Clinical Trial: Understanding of the Pathophysiology and Psychopharmacology of Binge Drinking

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessing Changes in the Brain Melanocortin System and Sensory Processing in Response to Alcohol to Advance Our Understanding of the Pathophysiology and Psychopharmacology of Bin

Brief 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 and assess cortical adaptation to tactile stimuli in subjects with binge drinking.

Detailed 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 and assess cortical adaptation to tactile stimuli in subjects with binge drinking.

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 Da
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

  • Tolerability of Naltrexone/Buproprion [ Time Frame: 12 weeks ]
    Tolerability will be assessed by probing for adverse effects.
  • Change in Drinking Behavior [ Time Frame: 12 weeks ]
    Drinking behavior including frequency and intensity of binge drinking will be accessed using the Time Line Follow Back Data.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in Craving [ Time Frame: 12 weeks ]

Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6.


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: June 15, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: May 7, 2017
Last Verified: May 2017