Actively Recruiting

Early Phase 1
Age: 21Years - 70Years
All Genders
Healthy Volunteers
NCT05957159

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

Age: 21Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06519

Actively Recruiting

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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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