Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
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:
- Can pregnant women with methamphetamine use disorder be successfully enrolled and complete TMS treatment?
- Is TMS acceptable to pregnant participants, their caregivers or partners, and clinicians involved in their care?
- 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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Rana Jawish, MD
- Numer telefonu: 8015878626
- E-mail: rana.jawish@hsc.utah.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Standard Dual-Target TMS
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). |
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. |
|
Eksperymentalny: 2-week Dual-Target 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. |
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. |
|
Aktywny komparator: Treatment as Usual
Participants continue receiving standard clinical care for methamphetamine use disorder during pregnancy without study-administered TMS. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility of Recruitment
Ramy czasowe: Pre-enrollment through 6-month follow-up
|
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
Ramy czasowe: Pre-enrollment through 6-month follow-up
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility of collecting maternal outcomes
Ramy czasowe: Baseline through 6-month follow-up
|
Feasibility of collecting maternal outcomes will be defined as collecting greater than or equal to 80% of outcomes. |
Baseline through 6-month follow-up
|
|
Feasibility of collecting neonatal outcomes
Ramy czasowe: Birth through maternal 6-month follow-up
|
Feasibility of collecting neonatal outcomes will be defined as collecting greater than or equal to 80% of outcomes. |
Birth through maternal 6-month follow-up
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maternal Outcomes - Methamphetamine Use timeline Follow-Back
Ramy czasowe: Baseline through 6-month follow-up
|
Exploration of trends in maternal methamphetamine use over time and between groups including change in methamphetamine use (timeline Follow-Back) |
Baseline through 6-month follow-up
|
|
Neonatal outcomes - birth weight
Ramy czasowe: Birth
|
Exploration of trends in neonatal outcomes between groups including weight at birth (lbs). |
Birth
|
|
Safety Measures - adverse events
Ramy czasowe: baseline through 6-month follow-up
|
Incidence, severity, and relatedness of adverse events and serious adverse events from baseline or experienced since the last visit |
baseline through 6-month follow-up
|
|
Maternal Outcomes - Methamphetamine Use (urine drug test)
Ramy czasowe: Screen through 6-month follow-up
|
Exploration of trends in maternal methamphetamine use over time and between groups including change in methamphetamine use (results of urine drug test) |
Screen through 6-month follow-up
|
|
Maternal Outcomes - cravings (Stimulant Craving Questionnaire - SCQ)
Ramy czasowe: Screen through 6-month follow-up
|
Exploration of trends in maternal methamphetamine cravings over time and between groups including change in score on SCQ |
Screen through 6-month follow-up
|
|
Maternal Outcomes - mental health (Patient Health Questionnaire-9 - PHQ-9)
Ramy czasowe: Baseline through 6-month follow-up
|
Exploration of trends in maternal outcomes across time and between groups including change in mental health (change in PHQ-9 score) |
Baseline through 6-month follow-up
|
|
Maternal Outcomes - mental health (Generalized Anxiety Disorder-7 - GAD-7)
Ramy czasowe: Baseline through 6-month follow-up
|
Exploration of trends in maternal outcomes across time and between groups including change in mental health (change in GAD-7 score) |
Baseline through 6-month follow-up
|
|
Maternal Outcomes - sleep health (Pittsburgh Sleep Quality Index - PSQI)
Ramy czasowe: Screen through 6-month follow-up
|
Exploration of trends in maternal outcomes across time and between groups including change in sleep health (change in PSQI score) |
Screen through 6-month follow-up
|
|
Maternal Outcomes - quality of life and satisfaction (Quality of Life Enjoyment and Satisfaction Questionnaire - Q-LES-Q-SF)
Ramy czasowe: Baseline through 6-month follow-up
|
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) |
Baseline through 6-month follow-up
|
|
Maternal Outcomes - physical health indicators (blood pressure)
Ramy czasowe: Baseline through 6-month follow-up
|
Exploration of trends in maternal outcomes across time and between groups including change in physical health indicators (change in blood pressure) |
Baseline through 6-month follow-up
|
|
Maternal Outcomes - physical health indicators (weight gain)
Ramy czasowe: Baseline through 6-month follow-up
|
Exploration of trends in maternal outcomes across time and between groups including change in physical health indicators (change in weight in lbs) |
Baseline through 6-month follow-up
|
|
Maternal Outcomes - physical health indicators (gestational diabetes)
Ramy czasowe: Screen through 6-month follow-up
|
Exploration of trends in maternal outcomes across time and between groups including diagnosis of gestational diabetes |
Screen through 6-month follow-up
|
|
Neonatal outcomes - gestational age at birth
Ramy czasowe: Birth
|
Exploration of trends in neonatal outcomes between groups including gestational age at birth (weeks) |
Birth
|
|
Neonatal outcomes - Apgar scores
Ramy czasowe: Birth
|
Exploration of trends in neonatal outcomes between groups including Apgar scores at birth |
Birth
|
|
Neonatal outcomes - NICU admission and length of stay
Ramy czasowe: Birth
|
Exploration of trends in neonatal outcomes between groups including incidence of NICU admission and length of stay at birth |
Birth
|
|
Neonatal outcomes - neurodevelopment (Ages and Stages Questionnaire, Third Edition (ASQ-3))
Ramy czasowe: Birth through 6-month follow-up
|
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. |
Birth through 6-month follow-up
|
|
Safety measures - Columbia Suicide Severity Rating Scale (C-SSRS)
Ramy czasowe: Screen through post birth 6-month follow-up
|
Suicidal ideation and behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) |
Screen through post birth 6-month follow-up
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Rana Jawish, MD, Utah, University of
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB_00202011
- K23DA065955-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
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.
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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