Transcranial Magnetic Stimulation for Adolescents and Young Adults With Cannabis Use Disorder

Обзор

This pilot study will investigate the potential of repetitive transcranial magnetic stimulation (rTMS) to strengthen a neural circuit critical for maintaining abstinence in adolescents and youth with cannabis use disorder (CUD).

Вмешательства

• Устройство Magstim SuperRapid2
  Intermittent burst stimulation (iTBS) bursts of 3 pulses at 30 Hz repeated every 200ms for 2 s (1 train), trains repeat every 10s apart (8s inter-burst interval between trains), 600 total pulses, 70% RMT (190 sec duration)
• Устройство Sham rTMS
  All sham participants will be exposed to the same procedures as the active rTMS condition but using the sham air-cooled coil. The sham coil looks and sounds the same as the active coil but it has a shield in it that blocks the magnetic field (so it is not stimulating the brain at all).

Первичные конечные точки

• Feasibility, tolerability, and acceptability of rTMS [Срок оценки: Month 4]
• rTMS effects on neural target engagement [Срок оценки: Month 4]
• Changes in CUD recovery metrics [Срок оценки: Month 4]

Критерии участия

Критерии включения

• 15-21 years old
• For minors, parent/legal guardian able to provide consent and child able to provide assent; for adults, ability to self-consent per MacArthur Competence Assessment Tool for Clinical Research
• Ability to comply with study procedures
• Treatment-seeking youth diagnosed with CUD as per the Mini-International Neuropsychiatric Interview (MINI-KID (Sheehan et al., 2010) for 15-17 years old and MINI (Sheehan et al., 1998) for 18-21 years old)
• Cannabis use 3+ days per week (or 12+ days in the past month) as verified by Timeline Followback (TLFB) (Sobell \& Sobell, 1996)
• Fluent in spoken English

Критерии исключения

• Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, intracranial lesions, epilepsy or seizure disorders, or individuals with a family history of epilepsy or seizure in a first degree relative, traumatic brain injury, brain tumor, stroke, neurocardiogenic syncope, mania/bipolar disorder, implanted medical devices or metallic objects in the head, current pregnancy or not using effective contraception if capable of becoming pregnant, or any other serious medical condition or contraindication as judged by the study physician; moderate to severe heart disease, pediatric populations with risk factors for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturation, or posture)
• Inability to undergo MRI.
• Diagnosis of psychosis, cognitive disability or active suicidality. The MINI (Sheehan et al., 1998, 2010) will be used to assess current psychiatric comorbidities and the Ask Suicide-Screening Questions (ASQ) will be used to assess suicidality (Horowitz et al., 2012).
• Primary current alcohol or substance use disorder, except for caffeine or nicotine.
• Taking a medication with high seizurogenic potential (e.g., clomipramine, tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, anti-psychotics, lithium, bupropion -e.g. Wellbutrin). Participants taking psychotropic medications will be included if dose is stable for ≥4 weeks with no anticipated changes during the study period. All concurrent treatments will be monitored during the study period.

• If an individual is currently taking antibiotics that affect the central nervous system such as Fluoroquinolones (Ciprofloxacin, Levofloxacin, Moxifloxacin) or Imipenem, medications that have the potential of lowering seizure threshold, participation in the study will be delayed until 5 days after the last antibiotic dose.
• If an individual is taking antihistamines (i.e. Benadryl/diphenhydramine), they will be asked to refrain from using the antihistamine for at least 24 hours before the TMS session. If the participant is not able to do so, they will be excluded from the study.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT07634835 · PSYCH-2026-33908

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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