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Recruiting Phase 2 NCT05042102

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Trial Parameters

Condition Alcohol Use Disorder
Sponsor VA Connecticut Healthcare System
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 160
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2022-08-08
Completion 2027-05-31
Interventions
Donepezil + Cognitive remediation therapy (CRT)Donepezil + Placebo CRTPlacebo medication + Cognitive remediation therapy (CRT)

Brief Summary

The goal of the project is to evaluate whether donepezil + cognitive remediation therapy is superior to placebo in reducing heavy drinking in patients with alcohol use disorder in a double-blind, placebo-controlled trial.

Eligibility Criteria

Inclusion criteria: 1. Males and females 18-80 years of age 2. Fluency in English and a 6th grade or higher reading level 3. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current alcohol use disorder (subjects should have a primary alcohol use disorder \[AUD\] diagnosis, but may have concurrent occasional use of other substances) 4. Last alcohol use and at least one heavy drinking day within the past 30 days 5. Willingness to attend follow-up assessments at 13 weeks 6. Willingness to submit to Urine Toxicology screenings Exclusion criteria: 1. Lifetime diagnosis of a psychotic disorder, not induced by drug use 2. Current treatment with opioids or benzodiazepines, which may affect new learning 3. Involvement in a legal case that may lead to incarceration during the study period 4. Residential plans that would interfere with participation 5. Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's c

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