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Идёт набор NCT06432465

tDCS to Decrease Opioid Relapse (UH3)

Без фазы С лечением 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: active tDCS, sham tDCS.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder. Базовые параметры: 21 лет — 60 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
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Обзор

Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.

Подробное описание

Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Participants will be assessed three times using electroencephalographic (EEG), once prior to tDCS+CCN priming, right after the completion of 5 sessions of tDCS+CCN priming (one week later), and again 10 weeks later.

This phase will address long-term (3- and 6-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 24 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on \>4 days per month and having an opioid positive urine screen), as well as days of opioid use.

Вмешательства

  • Устройство active tDCS
    The anode will be placed over the right DLPFC (F4 on the EEG 10-20 system) and the cathode over the left DLPFC65 (F3) using 25cm2 sponges at an intensity of 2mA. Stimulation will be delivered for 20 minutes via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus).
  • Устройство sham tDCS
    Same device and procedures as active tDCS with the exception that the device includes a study mode, in which subject-specific codes are entered to deliver active or sham stimulation, keeping the administrator blinded. Sham stimulation will use a method in which stimulation will be ramped up and back down over a 30-second period at the beginning and end of sham tDCS.

Первичные конечные точки

  • Opioid Craving [Срок оценки: 2 weeks]
Вторичные конечные точки (2)
  • EEG theta activity [Срок оценки: 2 weeks]
  • opioid relapse [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

  • current opioid dependence
  • between 21-60 years of age
  • recent initiation of buprenorphine or methadone (≤90 days)
  • enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.

Критерии исключения

  • current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)
  • bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder
  • current suicidality
  • evidence of significant neurocognitive dysfunction
  • conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals
  • probation/parole requirements or an upcoming move that might interfere with protocol participation
  • planning to terminate buprenorphine or methadone in less than 3 months
  • current pregnancy or plan to become pregnant in the next month.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Butler Hospital — Providence

Идентификаторы

NCT: NCT06432465 · 1317333 · 4UH3DA047793

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗