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Accelerated rTMS for Substance Use Disorder and Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (1)

TX