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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05957159
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Detoxification Program — OTHER
    Patients will begin inpatient or outpatient detoxification prior to completing imaging
  • PKAB — RADIATION
    90 PET Imaging Scan using \[11C\]LY2795050 (AKA \[11C\]PKAB)
  • CFN — RADIATION
    90 Pet Imaging Scan using \[11C\]-Carfentanil

Study Details

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.

Key Dates

Start date
Nov 7, 2023
Status verified
Mar 2025
Primary completion
Aug 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Regional binding availability and volume of distribution of (Mu-Opioid receptors) [ Time Frame: Within first 6 days of abstinence ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06519
Kelly Cosgrove, PhD
203-737-6969
Kelly Cosgrove, PhD (PRINCIPAL_INVESTIGATOR)

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