Alcohol Use Disorder
Conditions
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.
Interventions
COMBINATION_PRODUCTDonepezil + Cognitive remediation therapy (CRT)
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.
COMBINATION_PRODUCTDonepezil + Placebo CRT
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.
COMBINATION_PRODUCTPlacebo medication + Cognitive remediation therapy (CRT)
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.
COMBINATION_PRODUCTPlacebo medication + Placebo CRT
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.
Sponsors
VA Connecticut Healthcare System
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heavy drinking days | 13 weeks of active intervention | Heavy drinking days as measured by weekly Time Line Follow Back (TLFB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global neurocognitive functioning | At 7 weeks and at 13 weeks | Global neurocognitive functioning on a global index of neurocognitive function |
Countries
United States
Contacts
CONTACTGihyun Yoon, MD
PRINCIPAL_INVESTIGATORGihyun Yoon, MD
Yale University, VA Connecticut Healthcare System
Outcome results
None listed