Brain Imaging for Alcoholism
(Mu Kappa Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not require participants to stop taking their current medications. However, if you regularly use prescription, psychoactive, or herbal medications that could affect the study data, you may not be eligible to participate.
What data supports the effectiveness of the drug nalmefene in treating alcoholism?
Is nalmefene safe for human use?
How does the drug nalmefene differ from other treatments for alcoholism?
Nalmefene is unique because it acts as a partial agonist for the κ-opioid receptor and a pure antagonist for the δ and µ receptors, which helps to reduce alcohol consumption by modulating dopamine levels in the brain. This mechanism can alleviate negative emotional states associated with alcohol dependence, unlike naltrexone, which is a pure antagonist at all these receptors.12358
What is the purpose of this trial?
The primary objective of this multimodal positron emission tomography (PET) study is to use PET brain imaging to measure both MOR (Mu-Opioid receptors) and KOR (kappa-opioid receptors) in participants with alcohol use disorder (AUD) and to quantify the relationships between MOR and KOR, separately and jointly, to key clinical outcomes (e.g., craving, mood, withdrawal, time to lapse) during a quit attempt.
Research Team
Kelly Cosgrove, PhD
Principal Investigator
Yale University
Eligibility Criteria
This trial is for adults with Alcohol Use Disorder (AUD) who drink heavily and are diagnosed according to DSM-5 criteria. Men must consume more than 14 drinks weekly, exceeding 4 per day twice a week; women over 7 weekly, exceeding 3 per day twice. Participants must be willing to try quitting alcohol and can read/write English.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Detoxification
Participants with AUD undergo a detoxification program for 1-3 days before PET imaging
Early Abstinence
Participants with AUD are monitored for changes in MOR and KOR availability during early abstinence
Outpatient Quit Attempt
Participants continue abstinence with outpatient support and contingency management
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CFN
- Detoxification Program
- PKAB
Detoxification Program is already approved in European Union, United States for the following indications:
- Reduction of alcohol consumption in adults with alcohol dependence
- Complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator