NCT05042102 · VA Connecticut Healthcare System
Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
What this study is about
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 where neither patients nor doctors know which treatment is given, compared against an inactive treatment trial.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
Donepezil + Cognitive remediation therapy (CRT)
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.
COMBINATION_PRODUCT
Donepezil + Placebo CRT
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.
COMBINATION_PRODUCT
Placebo medication + Cognitive remediation therapy (CRT)
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.
COMBINATION_PRODUCT
Placebo medication + Placebo CRT
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.
Primary outcome measures
Heavy drinking days
Time frame: 13 weeks of active intervention
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- West Haven, Connecticut
Collaborators
Yale University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations