Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

  • STATUS
    Recruiting
  • End date
    May 31, 2026
  • participants needed
    160
  • sponsor
    VA Connecticut Healthcare System
Updated on 10 May 2022

Summary

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.

Details
Condition Alcohol Use Disorder
Treatment Donepezil + Cognitive remediation therapy (CRT), Donepezil + Placebo CRT, Placebo medication + Cognitive remediation therapy (CRT), Placebo medication + Placebo CRT
Clinical Study IdentifierNCT05042102
SponsorVA Connecticut Healthcare System
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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)
Referred for the study within 30 days of detoxification or last alcohol use according to medical records
Willingness to attend follow-up assessments at 13 weeks
Willingness to submit to Breathalyzer screenings and 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 possible
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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