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 — OTHERPatients will begin inpatient or outpatient detoxification prior to completing imaging
- PKAB — RADIATION90 PET Imaging Scan using \[11C\]LY2795050 (AKA \[11C\]PKAB)
- CFN — RADIATION90 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 DetoxificationSubjects 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 populationSubjects 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
- Marc Grasso2037375083
- Kelly Cosgrove, PhD2037376969
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | Kelly Cosgrove, PhD (PRINCIPAL_INVESTIGATOR) |
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