Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVA Connecticut Healthcare System
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Donepezil + Cognitive remediation therapy (CRT)
- Donepezil + Placebo CRT
- Placebo medication + Cognitive remediation therapy (CRT)
- Placebo medication + Placebo CRT
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
VA Connecticut Healthcare System
Lead sponsor
Yale University
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov