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Methamphetamine Use DisorderNCT07849530

Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy

A study testing 4- Week Dual-Target Transcranial Magnetic Stimulation (TMS), Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS) and Treatment as Usual (TAU) in people with Methamphetamine Use Disorder and Pregnancy, run by University of Utah.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older, women only
Conditions the study is for
Methamphetamine Use Disorder, Pregnancy
What is being tested?
4- Week Dual-Target Transcranial Magnetic Stimulation (TMS), Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS) and Treatment as Usual (TAU)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Unable to receive the TMS treatment (e.g. have metal implants, metal device(s) in their head or body, cochlear implants, implanted brain stimulators, aneurysm clips). Dental implants that are TMS safe are not exclusionary)
  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Rana Jawish, MD contact

8015878626

rana.jawish@hsc.utah.edu

About this study

Official title: Developing Transcranial Magnetic Stimulation as a Therapeutic Modality for Methamphetamine Use Disorder During Pregnancy

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:

Read more
  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.
Read the detailed description

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.

Being tested
4- Week Dual-Target Transcranial Magnetic Stimulation (TMS), Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS), Treatment as Usual (TAU)
Keywords
Transcranial Magnetic Stimulation (TMS), Stimulant Use Disorder, Pregnant Women, Substance Use Disorder, Neuromodulation, Maternal Health, Neonatal Outcomes
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

Study groups in NCT07849530
Study groupRoleWhat they receive
Standard Dual-Target TMSExperimentalParticipants 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).
Receives: Device: 4- Week Dual-Target Transcranial Magnetic Stimulation (TMS)
2-week Dual-Target TMSExperimentalParticipants 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.
Receives: Device: Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS)
Treatment as UsualActive comparatorParticipants continue receiving standard clinical care for methamphetamine use disorder during pregnancy without study-administered TMS.
Receives: Other: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment

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

    Measured: Pre-enrollment through 6-month follow-up

  2. 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.

    Measured: Pre-enrollment through 6-month follow-up

Secondary outcomes (2)
  1. Feasibility of collecting maternal outcomes

    Feasibility of collecting maternal outcomes will be defined as collecting greater than or equal to 80% of outcomes.

    Measured: Baseline through 6-month follow-up

  2. Feasibility of collecting neonatal outcomes

    Feasibility of collecting neonatal outcomes will be defined as collecting greater than or equal to 80% of outcomes.

    Measured: Birth through maternal 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is designed to assess whether TMS is a feasible and acceptable treatment for methamphetamine use disorder during pregnancy.
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07849530
Sponsor's protocol ID
IRB_00202011
Other IDs
K23DA065955-01
Status last verified
Sep 2026
First submitted
25 Aug 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing 4- Week Dual-Target Transcranial Magnetic Stimulation (TMS), Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS) and Treatment as Usual (TAU) in people with Methamphetamine Use Disorder and Pregnancy, run by University of Utah.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rana Jawish, MD (8015878626, rana.jawish@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment (time frame: Pre-enrollment through 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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