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

Last updated: March 19, 2020
Sponsor: VA Connecticut Healthcare System
Overall Status: Completed

Phase

2/3

Condition

Alcohol Use Disorder

Substance Abuse

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT04318639
MB0020
  • Ages 21-80
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 useaccording 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 SDbelow standard norms on at least 1 key neurocognitive MCI related variable (Learningand Memory, Delayed Recall, Executive Function, Working Memory).

Exclusion

Exclusion Criteria:

  • Lifetime diagnosis of a psychotic disorder, not induced by drug use.

  • Current prescribed treatment of opioids or benzodiazepines, which may affect newlearning Involvement in a legal case that may lead to incarceration during studyperiod

  • 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 interferewith cognitive training.

  • Pre-morbid IQ estimate below 70.

  • Unstable housing or lack of commitment to staying within a geographic area that wouldmake follow-up possible.

  • Unwillingness to provide contact information of someone who can help study staffcontact the participant in the event that study staff are unable to maintain contactdirectly.

  • Allergy to Donepezil.

  • Unstable cardiovascular disease or unstable medical condition-clinically determined bya physician.

  • Imminent suicidal or homicidal risk.

  • Pregnant or nursing women, positive pregnancy test, or inadequate birth controlmethods in women of childbearing potential.

Study Design

Total Participants: 15
Study Start date:
August 17, 2018
Estimated Completion Date:
December 31, 2019

Study 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 cognitive remediation therapy (CRT) with work therapy have shown efficacy with newly recovering Veterans with AUD compared with work therapy alone. The current study combines Donepezil and CRT in an open-label trial to learn whether the combination of Donepezil + CRT may improve neurocognitive functioning and decrease 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 provide 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. Primary outcome variables will be a Clinical Global Index of AUD recovery and a Global Cognitive Composite of MCI related neurocognitive assessment.

Connect with a study center

  • VA Connecticut Healthcare System

    West Haven, Connecticut 06516
    United States

    Site Not Available

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