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NCT01625611 · ClinicalTrials.gov registry record · Phase 1
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT01625611: Completed Phase 1 study, sponsored by Yale University.
NCT01625611 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625611, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2011-02 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 1 |
What the finished NCT01625611 record still lists
NCT01625611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Naltrexone is the first listed.
NCT01625611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625611 about?
NCT01625611 is a clinical study titled "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 mole...
What is the current status of trial NCT01625611?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2011-02. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT01625611?
The interventions under investigation include: Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01625611?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625611's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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