Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy

ConditionsMethamphetamine Use Disorder Pregnancy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age22+

SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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 groups

45 Participants

are divided into 3 treatment groups

Group A: Standard Dual-Target TMSExperimental treatment 1 intervention

Group B: 2-week Dual-Target TMSExperimental treatment 1 intervention

Group C: Treatment as UsualActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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