Actively Recruiting
Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder
Led by Yale University · Updated on 2025-04-01
100
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with alcohol use disorder (AUD) must have a current diagnosis confirmed by DSM-5 criteria and Principal Investigators
- Male participants must have drunk more than 14 drinks per week and exceeded 4 drinks per day at least twice per week within a consecutive 30-day period in the last 90 days
- Female participants must have drunk more than 7 drinks per week and exceeded 3 drinks per day at least twice per week within a consecutive 30-day period in the last 90 days
- Participants with AUD must be willing to abstain from alcohol and engage in a quit attempt
- Healthy control participants must have no current or past AUD or significant substance use disorder and drink less than 5 alcoholic drinks per week with no heavy drinking days in the last 30 days
- Able to read and write English and provide voluntary written informed consent
- Agree to have blood drawn for genetic testing related to opioid receptor measures
You will not qualify if you...
- Current significant medical conditions affecting brain, cardiovascular, endocrine, renal, liver, or thyroid health that could impact study data (except elevated liver enzymes in AUD)
- Past or current neurological disorders including multiple sclerosis, stroke, brain tumors, traumatic brain injury with loss of consciousness, or seizure disorder
- Current significant psychiatric disorders including severe substance use disorders other than alcohol or tobacco, or psychotic symptoms
- Regular use in past 6 months of prescription, psychoactive, or herbal medications that could affect study data (e.g., antidepressants, antipsychotics, anxiolytics, naltrexone); no medication will be stopped to participate
- Women who are pregnant, nursing, or not using approved birth control methods unless surgically sterile or postmenopausal
- Contraindications to MRI such as claustrophobia or metal in the body
- Participation would cause exceeding yearly radiation limits for research subjects
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
M
Marc Grasso
CONTACT
K
Kelly Cosgrove, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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