Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Donepezil + 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 Product: Donepezil + 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.
|
| Experimental: Donepezil + 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 Product: Donepezil + 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.
|
| Experimental: Placebo 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 Product: Placebo 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.
|
| Experimental: Placebo 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. |
Combination Product: Placebo 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.
|
Outcome Measures
Primary Outcome Measures
- Heavy drinking days [13 weeks of active intervention]
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
Secondary Outcome Measures
- Global neurocognitive functioning [At 7 weeks and at 13 weeks]
Global neurocognitive functioning on a global index of neurocognitive function
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
-
Referred for the study within 30 days of detoxification or last alcohol use according to medical records
-
Willingness to attend follow-up assessments at 13 weeks
-
Willingness to submit to Breathalyzer screenings and Urine Toxicology screenings
Exclusion Criteria:
-
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
-
Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)
-
An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
-
Pre-morbid intelligence quotient (IQ) estimate below 70
-
Unstable housing or lack of commitment to staying within a geographic area that would make follow-up possible
-
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
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Allergy to donepezil
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Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
-
Imminent suicidal or homicidal risk
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Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Connecticut Healthcare System | West Haven | Connecticut | United States | 06516 |
Sponsors and Collaborators
- VA Connecticut Healthcare System
- Yale University
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Gihyun Yoon, MD, Yale University, VA Connecticut Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GY0010