Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Last updated: November 7, 2023
Sponsor: VA Connecticut Healthcare System
Overall Status: Active - Recruiting

Phase

2

Condition

Alcohol Use Disorder

Alcohol Dependence

Substance Abuse

Treatment

Donepezil + Cognitive remediation therapy (CRT)

Placebo medication + Placebo CRT

Placebo medication + Cognitive remediation therapy (CRT)

Clinical Study ID

NCT05042102
GY0010
5R01AA029075
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 acurrent 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

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 interferewith 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 wouldmake follow-up unlikely
  9. Unwillingness to provide contact information of someone who can help study staffcontact the subjects in the event that study staff are unable to maintain contactdirectly
  10. Allergy to donepezil
  11. Unstable cardiovascular disease or unstable medical condition-clinically determined bya physician
  12. Imminent suicidal or homicidal risk
  13. Pregnant or nursing women, positive pregnancy test, or inadequate birth controlmethods in women of childbearing potential

Study Design

Total Participants: 160
Treatment Group(s): 4
Primary Treatment: Donepezil + Cognitive remediation therapy (CRT)
Phase: 2
Study Start date:
August 08, 2022
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • VA Connecticut Healthcare System

    West Haven, Connecticut 06516
    United States

    Active - Recruiting

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