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Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Donepezil + Cognitive remediation therapy (CRT)
Donepezil + Placebo CRT
Placebo medication + Cognitive remediation therapy (CRT)
Placebo medication + Placebo CRT
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females 18-80 years of age
  2. Fluency in English and a 6th grade or higher reading level
  3. 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)
  4. Referred for the study within 30 days of detoxification or last alcohol use according to medical records
  5. Willingness to attend follow-up assessments at 13 weeks
  6. Willingness to submit to Breathalyzer screenings and Urine Toxicology screenings

Exclusion Criteria:

  1. Lifetime diagnosis of a psychotic disorder, not induced by drug use
  2. Current treatment with opioids or benzodiazepines, which may affect new learning
  3. Involvement in a legal case that may lead to incarceration during the study period
  4. Residential plans that would interfere with participation
  5. Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)
  6. An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
  7. Pre-morbid intelligence quotient (IQ) estimate below 70
  8. Unstable housing or lack of commitment to staying within a geographic area that would make follow-up possible
  9. 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
  10. Allergy to donepezil
  11. Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
  12. Imminent suicidal or homicidal risk
  13. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential

Sites / Locations

  • VA Connecticut Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Donepezil + Cognitive remediation therapy (CRT)

Donepezil + Placebo CRT

Placebo medication + Cognitive remediation therapy (CRT)

Placebo medication + Placebo CRT

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Heavy drinking days
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)

Secondary Outcome Measures

Global neurocognitive functioning
Global neurocognitive functioning on a global index of neurocognitive function

Full Information

First Posted
September 3, 2021
Last Updated
April 13, 2023
Sponsor
VA Connecticut Healthcare System
Collaborators
Yale University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05042102
Brief Title
Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
Official Title
The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
Collaborators
Yale University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donepezil + Cognitive remediation therapy (CRT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Donepezil + Placebo CRT
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo medication + Cognitive remediation therapy (CRT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo medication + Placebo CRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Donepezil + Cognitive remediation therapy (CRT)
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Donepezil + Placebo CRT
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo medication + Cognitive remediation therapy (CRT)
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo medication + Placebo CRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heavy drinking days
Description
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
Time Frame
13 weeks of active intervention
Secondary Outcome Measure Information:
Title
Global neurocognitive functioning
Description
Global neurocognitive functioning on a global index of neurocognitive function
Time Frame
At 7 weeks and at 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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) Last alcohol use and at least one heavy drinking day within the past 30 days 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gihyun Yoon, MD
Phone
203-932-5711
Ext
7421
Email
gihyun.yoon@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Organizational Affiliation
Yale University, VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Phone
203-932-5711
Ext
7421
Email
gihyun.yoon@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

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