Accelerated rTMS for Substance Use Disorder and Depression

The University of Texas System (UT)

Status: Enrolling

Conditions: Stimulant Use; Depression

Treatments: Device: Accelerated Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06424184

STU-2024-0232

Details and patient eligibility

About

This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with depression and stimulant use disorder [including methamphetamine or cocaine use disorder (MUD/CUD)].

Full description

This research is an open label feasibility trial of accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with stimulant use disorder. Participants will be recruited from an existing and ongoing longitudinal study of stimulant use disorder (STIM-RAD) (NCT06073340). Prior to initiating the accelerated course of rTMS, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete up to four (4) rTMS sessions of intermittent theta burst over left dorsolateral prefrontal cortex per day, up to five (5) days per week of the study, for a total of 50 sessions over a three (3) week period and will undergo electroencephalography (EEG), electrocardiography (ECG), urine drug screens, as well as self-report and clinician-rated assessments. A follow-up visit will be conducted 1 week after the last session of rTMS.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be aged 18-65 years, inclusive.
2. Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions, and be willing to comply with all study procedure instructions.
3. Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
4. Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) or other Stimulant Use Disorder over the past 12 months (as determined by the MINI International Neuropsychiatric Interview).
5. Have a PHQ9 of greater than or equal to five (5).
6. Be willing to provide urine samples, EEGs, and ECGs.
7. Be willing to use appropriate birth control method during the treatment phase of the study, if individual is of childbearing potential.

Exclusion criteria

1. Have a current pattern of alcohol, benzodiazepine, or other sedative/hypnotic use that would preclude safe participation in the study, as determined by the PI or their designee.
2. Have a history of a serious medical disorder that, in the opinion of the PI or their designee, would make it unsafe to participate in the study or may prevent collection of study data (e.g., disabling terminal diagnosis for which hospice care is being sought; serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy and/or is clinically stable on therapy, in the opinion of the PI or their designee, prior to study entry).
3. Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
4. Have a documented history of brain lesion(s) and/or tumor(s).
5. Have metal implants or non-removable metal objects above the neck.
6. Current pregnancy as determined by a urine screening.
7. Current or lifetime manic or hypomanic episode, defined by MINI diagnostic interview.
8. Current psychotic disorder.
9. Are a prisoner or in police custody at the time of eligibility screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

rTMS Intervention

Experimental group

Description:

Eligible participants who are enrolled will receive an accelerated course of repetitive Transcranial Magnetic Stimulation.

Treatment:

Device: Accelerated Repetitive Transcranial Magnetic Stimulation