CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Recruiting· 100 target
Drug / intervention
Detoxification Program +2 moreother
Likely dose
Not stated in record
Key inclusion· 6
  • ✓DSM-5 diagnosis of AUD confirmed by SCID-5 and Principal Investigators
  • ✓Males: >14 drinks/week and >4 drinks/day at least twice weekly; females: >7 drinks/week and >3 drinks/day at least twice weekly during 30 consecutive days within 90 days prior to intake
  • ✓Willingness to abstain from alcohol and engage in quit attempt
  • ✓Able to read and write English
Key exclusion· 7
  • ✕Current significant medical condition (neurological, cardiovascular, endocrine, renal, liver, thyroid) affecting data integrity; elevated liver enzymes in AUD not exclusionary
  • ✕Past or current neurological disorders including multiple sclerosis, stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder
  • ✕Current significant psychiatric disorder including severe substance use disorder (other than alcohol/tobacco) and past/current psychotic symptoms
  • ✕Regular use in past 6 months of prescription, psychoactive or herbal medications impacting data integrity (e.g., antidepressants, antipsychotics, anxiolytics, naltrexone)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05957159
NCT05957159Early Ph 1RecruitingOn TrackUpdated 15mo ago
CompareCT.gov

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

Yale University·interventional·Posted Jul 24, 2023·Updated Apr 1, 2025

In Brief

A Early Phase 1 clinical trial evaluating Detoxification Program, PKAB, and 1 other intervention for Alcohol Use Disorder. Currently recruiting, targeting 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Early Ph 1Recruiting
20242025202620272028
First PostedJul 24, 2023
Enrollment StartNov 7, 2023
Primary CompletionAug 1, 2028
Study CompletionNov 1, 2028
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 2.9 years agoPrimary completion in 2.1 years

Interventions

Detoxification Programother

Patients will begin inpatient or outpatient detoxification prior to completing imaging

PKABradiation

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

CFNradiation

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