NCT05042102PHASE2Recruiting
Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
VA Connecticut Healthcare System
Start Date
8/8/2022
Completion Date
10/31/2026
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
Age Range: 18 years to 80 years
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 chorea, moderate or greater TBI)
6. An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
7. Pre-morbid intelligence quotient (IQ) estimate below 70
8. Unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely
9. 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
10. Allergy to donepezil
11. Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
12. Imminent suicidal or homicidal risk
13. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
Interventions
COMBINATION_PRODUCT
Donepezil + Cognitive remediation therapy (CRT)
COMBINATION_PRODUCT
Donepezil + Placebo CRT
COMBINATION_PRODUCT
Placebo medication + Cognitive remediation therapy (CRT)
COMBINATION_PRODUCT
Placebo medication + Placebo CRT
Conditions
Alcohol Use Disorder
Locations
VA Connecticut Healthcare System
West Haven, Connecticut 06516
United States