An Open Label Trial of Bupropion and Naltrexone for Binge Drinking
Condition: Binge Drinking
MeSH terms: Binge Drinking
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking
      of bupropion and naltrexone for binge drinkers.

      Participants: Investigators will recruit 12 men or women ages 21-34 years who exhibit 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. Subjects with overt physical dependence on alcohol,
      significant medical problems including seizures or bulimia, other substance use disorder
      except for occasional marijuana (based on toxicology screen) or significant psychiatric
      illness will be excluded.

      Procedures (methods): As a first step in human trials investigators will give open label
      bupropion + naltrexone to active binge drinking subjects. The primary goal here is to assess
      tolerability and acceptability though changes in binge drinking and subjective sense of
      "effect" will be gathered as well. Investigators will also test cortical adaptation to binge
      drinking by completing tactile sensory testing and comparing the results to controls and
      individuals with overt physical dependence on alcohol. Investigators will recruit subjects
      using the e-mail listserve for UNC students, faculty and staff.

      Investigators will use standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk)
      and naltrexone 50 mg/d 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. Naltrexone will
      be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84. Subjects will be
      seen at screening and then at Weeks 0, 1, 3, 5, 8 and 12. Subjects will be breathalyzed and
      receive Medical Management counseling to encourage compliance and progress towards drinking
      goals. Investigators will use the Time Line Follow-Back approach to assess alcohol
      consumption history modified to include time taken to consume alcohol and define a binge.
      They will also measure craving for alcohol and will assess tolerability by probing for
      adverse effects. Key outcomes of interest include tolerability and acceptability, drinking
      behavior including frequency and intensity of binge drinking, and craving for alcohol.
      Because this is an open-label trial without a placebo comparison group no formal statistics
      will be completed and efficacy will not be assessed. Instead, this pilot study will inform
      investigators about the recruitment of binge drinkers, the tolerability and acceptability of
      bupropion/naltrexone in this population and potential efficacy signals.
    

Intervention name(s): Naltrexone; Bupropion
Intervention type(s): Drug; Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment