RECRUITING

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-08

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05042102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Gihyun Yoon, MD

CONTACT

203-932-5711

gihyun.yoon@yale.edu

Principal Investigator

Gihyun Yoon, MD

PRINCIPAL_INVESTIGATOR

Yale University, VA Connecticut Healthcare System

Study Locations (Sites)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516

United States

Collaborators and Investigators

Sponsor: VA Connecticut Healthcare System

Gihyun Yoon, MD, PRINCIPAL_INVESTIGATOR, Yale University, VA Connecticut Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-08

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2022-08-08

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder