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Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

This study is currently recruiting participants.
Verified September 2017 by Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625611
First Posted: June 21, 2012
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 97
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01625611     History of Changes
Other Study ID Numbers: 1011007710
First Submitted: June 19, 2012
First Posted: June 21, 2012
Last Update Posted: September 25, 2017
Last Verified: September 2017

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
Ethanol
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents