Buproprion for Binge Drinking

Alcohol Abuse

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. .

The design is a 1:1 random assignment to placebo or bupropion XL (extended release) (300mg/d). The study biostatistician, will prepare the randomization schedule and include blocking by gender and nicotine dependence. Randomization will be based on a stratified block design, with gender and nicotine dependence as the stratification variables with medication/placebo randomly assigned in blocks of four. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. The University of North Carolina (UNC) Hospital's Investigational Drug Services (IDS) will prepare opaque capsules containing bupropion XL 150/300 mg and matching placebo. Capsules will be inserted into blister packs with each pack containing 1 week of medication. The IDS will receive the randomization schedule from our statistician and prepare the blister packs according to the blocked schedule with blocking for gender/nicotine dependence. Recruitment, Telephone Screen, and Full Eligibility Screening: Subjects will initially be prescreened by phone and then at full screening read and sign the informed consent. A breathalyzer test will be administered (must be 0.00 gms/dl to give informed consent), height, weight and BMI recorded and a medical history and examination completed. Over-the-counter and prescription medication use will be recorded and nicotine use documented. Complete Blood Count (CBC) with differential; serum bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT,) sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose; and urinalysis and urine toxicology completed. Women will be given a urine pregnancy test (Ub-HCG) at screening and at weeks 4, 8, and 12. Trained interviewers will conduct the psychiatric screening interview using the M.I.N.I. . The Structured Clinical Interview (SCID) Substance Use Disorders Module to establish Diagnostic and Statistical Manual (DSM-V) criteria for alcohol use disorders will be administered by one of the study doctors. The study coordinator will conduct the pretreatment 90-day Timeline Followback (TLFB) interview to identify amount of alcohol consumed and timeframe of consumption. A binge drinking episode requires a minimum of 5/4 (men/women) standard drinks consumed over about a two hour period, i.e. consuming a bottle of wine over five hours would not be coded as a binge drinking day. The Penn Alcohol Craving Scale (PACS) and the University of Rhode Island Change Assessment (URICA) will be completed and treatment goal-abstinence vs. reduction- recorded. Initial Treatment Visit (within 21 days screening): Eligible individuals will not be required to abstain from drinking alcohol prior to randomization. The study coordinator will administer a breathalyzer test (BAC must be ≤0.04 gms/d) and complete assessments as outlined in Table 1, Protection of Human Subjects. A salivary cotinine sample will be taken A 1-week blister pack of bupropion-XL or placebo with written instructions will be dispensed from the Investigational Drug Services according to the randomization block along with a 1-week back-up blister pack in case of delayed appointments or lost doses. Bupropion-XL will be titrated with 150 mg given daily for 4 days followed by 300 mg/d. Participants will be given a calendar style diary to track pill taking, drinking quantity/timing, intoxication and any side effects. Finally, participants will receive Medical Management from a trained clinician. Subsequent Treatment Visits: TLFB and PACS are gathered each visit, cotinine samples at weeks 4, 8 and 12 and URICA at week 8. Medical monitoring will be conducted by study physicians and will consist of review of vital signs, concomitant medication use, and general inquiries into side effects. The physician may recommend that medication be held for a period of time to deal with an adverse event, e.g. nausea. One month and three months following the last visit subjects will be contacted by phone to update drinking (TLFB), adverse effects and medications. Medical Management Intervention: The psychosocial support for the study will be Medical Management (MM). MM sessions average 10-15 minutes and focus on three main areas: (1) feedback on consequences of drinking; (2) encouraging compliance with medication/addressing compliance problems and (3) encouraging progress towards drinking goal- reduction or abstinence are acceptable. 10% of sessions will be audiotaped and reviewed to enhance fidelity. Medication Compliance Monitoring: Participants will record their pill taking in calendar-style diaries that will be provided and collected at each visit. Pills will be distributed in blister packs that will be returned to the study coordinator to reconcile any unused medication from the returned blister packs with participants' diary records.

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