Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy

NCT07849530 | Not Yet Recruiting FDA Device

• 2 other identifiers: IRB_00202011K23DA065955-01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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.

Conditions

Methamphetamine Use Disorder; Pregnancy

Keywords

Transcranial Magnetic Stimulation (TMS); Stimulant Use Disorder; Pregnant Women; Substance Use Disorder; Neuromodulation; Maternal Health; Neonatal Outcomes

Outcome Measures

Primary Outcomes (2)

• Feasibility of Recruitment

  Feasibility of recruitment will be assessed by measuring enrollment rates (participants enrolled divided by eligible participants)

  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.

  Pre-enrollment through 6-month follow-up

Secondary Outcomes (2)

• Feasibility of collecting maternal outcomes

  Baseline through 6-month follow-up

• Feasibility of collecting neonatal outcomes

  Birth through maternal 6-month follow-up

Other Outcomes (17)

• Maternal Outcomes - Methamphetamine Use timeline Follow-Back

  Baseline through 6-month follow-up

• Neonatal outcomes - birth weight

  Birth

• Safety Measures - adverse events

  baseline through 6-month follow-up

Study Arms (3)

Standard Dual-Target TMS

EXPERIMENTAL

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)

2-week Dual-Target TMS

EXPERIMENTAL

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)

Treatment as Usual

ACTIVE COMPARATOR

Participants continue receiving standard clinical care for methamphetamine use disorder during pregnancy without study-administered TMS.

Other: Treatment as Usual (TAU)

Interventions

4- Week Dual-Target Transcranial Magnetic Stimulation (TMS) DEVICE

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.

Standard Dual-Target TMS

Treatment as Usual (TAU) OTHER

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.

Treatment as Usual

Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS) DEVICE

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.

2-week Dual-Target TMS

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 22 years and older who are pregnant with a singleton pregnancy
• \>12 weeks and ≤ 34 weeks gestational age at screening
• Diagnosis of MaUD in the past 12 months
• Participant must have engaged in perinatal care (through family medicine, Obstetrics/Gynecology, Internal Medicine, etc) during this pregnancy
• Capacity to consent
• Capacity to complete all study procedures

You may not qualify if:

• Lifetime diagnosis of schizophrenia, bipolar disorder, schizoaffective disorder, or psychosis
• Actively suicidal or homicidal
• Active heavy alcohol use
• Using any medication that significantly increases the risk of seizure by lowering seizure threshold (for example Wellbutrin over 300 mg daily) or antipsychotics
• History of epilepsy, a personal history of seizures, or a family history of epilepsy or seizure in a first degree relative
• History of intracranial hemorrhage, stroke in the past 12 months, intracranial mass, or head trauma in the past 12 months
• History of or current diagnosis of chronic hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), and/or history of or current diagnosis of preeclampsia
• Moderate to severe heart disease
• Any medical condition that in the PI's opinion will interfere with the study or increase risk to the participant
• Current participation in another clinical trial (excluding large population-based or observational studies like All of Us)
• Not able to complete the protocol due to travel, work, etc

Sponsors & Collaborators

• University of Utah: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rana Jawish, MD

  Utah, University of

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Jawish, MD

CONTACT

8015878626; rana.jawish@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is designed to assess whether TMS is a feasible and acceptable treatment for methamphetamine use disorder during pregnancy.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available no later than publication of the primary study outcomes or at the conclusion of the funding period, whichever occurs first, and will remain available indefinitely.
• Access Criteria: De-identified participant-level data will be available through The Hive repository at the University of Utah. Data sharing will comply with University of Utah and NIH policies. Data identified as sensitive or potentially re-identifiable may require controlled access, including data use agreements and IRB approvals when applicable.