Bupropion; Placebo Oral Tablet
Intervention description: Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.; Placebo will be initiated on Day 1 and continue throughout the course of the study.
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The design is a 1:1 random assignment to placebo or bupropion XL (300mg/d).
Enrollment: 42.0
Sex: All
Minimum age: 21 Years
Maximum age: 44 Years
Healthy volunteers: No

Summary:

      The present proposal is an innovative and translational clinical trial derived from exciting
      preclinical findings to test the hypothesis that treatment with the melanocortin activator
      bupropion can reduce binge drinking in humans. Furthermore, pilot data on moderating effects
      of coexisting nicotine use on the efficacy of bupropion for binge drinking population will be
      obtained. Evidence for an efficacy signal with good tolerability with this FDA approved
      medication would form the foundation to conduct a well-powered Phase II b trial. The
      development of an effective pharmacotherapy for binge drinking would be a significant
      clinical advance.

      .
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 21 and 44 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. BMI ≥18.5 (normal weight or above)

          6. Express a desire to achieve abstinence or to reduce alcohol consumption

          7. Must have a stable residence and be able to identify an individual who could contact
             participant if needed.

        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

          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.

          6. AST or ALT > 3.5 times Upper Limit of Normal (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.