Recruiting
Early Phase 1

Opioid Receptor Imbalance

Sponsor:

Yale University

Code:

NCT05957159

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Interventions

Detoxification Program

PKAB

CFN

Study Details

Brief summary:

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

Alcohol Use Disorder

Study ID

NCT05957159

Start date

Nov 7, 2023

Status verified date

Sep, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., SCID-5 ascertained diagnosis, confirmed by the Principal Investigators);
  • Participants with AUD will meet the following drinking criteria: males will drink > 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink > 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake;
  • Participants with AUD will indicate willingness to abstain from alcohol and engage in a quit attempt;
  • Healthy subjects will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic drinks per week with no heavy drinking days (i.e., >4 drinks/day for men; >3 drinks/day for women) in the last 30 days;
  • Able to read and write English and to provide voluntary, written informed consent;
  • Agree to have blood drawn for genotyping of the OPRM1 which has been shown to impact the \[11C\]CFN outcome measure, BPND50.

Exclusion Criteria:

  • Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary);
  • Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder;
  • Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\*), and past or current psychotic symptoms;
  • Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data (e.g., naltrexone); No subject will be asked to stop taking medication to participate in the study;
  • Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD;
  • Contraindications to MRI such as claustrophobia or metal in their body;
  • Subjects whose participation would cause them to exceed yearly radiation limits for research subjects

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Alcohol Use Disorder population completing Detoxification

Subjects will be asked to complete both 90 minute \[11C\]CFN and 90 minute \[11C\]PKAB PET Imaging after 1-3 days of a detoxification program.

experimental: Healthy Control population

Subjects will be asked to complete both a 90 minute \[11C\]CFN and a 90 minute \[11C\]PKAB PET Imaging.

Interventions

Detoxification Program

Patients will begin inpatient or outpatient detoxification prior to completing imaging

PKAB

90 PET Imaging Scan using \[11C\]LY2795050 (AKA \[11C\]PKAB)

CFN

90 Pet Imaging Scan using \[11C\]-Carfentanil

Primary outcome measure

  • Regional binding availability and volume of distribution of (Mu-Opioid receptors) [ Time Frame: Within first 6 days of abstinence ]
  • Regional binding availability and volume of distribution of (Mu-Opioid receptors) [ Time Frame: Between 3 to 6 weeks into alcohol cessation ]
  • Regional binding availability and volume of distribution of (Kappa-Opioid receptors) [ Time Frame: Within first 6 days of abstinence ]
  • Regional binding availability and volume of distribution of (Kappa-Opioid receptors) [ Time Frame: Between 3 to 6 weeks into alcohol cessation ]
  • Alcohol Cue Reactivity Craving [ Time Frame: Within first 6 days of abstinence ]
  • Change in Alcohol Withdrawal [ Time Frame: Up to 1 month prior to initial imaging and up to 6 days into alcohol cessation ]
  • Change in Alcohol Use [ Time Frame: Up to 1 month prior to initial imaging and up to 6 days into alcohol cessation ]
  • Change in Alcohol Craving [ Time Frame: Up to 1 month prior to initial imaging and up to 6 days into alcohol cessation ]
  • Change in Mood [ Time Frame: Up to 1 month prior to initial imaging and up to 6 days into alcohol cessation ]

Central Contacts and Locations

Central contacts

Marc Grasso

2037375083marc.grasso@yale.edu

Kelly Cosgrove, PhD

2037376969kelly.cosgrove@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Kelly Cosgrove, PhD

203-737-6969kelly.cosgrove@yale.edu

Principal Investigator:

Kelly Cosgrove, PhD

More Information

Sponsor

Yale University

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Alcohol
  • Alcohol cessation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-09.