Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

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.

Conditions

• Alcohol Use Disorder

Interventions

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.

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• VA Connecticut Healthcare System

  lead FED

Principal Investigators

• Gihyun Yoon, MD · Yale University, VA Connecticut Healthcare System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-08

Primary Completion

2027-05-31

Completion

2027-05-31

FDA Drug

Yes

Countries

• United States

Study Locations