Status:
COMPLETED
The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
Lead Sponsor:
VA Connecticut Healthcare System
Conditions:
Alcohol Use Disorder
Mild Cognitive Impairment
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
PHASE3
Brief Summary
This is an open label feasibility trial to learn whether the combination of donepezil and cognitive remediation therapy (Donepezil + CRT) may improve neurocognitive functioning and decreasing alcohol ...
Detailed Description
Donepezil is FDA approved for treatment of dementia and recent animal studies have suggested that it may reduce craving in rat models of alcohol use disorder. Investigators' previous studies of cognit...
Eligibility Criteria
Inclusion
- Males and females 21-80 years of age
- Fluency in English and a 6th grade or higher reading level
- Meets DSM-V criteria for a current Alcohol Use Disorder
- Referred for the study within 30 days of detoxification or last substance use according to medical records
- Willingness to attend follow-up assessments at 13 weeks
- Willingness to submit to Breathalyzer screenings and Urine Toxicology screenings.
- Meets MCI criteria with greater than 1.5 SD below pre-morbid IQ estimate or 1.5 SD below standard norms on at least 1 key neurocognitive MCI related variable (Learning and Memory, Delayed Recall, Executive Function, Working Memory).
Exclusion
- Lifetime diagnosis of a psychotic disorder, not induced by drug use.
- Current prescribed treatment of opioids or benzodiazepines, which may affect new learning Involvement in a legal case that may lead to incarceration during 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 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 participant in the event that study staff are unable to maintain contact directly.
- Allergy to Donepezil.
- Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician.
- Imminent suicidal or homicidal risk.
- Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential.
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04318639
Start Date
August 17 2018
End Date
December 31 2019
Last Update
March 24 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516