Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042102
• Other study ID #: GY0010
• Secondary ID: 5R01AA029075
• Status: Recruiting
• Phase: Phase 2
• Start date: August 8, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2023
• Source: VA Connecticut Healthcare System
• Contact: Gihyun Yoon, MD
• Phone: 203-932-5711
• Email: gihyun.yoon[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. Last alcohol use and at least one heavy drinking day within the past 30 days

5. Willingness to attend follow-up assessments at 13 weeks

6. Willingness to submit to 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 unlikely

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Combination Product:
• Donepezil + Cognitive remediation therapy (CRT)
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.
• Donepezil + Placebo CRT
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.
• Placebo medication + Cognitive remediation therapy (CRT)
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.
• Placebo medication + Placebo CRT
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.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heavy drinking days	Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)	13 weeks of active intervention
Secondary	Global neurocognitive functioning	Global neurocognitive functioning on a global index of neurocognitive function	At 7 weeks and at 13 weeks