The combination of donepezil and cognitive training for improving treatment outcomes for alcohol use disorder: Design of a randomized controlled trial.

Autor: Yoon G; VA Connecticut Healthcare System, West Haven, CT, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. Electronic address: gihyun.yoon@yale.edu., Sofuoglu M; VA Connecticut Healthcare System, West Haven, CT, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Petrakis IL; VA Connecticut Healthcare System, West Haven, CT, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Pittman B; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Bell MD; VA Connecticut Healthcare System, West Haven, CT, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Oct; Vol. 145, pp. 107657. Date of Electronic Publication: 2024 Aug 05.
DOI: 10.1016/j.cct.2024.107657
Abstrakt: Background: The development of alcohol use disorder (AUD) is a major concern in public health, and cognitive impairments caused by alcohol are involved in this process. Emerging neurobiological evidence suggests that donepezil, an anticholinesterase agent, may improve AUD treatment outcomes by enhancing neurocognitive functioning. Previous research has also suggested that cognitive remediation therapy (CRT) could potentially improve cognitive function and AUD treatment outcomes. We present the rationale and design of a trial to evaluate the combination of donepezil and cognitive remediation therapy (donepezil + CRT) as an intervention for AUD.
Methods: We propose a 13-week, randomized, double-blind, placebo-controlled, between-subjects trial comparing 4 groups (donepezil + CRT vs. donepezil alone vs. CRT alone vs. placebos) as an intervention for AUD. The main goal of the study is to evaluate if donepezil + CRT is superior to placebo in reducing heavy drinking days and improving neurocognitive functioning. A total of 160 patients (4 groups, 40 per each group) with AUD between the ages of 18-80 years will be recruited at Yale University and the VA Connecticut Healthcare System. Primary outcome measures include 1) heavy drinking by Timeline Follow Back (TLFB) over 13 weeks and 2) global neurocognitive functioning by a global index of neurocognitive function score at 7 and 13 weeks.
Discussion: This protocol paper describes the rationale and proposed methods for the randomized controlled trial for improving AUD treatment outcomes. This project has significant clinical potential to help patients suffering from AUD by improving their cognition and reducing alcohol consumption.
Trial Registration: NCT05042102.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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