Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01625611
First received: June 19, 2012
Last updated: June 18, 2014
Last verified: June 2014

June 19, 2012
June 18, 2014
February 2011
June 2018   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01625611 on ClinicalTrials.gov Archive Site
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.
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 FHP and FHN heavy drinkers and to determine if baseline KOR level is related to either baseline drinking or responsivity to NTX.
Not Provided
Not Provided
 
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alcohol Drinking
Drug: Naltrexone
Naltrexone 100 mg titrated over one week
Other Name: Revia
Experimental: Naltrexone
Intervention: Drug: Naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
June 2018
June 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 21-50
  • Able to read English at 6th grade level or higher and to complete study evaluations
  • Regular alcohol drinker

Exclusion Criteria:

  • Individuals who are seeking alcohol treatment
  • Medical conditions that would contraindicate the use of study medication
  • Regular use of other substances
Both
21 Years to 50 Years
No
United States
 
NCT01625611
1011007710
Yes
Yale University
Yale University
Not Provided
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP