RecruitingNot ApplicableNCT06424184

Accelerated rTMS for Substance Use Disorder and Depression

Substance Use Disorder Treatment With Accelerated Repetitive Transcranial Magnetic Stimulation for Depression (START-D)

Sponsor

University of Texas Southwestern Medical Center

Enrollment

40 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Stimulant Use

Summary

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 \[including methamphetamine or cocaine use disorder (MUD/CUD)\].

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Be aged 18-65 years, inclusive.
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.
Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
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).
Have a PHQ9 of greater than or equal to five (5).
Be willing to provide urine samples, EEGs, and ECGs.
Be willing to use appropriate birth control method during the treatment phase of the study, if individual is of childbearing potential.

Exclusion Criteria9

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.
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).
Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
Have a documented history of brain lesion(s) and/or tumor(s).
Have metal implants or non-removable metal objects above the neck.
Current pregnancy as determined by a urine screening.
Current or lifetime manic or hypomanic episode, defined by MINI diagnostic interview.
Current psychotic disorder.
Are a prisoner or in police custody at the time of eligibility screening.

Interventions

DEVICEAccelerated Repetitive Transcranial Magnetic Stimulation

The rTMS protocol implemented in this study will include approximately 10-minute long sessions of intermittent theta burst stimulation (iTBS) with at least 50 minutes in between iTBS sessions. Study participants will receive the rTMS intervention for up to 50 sessions across a three-week period. The total of 50 sessions will be administered as up to 4 sessions each day, up to 5 days per week over an up to 3-week-long period.