Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

VA Connecticut Healthcare System

Status and phase: Enrolling; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Combination Product: Placebo medication + Placebo CRT; Combination Product: Placebo medication + Cognitive remediation therapy (CRT); Combination Product: Donepezil + Placebo CRT; Combination Product: Donepezil + Cognitive remediation therapy (CRT)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT05042102

GY0010

5R01AA029075 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups

Donepezil + Cognitive remediation therapy (CRT)

Experimental group

Description:

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.

Treatment:

Combination Product: Donepezil + Cognitive remediation therapy (CRT)

Donepezil + Placebo CRT

Experimental group

Description:

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.

Treatment:

Combination Product: Donepezil + Placebo CRT

Placebo medication + Cognitive remediation therapy (CRT)

Experimental group

Description:

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.

Treatment:

Combination Product: Placebo medication + Cognitive remediation therapy (CRT)

Placebo medication + Placebo CRT

Experimental group

Description:

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.

Treatment:

Combination Product: Placebo medication + Placebo CRT