What this study is
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.
What's being tested
- Donepezil + Cognitive remediation therapy (CRT)
Intervention · COMBINATION PRODUCT
Subjects in this arm will receive (1) donepezil and (2) cognitive remediation therapy (CRT). Subjects will take 5 mg/day of oral donepezil in the evening for the first 4 weeks, then 10 mg/day of oral donepezil in the evening until week 13.
- Donepezil + Placebo CRT
Intervention · COMBINATION PRODUCT
Subjects in this arm will receive (1) donepezil and (2) placebo CRT. Subjects will take 5 mg/day of oral donepezil in the evening for the first 4 weeks, then 10 mg/day of oral donepezil in the evening until week 13.
- Placebo medication + Cognitive remediation therapy (CRT)
Intervention · COMBINATION PRODUCT
Subjects in this arm will receive (1) placebo medication and (2) cognitive remediation therapy (CRT). Subjects will take placebo oral medication in the evening for the first 4 weeks, then placebo oral medication in the evening until week 13.
- Placebo medication + Placebo CRT
Intervention · COMBINATION PRODUCT
Subjects in this arm will receive (1) placebo medication and (2) placebo CRT. Subjects will take placebo oral medication in the evening for the first 4 weeks, then placebo oral medication in the evening until week 13.
Study details
- Official title
- The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
- Sponsor
- VA Connecticut Healthcare System
- Conditions
- Alcohol Use Disorder
- Enrolling
- 160 people
- Starts
- 2022-08-08
- Est. completion
- 2027-05-31
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA Connecticut Healthcare System
West Haven, Connecticut, United States
- Gihyun Yoon, MD · Contact203-932-5711 ext. 7421gihyun.yoon@yale.edu
Recruiting
Study team
Sponsor
VA Connecticut Healthcare System
Study ID GY0010
Principal investigator
Gihyun Yoon, MD
Yale University, VA Connecticut Healthcare System
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.