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Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Sponsor: University of Utah
Summary
The goal of this clinical trial is to learn whether transcranial magnetic stimulation, also called TMS, is a practical and acceptable treatment option for methamphetamine use disorder during pregnancy. The study will enroll pregnant women who have methamphetamine use disorder. The main questions it aims to answer are: 1. Can pregnant women with methamphetamine use disorder be successfully enrolled and complete TMS treatment? 2. Is TMS acceptable to pregnant participants, their caregivers or partners, and clinicians involved in their care? 3. Is it feasible to collect maternal and infant health information during pregnancy and after delivery? Researchers will compare standard 4-week TMS, accelerated 2-week TMS, and treatment as usual to see which approach is more practical and better tolerated during pregnancy. Participants will: * Be randomly assigned to receive standard TMS, accelerated TMS, or treatment as usual. * Complete study visits during pregnancy and follow-up visits after treatment. * Complete questionnaires about substance use, cravings, mood, anxiety, sleep, quality of life, and side effects. * Provide urine drug tests and have vital signs and safety assessments completed. * Allow the study team to review pregnancy and infant medical records. * Some participants will complete interviews about their experiences and views of TMS during pregnancy.
Official title: Developing Transcranial Magnetic Stimulation as a Therapeutic Modality for Methamphetamine Use Disorder During Pregnancy
Key Details
Gender
FEMALE
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-09
Completion Date
2030-12
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
4- Week Dual-Target Transcranial Magnetic Stimulation (TMS)
Participants will receive dual-target TMS delivered sequentially to the DLPFC and mPFC. Target localization will follow the international 10-20 EEG system using the Beam F3 and FP1 positions, consistent with prior studies. Each session will include iTBS to the DLPFC administered as 2-second trains of 50-Hz triplets delivered at 5 Hz, with an 8-second intertrain interval, totaling 600 pulses, and cTBS to the mPFC consisting of continuous 50-Hz triplets totaling 600 pulses. A total of 16 sessions will be delivered: one/day treatments for 5 days during weeks 1-2, followed by one/day treatments for 3 days during weeks 3-4.
Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS)
Dual-target theta burst TMS delivered using a Elevate TMS cTMS001 system. Each treatment session includes excitatory intermittent theta burst stimulation (iTBS) to the dorsolateral prefrontal cortex and inhibitory continuous theta burst stimulation (cTBS) to the medial prefrontal cortex. Participants receive 16 treatment sessions over 2 weeks using an accelerated treatment schedule.
Treatment as Usual (TAU)
Treatment as usual consists of existing evidence-based treatment approaches available in the community, including contingency management, behavioral counseling, and medications when clinically indicated. Participants do not receive study-administered TMS.