Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

Yale University

Status and phase: Completed; Phase 1

Conditions: Alcohol Drinking

Treatments: Drug: Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01625611

U54AA027989 (U.S. NIH Grant/Contract)

R01AA021818-01A1 (U.S. NIH Grant/Contract)

1011007710

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Naltrexone

Experimental group

Treatment:

Drug: Naltrexone