Phase 1
Completed N=59
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Alcohol Drinking
Source: ClinicalTrials.gov NCT01625611 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Occupancy of KOR by NTX and Drinking — 92 % Occupancy
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occupancy of KOR by NTX and Drinking |
92 | — |
| PRIMARY Relationship Between NTX Responsivity and Occupancy of KOR |
84 | — |
| SECONDARY Baseline KOR Differences |
91.2; 94.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01625611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.