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

The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder

This study is testing if a combination of a medication called donepezil and cognitive training can help people with alcohol use disorder drink less.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: VA Connecticut Healthcare System (fed)
• Locations: 1 site (West Haven, Connecticut)
• Trial ID: NCT05042102 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 who meet the criteria for alcohol use disorder and have experienced heavy drinking within the past month.

Not a fit: Patients with a history of psychotic disorders or those currently using opioids or benzodiazepines may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for individuals struggling with alcohol use disorder, potentially leading to reduced drinking and improved cognitive function.

How similar studies have performed: While the combination of donepezil and cognitive training is a novel approach, similar studies exploring cognitive interventions for alcohol use disorder have shown promise.

Eligibility criteria

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 this trial is running

West Haven, Connecticut

• 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

Conditions: Alcohol Use Disorder