The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder

Completed · Phase 2/Phase 3

Conditions studied: Alcohol Use Disorder, Mild Cognitive Impairment

In brief

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 use in Veterans with alcohol use disorder who have mild cognitive impairment (AUD-MCI). The study will determine the acceptability and adherence to treatment and preliminary evidence for efficacy. The study will recruit 15 newly recovering Veterans individuals with AUD-MCI for a 13-week, open-label, single-arm pilot study with sobriety and cognitive assessments at baseline and at 13-week follow-up.

Key facts

Study ID

NCT04318639

Run by

VA Connecticut Healthcare System

People needed

15

Starts

2018-08-17

Expected to finish

2019-12-31

Last updated by the study team

2020-03-24

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• VA Connecticut Healthcare System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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