rTMS as Add on Treatment for Substance Use Disorders

Обзор

This pilot study is designed to test feasibility and superiority of rTMS types and target locations for the optimal rTMS intervention for individuals seeking treatment for Alcohol Use Disorder (AUD) or Opioid Use Disorder (OUD). The critical questions this study seeks to answer are: which rTMS type applied to l-dlPFC in OUD participants will induce the greatest reduction of opioid use post-treatment? Is inhibitory rTMS applied to medial prefrontal cortex (mPFC) more effective than excitatory rTMS applied to l-dlPFC at reducing alcohol use post treatment in AUD participants?

Подробное описание

Aim 1: To assess feasibility of applying rTMS within a residential treatment center. Feasibility will be assessed by 1) recruitment of sufficient numbers of AUD and OUD participants; 2) completion of the rTMS intervention; 3) retention of follow-up at the 4-week interval.

Aim 2: To assess superiority of mPFC cTBS compared to l-dlPFC iTBS to reduce alcohol use in AUD patients post-treatment. Superiority will be assessed by evaluating 1) treatment engagement at the 4-week interval (e.g., number of prescribed AUD treatments addended); 2) reduction of drinks/day post-treatment, compared to pre-treatment; 3) reduction of heavy drinking days (e.g., \>5 drinks/day) post-treatment, compared to pre-treatment.

Aim 3: To assess superiority of l-dlPFC iTBS to l-dlPFC cTBS to reduce opioid use in OUD patients post-treatment. Superiority will be assessed by evaluating 1) treatment engagement at the 4-week interval (e.g., number of prescribed OUD treatments addended); 2) reduction of opioids used post-treatment, compared to pre-treatment.

Вмешательства

• Устройство repetitive transcranial magnetic stimulation (rTMS) for AUD
  Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. To administer TMS, a stimulator equipped with a figure-8 coil will be used. Two separate coils will be used that are similar in appearance and acoustic properties. One active, unblinded, coil will be used to determine resting motor threshold (RMT) and deliver pulses for the recrui
• Устройство repetitive transcranial magnetic stimulation (rTMS) for OUD
  Description: Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. To administer TMS, a stimulator equipped with a figure-8 coil will be used. Two separate coils will be used that are similar in appearance and acoustic properties. One active, unblinded, coil will be used to determine resting motor threshold (RMT) and deliver pulses f

Первичные конечные точки

• Number of participants that successfully complete the study [Срок оценки: 4-weeks post-treatment]
• Mean number of drinks per day [Срок оценки: 4-weeks post-treatment]
• Mean number of heavy drinking days [Срок оценки: 4-weeks post-treatment]
• Opioid use [Срок оценки: 4-weeks post-treatment]

Критерии участия

Критерии включения

• Be able to give valid informed consent in English.
• Absence of cognitive impairment: IQ equivalent of ≥ 70 on the WRAT.
• Receiving treatment for either AUD or OUD

Критерии исключения

• History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month.
• Current meeting withdrawal criteria for alcohol: AUD participants will not meet for clinically significant alcohol withdrawal: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) ≤ 5.
• First-degree family history of epilepsy or multiple sclerosis.
• Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes rTMS administration.
• Current use of anti- or pro-convulsive action.
• Use of benzodiazepines in the last 48 hours prior to rTMS. Benzodiazepines are used during alcohol withdrawal management but then are discontinued prior to recruitment into the study. Therefore, rTMS eligible participants will not continue taking benzodiazepines.
• Lifetime history of schizophrenia, bipolar disorder, mania.
• History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
• Pregnant or lactating women.
• TMS contraindications.
• Treatment center discharge date does not allow for scheduling of all 5 rTMS days

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

• Hartford Healthcare — Hartford

Идентификаторы

NCT: NCT06963476 · Steele 042225 · HHC-2025-0073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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