Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
|ClinicalTrials.gov Identifier: NCT01625611|
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking||Drug: Naltrexone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||March 15, 2018|
|Actual Study Completion Date :||March 22, 2018|
Naltrexone 100 mg titrated over one week
Other Name: Revia
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625611
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Suchitra Krishnan-Sarin, Ph.D.||Yale University|