NCT05042102

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: VA Connecticut Healthcare System · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-08-08
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2021-09-13
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study