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

About This Grant

Methamphetamine use disorder (MaUD) during pregnancy is a growing public health crisis, affecting up to 5% of pregnancies in endemic regions. Despite posing serious maternal and neonatal risks, few effective evidence-based treatments exist including contingency management, behavioral counseling, and medications show modest efficacy, and no FDA-approved medications are available for MaUD. Transcranial magnetic stimulation (TMS) is a non-invasive, FDA-approved treatment for depression and nicotine use disorder. TMS has shown promise in reducing cravings and improving abstinence in non-pregnant population with MaUD, and in the context of prenatal depression, TMS has demonstrated favorable outcomes and reassuring safety for both mother and infant. However, its feasibility and acceptability for MaUD during pregnancy has not been tested. My long-term goal is to be an independent clinician-investigator and leader studying the effectiveness of, and employing, novel neuromodulation interventions (including TMS) for treating pregnant women with SUDs. This K23 proposal's objectives are to 1) test the feasibility and acceptability of TMS for MaUD during pregnancy, 2) obtain training in rigorous qualitative and quantitative research methodologies, and 3) attain the professional development skills necessary to establish myself as an independent clinician-investigator. During this award, I will conduct a mixed-methods feasibility trial of TMS in MaUD during pregnancy. My central hypothesis is that TMS is a feasible and acceptable intervention for the treatment of MaUD during pregnancy. To accomplish my long-term goal and immediate objectives, I will develop skills in conducting high quality prospective clinical trials on innovative interventions in this population. I will gain skills in conducting patient-centered qualitative research to enhance clinical trial participation and advance treatment interventions in this high-risk population. Specific Aim 1 will evaluate the feasibility of treating MaUD during pregnancy with TMS in a pilot randomized controlled trial with 45 pregnant women with MaUD. Participants will be randomized equally into three arms: dual target 4-week daily TMS, dual target 2-week accelerated TMS, and treatment as usual. Specific Aim 2 will qualitatively assess TMS acceptability for treating MaUD during pregnancy. Semi-structured interviews will be conducted with 15 clinical trial participants, 15 identified partners/caregivers, and 15 clinicians, to explore participants’ experiences with the trial and identify barriers and facilitators to participation and retention. Real-time feedback will inform modifications to study procedures, enhancing engagement and trial completion, and will also inform the design of future trials. Specific Aim 3 will assess the feasibility of collecting maternal and neonatal outcomes during the trial and at 1 and 6 months follow up after trial. This work will address a critical gap by generating knowledge about the feasibility and acceptability a potentially novel, non-pharmacological, safe, and effective intervention tailored for this population, ultimately improving maternal and neonatal outcomes and transforming care for pregnant women with MaUD.