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
  Purpose

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.


Condition Intervention Phase
Alcohol Drinking
Drug: Naltrexone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
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)
Arms Assigned Interventions
Experimental: Naltrexone Drug: Naltrexone
Naltrexone 100 mg titrated over one week
Other Name: Revia

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625611

Locations
United States, Connecticut
Sac, Cmhc Recruiting
New Haven, Connecticut, United States, 06519
Contact: Nicholas Franco, B.A.    203-974-7679    nicholas.franco@yale.edu   
Contact: Dana Cavallo, Ph. D.    203 974-7607    dana.cavallo@yale.edu   
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D.         
Sub-Investigator: Evan Morris, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01625611     History of Changes
Other Study ID Numbers: 1011007710
Study First Received: June 19, 2012
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Alcohol
Drinking
Drinkers
Alcohol Drinking
Naltrexone
Alcohol Dependence
Alcohol Abuse
Alcohol-Related Disorders
Ethanol
Alcoholism

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014