Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Phase 2RecruitingNCT05042102

VA Connecticut Healthcare System160 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Alcohol Use Disorder

Interventions

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 CRTCOMBINATION_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 a current 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 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 interfere with 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 would make follow-up unlikely 9. 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 10. Allergy to donepezil 11. Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician 12. Imminent suicidal or homicidal risk 13. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential

Locations (1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Heavy drinking days

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

Time frame: 13 weeks of active intervention

Secondary Outcomes

Global neurocognitive functioning

Global neurocognitive functioning on a global index of neurocognitive function

Time frame: At 7 weeks and at 13 weeks

Central Contacts

Gihyun Yoon, MD

CONTACT

203-932-5711 gihyun.yoon@yale.edu

Data from ClinicalTrials.gov

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