Clinical Trial: Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

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

Official Title: Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

Brief Summary: The primary purpose of the study is to increase our knowledge of receptor function in the brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has been approved for the treatment of alcohol dependence. Receptors are special molecules in the brain to which other molecules (neurotransmitters) attach during the normal every-day workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking behavior. This study will try to determine if naltrexone's ability to attach to these receptors is related to its effectiveness. We will use PET (positron emission tomography) for this study. PET is a type of imaging device found in nuclear medicine. It is used for tracking the presence of injected radioactive materials in the body.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome:

  • Occupancy of KOR by NTX and drinking [ Time Frame: 6-8 days after treatment with naltrexone ]
    To determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.
  • Relationship between NTX responsivity and occupancy of KOR [ Time Frame: 6-8 days after treatment with naltrexone ]
    To determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers.


Original Primary Outcome: Same as current

Current Secondary Outcome: Baseline KOR differences [ Time Frame: at baseline prior to treatment with naltrexone ]

To determine if baseline levels of KOR differ between family history positive (FHP) and family history negative (FHN) heavy drinkers and to determine if baseline KOR level is related to either baseline drinking or responsivity to NTX.


Original Secondary Outcome: Baseline KOR differences [ Time Frame: at baseline prior to treatment with naltrexone ]

To determine if baseline levels of KOR differ between FHP and FHN heavy drinkers and to determine if baseline KOR level is related to either baseline drinking or responsivity to NTX.


Information By: Yale University

Dates:
Date Received: June 19, 2012
Date Started: February 2011
Date Completion: June 2018
Last Updated: August 23, 2016
Last Verified: August 2016