Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
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.
Key facts
- Study ID
- NCT05042102
- Run by
- VA Connecticut Healthcare System
- People needed
- 160
- Starts
- 2022-08-08
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females 18-80 years of age
- Fluency in English and a 6th grade or higher reading level
- 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)
- Last alcohol use and at least one heavy drinking day within the past 30 days
- Willingness to attend follow-up assessments at 13 weeks
- Willingness to submit to Urine Toxicology screenings
You may not qualify if…
- Lifetime diagnosis of a psychotic disorder, not induced by drug use
- Current treatment with opioids or benzodiazepines, which may affect new learning
- Involvement in a legal case that may lead to incarceration during the study period
- Residential plans that would interfere with participation
- Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)
- An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
- Pre-morbid intelligence quotient (IQ) estimate below 70
- Unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely
- Unwillingness to provide contact information of someone who can help study staff contact the subjects in the event that study staff are unable to maintain contact directly
- Allergy to donepezil
- Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
- Imminent suicidal or homicidal risk
- Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
Where it is running
- VA Connecticut Healthcare System — West Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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