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Understanding Opioid Receptors in Alcohol Use Disorder

This study is looking at how two types of opioid receptors in the brain, Mu-Opioid receptors (MOR) and Kappa-Opioid receptors (KOR), are involved in alcohol use disorder (AUD). Researchers will use special brain scans called PET imaging with tracers like [11C]LY2795050 (PKAB) and [11C]-Carfentanil (CFN) to measure these receptors in people with AUD and healthy individuals. The goal is to see if there are differences in these receptors and how those differences relate to things like craving, mood, and withdrawal during an attempt to stop drinking. You may be able to join if you are 21 to 70 years old and have an AUD diagnosis, meeting specific drinking criteria. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants, including those with Alcohol Use Disorder and healthy controls. It is not specified if the study is randomized or blinded.
What's involved
Participants will undergo a detoxification program (inpatient or outpatient) and have two PET imaging scans using [11C]PKAB and [11C]-Carfentanil. Measurements will be taken within the first 6 days of abstinence and again between 3 to 6 weeks into alcohol cessation.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure receptor levels within the first 6 days of abstinence and again between 3 to 6 weeks into alcohol cessation.

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NCT05957159

Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder

Recruiting
EARLY_PHASE1Ages 21–70InterventionalBasic science
Yale University
~100 participants
Updated 2025-04-01 on ClinicalTrials.gov
What's tested:Detoxification ProgramPKABCFN

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Regional binding availability and volume of distribution of (Mu-Opioid receptors)
Measured over Within first 6 days of abstinence
+8 more outcomes measured

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorderOPRM1 Gene

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Kelly Cosgrove, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Marc Grasso
[email protected]
2037375083
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Regional binding availability and volume of distribution of (Mu-Opioid receptors)Within first 6 days of abstinence

    Time activity curves will be extracted from brain regions of interest during \[11C\]CFN PET Imaging. AUD subjects will be asked to complete this within first 6 days of abstinence. Healthy control subjects will be matched based on sex(Male/Female), smoking status (current/former/nonsmoker), and BMI (kg/m\^2)

  • Regional binding availability and volume of distribution of (Mu-Opioid receptors)Between 3 to 6 weeks into alcohol cessation

    Time activity curves will be extracted from brain regions of interest during \[11C\]CFN PET Imaging. AUD subjects will be asked to complete this 3 -6 weeks into alcohol cessation. Healthy control subjects will be matched based on sex(Male/Female), smoking status (current/former/nonsmoker), and BMI (kg/m\^2)

  • Regional binding availability and volume of distribution of (Kappa-Opioid receptors)Within first 6 days of abstinence

    Time activity curves will be extracted from brain regions of interest during \[11C\]PKAB PET Imaging. AUD subjects will be asked to complete this within first 6 days of abstinence. Healthy control subjects will be matched based on sex(Male/Female), smoking status (current/former/nonsmoker), and BMI (kg/m\^2)

  • Regional binding availability and volume of distribution of (Kappa-Opioid receptors)Between 3 to 6 weeks into alcohol cessation

    Time activity curves will be extracted from brain regions of interest during \[11C\]PKAB PET Imaging. AUD subjects will be asked to complete this 3 -6 weeks into alcohol cessation. Healthy control subjects will be matched based on sex(Male/Female), smoking status (current/former/nonsmoker), and BMI (kg/m\^2)

  • Alcohol Cue Reactivity CravingWithin first 6 days of abstinence

    Investigators will follow the paradigm developed for the NIAAA Human Laboratory Medication Screening Program (HLAB). In the paradigm, participants will be first exposed to a glass of water and then to their typical alcoholic beverage, separated by a 90 second rest period. They will be instructed to not drink but to sniff the beverages for a fixed duration. Immediately after, alcohol craving and beverage liking will be assessed. AUD subjects will be asked to complete this within first 6 days of abstinence. Healthy control subjects will be matched based on sex(Male/Female), smoking status (current/former/nonsmoker), and BMI (kg/m\^2)

  • Change in Alcohol WithdrawalUp to 1 month prior to initial imaging and up to 6 days into alcohol cessation

    Withdrawal will be assessed using The Clinical Institute Withdrawal Assessment (CIWA-R)64. AUD and Healthy controls will be asked to complete this paper questionnaire up to 1 month prior to CFN and PKAB PET Imaging and once again up to 6 days into alcohol cessation for AUD population Range: 0- 67, higher scores indicating more symptoms of withdrawal.

  • Change in Alcohol UseUp to 1 month prior to initial imaging and up to 6 days into alcohol cessation

    Assessed using the TimeLine Followback (TLFB)62 and BACtrack Skyn; AUD and Healthy controls will be asked to complete this paper questionnaire up to 1 month prior to CFN and PKAB PET Imaging and once again up to 6 days into alcohol cessation for AUD population. Calendar style open ended. Minimum 0 alcohol uses in past month -31 sittings of alcohol in past month

  • Change in Alcohol CravingUp to 1 month prior to initial imaging and up to 6 days into alcohol cessation

    Craving will be assessed with Alcohol Craving Scale (ACS, adapted from Singleton et al.63), Range: 47 to 329, higher scores indicate higher craving to alcohol

  • Change in MoodUp to 1 month prior to initial imaging and up to 6 days into alcohol cessation

    Mood, anhedonia symptoms will be assessed with the Center for Epidemiologic Studies Depression Scale (CES-D) Range : 0 to 60. Higher scores indicate more symptoms of depression.