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临床试验/NCT03969251
NCT03969251已完成不适用

Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation

Nassima Ait-Daoud Tiouririne2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年7月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
List Sorting Working Memory Test (LSWMT)

研究概览

简要总结

This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.

详细描述

This is a randomized double- blind, control study.

To test the hypothesis, the investigator propose a 2 phase design:

Phase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes.

This study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks.

Participant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right handed males and females who have given written informed consent.
  • Age 22 years and above with a history of alcohol use disorder
  • Good physical health
  • Have a current diagnosis of alcohol use disorder
  • Reports at least 4 "heavy drinking days" on average in the past 30 days.
  • Have a BAC by breathalyzer equal to 0.000 when the participants signed the informed consent document
  • Six months stability on any psychotropic medications
  • Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
  • Be able to provide written informed consent, able to understand written and oral instructions in English and be able to complete the questionnaires required by the protocol.

排除标准

  • Please contact site for additional information.

研究组 & 干预措施

Transcranial Magnetic Stimulation (rTMS)

Experimental

repetitive transcranial magnetic stimulation

干预措施: Transcranial Magnetic Stimulation (rTMS) (Device)

Sham (SS)

Sham Comparator

repetitive sham rTMS

干预措施: Sham (SS) (Device)

结局指标

主要结局

List Sorting Working Memory Test (LSWMT)

时间窗: Up to 5 months

This is a neuropsychological task that measures working memory.

Flanker Inhibitory Control and Attention Test (FICAT)

时间窗: Up to 5 months

This is a neuropsychological task that measures attention and inhibitory control.

Wisconsin Card Sorting Test (WCST)

时间窗: Up to 5 months

This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.

Dimensional Change Card Sort Task (DCCST)

时间窗: Up to 5 months

This is a neuropsychological task that measures cognitive flexibility and attention.

次要结局

  • Percentage of Days of Abstinence(Up to 5 months)
  • Percentage of Heavy Drinking Days(Up to 5 months)
  • Drinks Per Drinking Day(Up to 5 months)
  • Alcohol Craving Questionnaire (ACQ-NOW)(Up to 5 months)

研究者

发起方
Nassima Ait-Daoud Tiouririne
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nassima Ait-Daoud Tiouririne

Associate Professor, Director of UVA Center for Leading Edge Addiction Research

University of Virginia

研究点 (2)

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