Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors|
- Occupancy of KOR by NTX and drinking [ Time Frame: 6-8 days after treatment with naltrexone ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers.
- Baseline KOR differences [ Time Frame: at baseline prior to treatment with naltrexone ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Naltrexone 100 mg titrated over one week
Other Name: Revia
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625611
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|Contact: Nicholas Franco, B.A. 203-974-7679 firstname.lastname@example.org|
|Contact: Dana Cavallo, Ph. D. 203 974-7607 email@example.com|
|Principal Investigator: Suchitra Krishnan-Sarin, Ph.D.|
|Sub-Investigator: Evan Morris, Ph.D.|
|Principal Investigator:||Suchitra Krishnan-Sarin, Ph.D.||Yale University|