Combining donepezil with cognitive training to help reduce heavy drinking in people with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of donepezil combined with cognitive remediation therapy in reducing heavy drinking among patients diagnosed with alcohol use disorder. Participants will be randomly assigned to receive either the active treatment or a placebo in a double-blind manner. The study will assess the outcomes over a 13-week period, focusing on changes in drinking behavior and cognitive function. The trial includes both medication and therapy components to explore their combined effects on alcohol use disorder.

Why it matters

Who can join: the full rules

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

Where it's running

• VA Connecticut Healthcare System
  West Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Gihyun Yoon, MD — Yale University, VA Connecticut Healthcare System
• Study coordinator: Gihyun Yoon, MD
• Email: gihyun.yoon@yale.edu
• Phone: 203-932-5711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.