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Recruiting NCT05042102

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Phase II Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Donepezil + Cognitive remediation therapy (CRT), Donepezil + Placebo CRT, Placebo medication + Cognitive remediation therapy (CRT), Placebo medication + Placebo CRT.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Combination product Donepezil + Cognitive remediation therapy (CRT)
    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.
  • Combination product Donepezil + Placebo CRT
    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.
  • Combination product Placebo medication + Cognitive remediation therapy (CRT)
    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.
  • Combination product Placebo medication + Placebo CRT
    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 outcome measures

  • Heavy drinking days [Time frame: 13 weeks of active intervention]
Secondary outcome measures (1)
  • Global neurocognitive functioning [Time frame: At 7 weeks and at 13 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Connecticut Healthcare System — West Haven

Publications

  • Yoon G, Sofuoglu M, Petrakis IL, Pittman B, Bell MD. The combination of donepezil and cognitive training for improving treatment outcomes for alcohol use disorder: Design of a randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107657. doi: 10.1016/j.cct.2024.107657. Epub 2024 Aug 5. PMID 39111388

Identifiers

NCT: NCT05042102 · GY0010 · 5R01AA029075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗