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NCT Number: NCT05042102

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Location contact

Gihyun Yoon, MD

CONTACT

[email protected]

203-932-5711 ext. 7421

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil + Cognitive remediation therapy (CRT)

Combination Product

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.

Donepezil + Placebo CRT

Combination Product

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.

Placebo medication + Cognitive remediation therapy (CRT)

Combination Product

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.

Placebo medication + Placebo CRT

Combination Product

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 outcomes

  1. Heavy drinking days

    Time frame: 13 weeks of active intervention

    Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)

Secondary outcomes

  1. Global neurocognitive functioning

    Time frame: At 7 weeks and at 13 weeks

    Global neurocognitive functioning on a global index of neurocognitive function

Study contacts

Contact information is provided by the study sponsor or research team.

Gihyun Yoon, MD

CONTACT

[email protected]

203-932-5711 ext. 7421

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2021
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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