Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Conditions

• Alcohol Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Donepezil + Cognitive remediation therapy (CRT) — COMBINATION_PRODUCT
  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 — COMBINATION_PRODUCT
  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) — COMBINATION_PRODUCT
  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 — COMBINATION_PRODUCT
  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.

Study Details

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.

Key Dates

Start date

Aug 8, 2022

Status verified

Sep 2025

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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 Measure

Heavy drinking days [ Time Frame: 13 weeks of active intervention ]

Central Contacts

• Gihyun Yoon, MD
  203-932-5711
  [email protected]

Locations (1)

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