Меню
Идёт набор NCT07171359

TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)

Без фазы С лечением Alcohol Use Disorder Opioid Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TMS Low-Dose, TMS High-Dose.
Кому может быть актуально
Состояния в реестре: Alcohol Use Disorder, Opioid Use Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Transcranial Magnetic Stimulation (TMS) to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)

Обзор

The study aims to explore the potential of Transcranial Magnetic Stimulation (TMS), particularly Theta Burst Stimulation (TBS), as an adjunctive treatment to enhance recovery outcomes (consumption and craving; withdrawal symptoms; mental, physical, sleep, and cognitive health; engagement with therapy, etc.) in individuals with Opioid Use Disorder (OUD) and individuals with Alcohol Use Disorder (AUD). This project will be completed in partnership with Another Chance Rehab (Portland): Portland's top addiction treatment program offering evidence-based treatment programs for a range of substance use disorders. Another Chance Rehab will serve as the project site for this work.

Подробное описание

The investigators will conduct a prospective, randomized, controlled trial. To identify which TMS protocol is most efficacious, there will be three arms to this study.

1. Treatment as Usual (TAU): Participants complete their regularly scheduled therapy activities and receive no add-on TMS. They will answer the demographic survey and outcome measure surveys (listed in a later section). 2. TAU + 3-minute TMS: Participants complete TAU as described above, with one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total). 3. TAU + 9-minute TMS: Participants complete TAU as described above, with one 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Вмешательства

  • Устройство TMS Low-Dose
    one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
  • Устройство TMS High-Dose
    One 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Первичные конечные точки

  • Engagement in Treatment As Usual activities [Срок оценки: 4 weeks]
  • Engagement in Treatment As Usual Activities [Срок оценки: 4 weeks]
  • Engagement in Treatment As Usual Activities [Срок оценки: 4 weeks]
  • Engagement in Treatment As Usual Activities [Срок оценки: 4 weeks]
Вторичные конечные точки (5)
  • Delay Discounting [Срок оценки: 4 weeks]
  • Go/No-Go Task [Срок оценки: 4 weeks]
  • Balloon Analogue Risk Task [Срок оценки: 4 weeks]
  • Barratt Impulsiveness Scale-11 [Срок оценки: 4 weeks]
  • Sensation Seeking Scale [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • 18+ years old
  • Enrolled in the Intensive Outpatient Program at Another Chance Drug \& Alcohol Rehab Center of Portland, Portland, OR.
  • Diagnosed with Opioid Use Disorder
  • Diagnosed with Alcohol Use Disorder

Критерии исключения

  • Children <18 years old
  • Pregnant
  • Non-English speaking
  • Currently taking prescription benzodiazepines or anti-convulsive medications
  • In active alcohol or opioid withdrawal
  • History of seizure disorder diagnosis
  • History of Schizophrenia, Bipolar Disorder, Mania

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Another Chance Drug & Alcohol Rehab Center of Portland — Portland

Публикации

  • Liu X, Zhao X, Liu T, Liu Q, Tang L, Zhang H, Luo W, Daskalakis ZJ, Yuan TF. The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder. EBioMedicine. 2020 Jun;56:102809. doi: 10.1016/j.ebiom.2020.102809. Epub 2020 Jun 5. PMID 32512513
  • Bormann NL, Oesterle TS, Arndt S, Karpyak VM, Croarkin PE. Systematic review and meta-analysis: Combining transcranial magnetic stimulation or direct current stimulation with pharmacotherapy for treatment of substance use disorders. Am J Addict. 2024 May;33(3):269-282. doi: 10.1111/ajad.13517. Epub 2024 Jan 25. PMID 38273429
  • Tsai TY, Wang TY, Liu YC, Lee PW, Chang WH, Lu TH, Tseng HH, Lee SY, Chang YH, Yang Y, Chen PS, Chen KC, Yang YK, Lu RB. Add-on repetitive transcranial magnetic stimulation in patients with opioid use disorder undergoing methadone maintenance therapy. Am J Drug Alcohol Abuse. 2021 May 4;47(3):330-343. doi: 10.1080/00952990.2020.1849247. Epub 2021 Jan 10. PMID 33426970

Идентификаторы

NCT: NCT07171359 · TMS4OUDAUD · RECOVERYWORKSNWTMS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗