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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Donepezil + Cognitive remediation therapy (CRT)
Combination productSubjects 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 productSubjects 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 productSubjects 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 productSubjects 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.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: Donepezil + Cognitive remediation therapy (CRT)Experimental treatment 1 intervention
Group B: Donepezil + Placebo CRTExperimental treatment 1 intervention
Group C: Placebo medication + Cognitive remediation therapy (CRT)Experimental treatment 1 intervention
Group D: Placebo medication + Placebo CRTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Heavy drinking days
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
Time frame
13 weeks of active interventionSecondary outcomes
1
Global neurocognitive functioning
Global neurocognitive functioning on a global index of neurocognitive function
Time frame
At 7 weeks and at 13 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Connecticut Healthcare System
Lead sponsor
Yale University
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov