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

March 19, 2020 updated by: Morris Bell, VA Connecticut Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donepazil+CRT
Combination product: Donepazil

Donepezil: Subjects will take 5 mg/day of donepezil in the evening for first 4 weeks, then 10 mg/day of donepezil in the evening until week 13.

Cognitive remediation therapy (CRT): This study employs a computerized program (BrainHQ) for cognitive enhancement. Participants use their program for one hour per session, up to five sessions per week, over 13 weeks (maximum of 65 sessions). They may training on site or at another quiet location of their choice.

Other Names:
  • Cognitive Remediation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Index of AUD recovery
Time Frame: 13 weeks
7-point likert scale of recovery
13 weeks
Global Composite T-Score of MCI related neurocognitive measures.
Time Frame: 13-week
Measures of Learning and memory, delayed recall, working memory and executive. Higher scores indicate better functioning
13-week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability of Interventions
Time Frame: 13 weeks
Adverse events
13 weeks
Adherence to Donepezil
Time Frame: 13 weeks
Percentage of Donepezil compliance based on weekly pill counts
13 weeks
Adherence to CRT
Time Frame: 13 weeks
Percentage of training sessions completed out of 65 possible sessions
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Investigators

  • Principal Investigator: Morris Bell, VA Connecticut Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only those already identified in HIPAA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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