Clinical trial NCT05042102: Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
Official title: The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
Collaborators: name: Yale University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-09-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Heavy drinking days
timeFrame: 13 weeks of active intervention
Secondary outcomes:
measure: Global neurocognitive functioning
timeFrame: At 7 weeks and at 13 weeks
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University, VA Connecticut Healthcare System
name: Gihyun Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: