An interventional study of 4- Week Dual-Target Transcranial Magnetic Stimulation (TMS) and Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS) in Methamphetamine Use Disorder and Pregnancy, sponsored by University of Utah. Not yet recruiting. Open to female participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Utah · Not applicable, Interventional, and Other
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:
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:
This is a three-arm, randomized, controlled feasibility trial evaluating transcranial magnetic stimulation (TMS) as a potential treatment for methamphetamine use disorder (MaUD) during pregnancy. The study aims to 1) assess the feasibility of recruitment, retention, and intervention delivery among pregnant women with MaUD, 2) assess the feasibility of collecting maternal health outcomes, and 3) assess the feasibility of collecting postnatal neonatal outcomes.
Up to 45 pregnant participants will be enrolled and randomized in equal proportions (1:1:1) to: (1) standard TMS (16 sessions over 4 weeks), (2) accelerated TMS (aTMS; 16 sessions over 2 weeks), or (3) treatment as usual (TAU). The TAU group will continue with existing care, including contingency management, behavioral counseling, and other standard treatments available in the community. Randomization will be stratified based on the presence of co-occurring substance use disorders and implemented using a secure REDCap randomization module with permuted block allocation. Participants will be followed through pregnancy and until 6 months postpartum.
Eligible participants are pregnant women aged 22 years and older with a diagnosis of active methamphetamine use disorder and a gestational age of 34 weeks or less at enrollment. Participants with contraindications to TMS or medical or psychiatric conditions that substantially increase risk, including seizure disorders, bipolar I disorder, schizophrenia spectrum disorders, or active alcohol use disorder, will be excluded.
All TMS procedures will be conducted at the Huntsman Mental Health Institute using a TMS system with theta burst stimulation capabilities. Treatment will utilize a dual-target stimulation approach consisting of excitatory intermittent theta burst stimulation (iTBS) directed at the dorsolateral prefrontal cortex (DLPFC) and inhibitory continuous theta burst stimulation (cTBS) directed at the medial prefrontal cortex (mPFC). Stimulation intensity will be individualized using each participant's resting motor threshold and gradually increased during initial treatment sessions as tolerated.
Participants randomized to the standard TMS arm will receive 16 treatment sessions delivered over 4 weeks. Participants randomized to the accelerated TMS arm will receive the same total number of treatment sessions delivered over 2 weeks using an accelerated treatment schedule. Participants assigned to treatment as usual will continue receiving available evidence-based clinical care without TMS.
The primary feasibility outcomes include recruitment rates, screening completion, enrollment rates, randomization success, retention throughout treatment and follow-up, completion of TMS sessions, participant adherence, and completion of study assessments. Acceptability outcomes include participant satisfaction, treatment burden, and willingness to participate in future TMS studies.
Maternal outcomes will be collected throughout pregnancy and during follow-up and will include measures of methamphetamine use frequency, substance use severity, craving, depression, anxiety, sleep quality, quality of life, cognitive functioning, urine drug testing results, and physical health indicators. Data will be collected using validated self-report instruments, clinical assessments, medical record review, and biologic measures where applicable.
Neonatal outcomes will be assessed through medical record review and follow-up assessments and will include gestational age at delivery, birth weight, Apgar scores, neonatal intensive care unit admission, neonatal length of stay, and developmental outcomes through 6 months postpartum. Infant development will be evaluated using the Ages and Stages Questionnaire, Third Edition (ASQ-3), and supplemented by pediatric health record review when available.
This study is not powered to evaluate treatment efficacy. Rather, the purpose of the study is to establish the feasibility and acceptability of TMS for methamphetamine use disorder during pregnancy and to determine the feasibility of collecting maternal and neonatal outcome data needed for a future fully powered randomized clinical trial.
Exclusion Criteria:
Participants receive 16 sessions of dual-target transcranial magnetic stimulation (TMS) delivered over 4 weeks. Treatment includes intermittent theta burst stimulation (iTBS) to the dorsolateral prefrontal cortex (DLPFC) followed by continuous theta burst stimulation (cTBS) to the medial prefrontal cortex (mPFC).
Device: 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: 3-4 sessions/day (with 30-60 minutes between sessions) delivered on 4-5 treatment days within a 2-week timeframe.
Device: Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS)
Participants continue receiving standard clinical care for methamphetamine use disorder during pregnancy without study-administered TMS.
Other: Treatment as Usual (TAU)
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.
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 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.
Feasibility of Recruitment
Feasibility of recruitment will be assessed by measuring enrollment rates (participants enrolled divided by eligible participants)
Time frame: Pre-enrollment through 6-month follow-up
Feasibility of Retention
Feasibility of retention will be assessed by measuring retention rates (completion of greater than or equal to 80% of 16 TMS sessions) in the TMS groups.
Time frame: Pre-enrollment through 6-month follow-up
Feasibility of collecting maternal outcomes
Feasibility of collecting maternal outcomes will be defined as collecting greater than or equal to 80% of outcomes.
Time frame: Baseline through 6-month follow-up
Feasibility of collecting neonatal outcomes
Feasibility of collecting neonatal outcomes will be defined as collecting greater than or equal to 80% of outcomes.
Time frame: Birth through maternal 6-month follow-up
Maternal Outcomes - Methamphetamine Use timeline Follow-Back
Exploration of trends in maternal methamphetamine use over time and between groups including change in methamphetamine use (timeline Follow-Back)
Time frame: Baseline through 6-month follow-up
Neonatal outcomes - birth weight
Exploration of trends in neonatal outcomes between groups including weight at birth (lbs).
Time frame: Birth
Safety Measures - adverse events
Incidence, severity, and relatedness of adverse events and serious adverse events from baseline or experienced since the last visit
Time frame: baseline through 6-month follow-up
Maternal Outcomes - Methamphetamine Use (urine drug test)
Exploration of trends in maternal methamphetamine use over time and between groups including change in methamphetamine use (results of urine drug test)
Time frame: Screen through 6-month follow-up
Maternal Outcomes - cravings (Stimulant Craving Questionnaire - SCQ)
Exploration of trends in maternal methamphetamine cravings over time and between groups including change in score on SCQ
Time frame: Screen through 6-month follow-up
Maternal Outcomes - mental health (Patient Health Questionnaire-9 - PHQ-9)
Exploration of trends in maternal outcomes across time and between groups including change in mental health (change in PHQ-9 score)
Time frame: Baseline through 6-month follow-up
Maternal Outcomes - mental health (Generalized Anxiety Disorder-7 - GAD-7)
Exploration of trends in maternal outcomes across time and between groups including change in mental health (change in GAD-7 score)
Time frame: Baseline through 6-month follow-up
Maternal Outcomes - sleep health (Pittsburgh Sleep Quality Index - PSQI)
Exploration of trends in maternal outcomes across time and between groups including change in sleep health (change in PSQI score)
Time frame: Screen through 6-month follow-up
Maternal Outcomes - quality of life and satisfaction (Quality of Life Enjoyment and Satisfaction Questionnaire - Q-LES-Q-SF)
Exploration of trends in maternal outcomes across time and between groups including change in quality of life and satisfaction (change in Q-LES-Q-SF score)
Time frame: Baseline through 6-month follow-up
Maternal Outcomes - physical health indicators (blood pressure)
Exploration of trends in maternal outcomes across time and between groups including change in physical health indicators (change in blood pressure)
Time frame: Baseline through 6-month follow-up
Maternal Outcomes - physical health indicators (weight gain)
Exploration of trends in maternal outcomes across time and between groups including change in physical health indicators (change in weight in lbs)
Time frame: Baseline through 6-month follow-up
Maternal Outcomes - physical health indicators (gestational diabetes)
Exploration of trends in maternal outcomes across time and between groups including diagnosis of gestational diabetes
Time frame: Screen through 6-month follow-up
Neonatal outcomes - gestational age at birth
Exploration of trends in neonatal outcomes between groups including gestational age at birth (weeks)
Time frame: Birth
Neonatal outcomes - Apgar scores
Exploration of trends in neonatal outcomes between groups including Apgar scores at birth
Time frame: Birth
Neonatal outcomes - NICU admission and length of stay
Exploration of trends in neonatal outcomes between groups including incidence of NICU admission and length of stay at birth
Time frame: Birth
Neonatal outcomes - neurodevelopment (Ages and Stages Questionnaire, Third Edition (ASQ-3))
Exploration of trends in neonatal outcomes across time and between groups including neurodevelopment as assessed using the Ages and Stages Questionnaire, Third Edition (ASQ-3) at 2, 4 and 6 months after birth.
Time frame: Birth through 6-month follow-up
Safety measures - Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation and behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Screen through post birth 6-month follow-up
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying published results will be shared, including demographic information, maternal and neonatal health outcomes, substance use measures, mental health assessments, TMS treatment adherence data, and qualitative interview data that have been de-identified in accordance with IRB approval and participant consent. Supporting documentation including data dictionaries, codebooks, study protocols, and analytic code will also be made available.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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