Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Phase 2

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Combination Product: Donepezil + Cognitive remediation therapy (CRT); Combination Product: Placebo medication + Cognitive remediation therapy (CRT); Combination Product: Donepezil + Placebo CRT; Combination Product: Placebo medication + Placebo CRT

• Registration Number: NCT05042102
• Lead Sponsor: VA Connecticut Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Study Start: 2022-08-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donepezil + Cognitive remediation therapy (CRT)	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.
Placebo medication + Cognitive remediation therapy (CRT)	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.
Donepezil + Placebo CRT	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 + Placebo CRT	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.

Primary Outcome Measures

Name	Time	Method
Heavy drinking days	13 weeks of active intervention	Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)

Secondary Outcome Measures

Name	Time	Method
Global neurocognitive functioning	At 7 weeks and at 13 weeks	Global neurocognitive functioning on a global index of neurocognitive function

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States