OUD (Opioid Use Disorder) Target Trial

Официальное название

The Development and Validation of Neural Targets in Opioid Use Disorder

Обзор

In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids. The investigators are trying to learn two things: 1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine? 2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS? In order to complete the study the investigators will ask participants to: * Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later. * Undergo study-treatment with 30-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks. * Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.

Вмешательства

• Устройство Active repetitive Transcranial Magnetic Stimulation (rTMS)
  Active rTMS will be delivered with a MagVenture MagPro X100 rTMS device with a Cool-B65-AP coil. rTMS will be applied to a personalized treatment target within the Left-Dorsolateral Prefrontal Cortex using a Localite Neuronavigation device.
• Устройство Sham repetitive Transcranial Magnetic Stimulation (rTMS)
  Sham rTMS in an identical fashion to the active-rTMS condition will be delivered via the built-in e-sham system in the MagVenture device.
• Диагностический тест High Ventral Striatal Reactivity
  We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define high ventral striatal reactivity as having \>mean voxels in the ventral striatum activate
• Диагностический тест Low Ventral Striatal Reactivity
  We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \<mean voxels in the ventral striatum activate

Первичные конечные точки

• Number of participants with Relapse Free survival [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (1)

• Weeks of opioid abstinance [Срок оценки: 12-weeks]

Критерии участия

Критерии включения

• Age 18 or older; all genders included.
• Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
• Meet DSM-5 criteria for moderate or severe OUD. Individuals may also meet criteria for another substance use disorder (with the exception of alcohol or sedative/hypnotic); but must identify opioids as their primary substance.
• Starting buprenorphine and planning on opioid abstinence

Критерии исключения

• Pregnant, breast-feeding, or planning on getting pregnant.
• Alcohol or sedative/hypnotic use disorders (seizure risk).
• History of/or current psychotic disorder (e.g. schizophrenia).
• Current or lifetime bipolar disorder.
• Unstable Axis-I condition requiring starting a new medication.
• Active suicidal ideation / suicide attempt within 90 days.
• History of/or current dementia or other cognitive impairment.
• Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
• Unstable general medical conditions.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Duke University — Durham

Идентификаторы

NCT: NCT06585709 · Pro00116151

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗