Accelerated rTMS treatment for stimulant use disorder and depression

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

This study is testing if a fast treatment using brain stimulation can help people with stimulant use disorder and depression feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06424184 on ClinicalTrials.gov

What this trial studies

This research involves a feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) aimed at individuals suffering from stimulant use disorder and depression. Participants will be recruited from an ongoing longitudinal study and will undergo screening to determine eligibility. Eligible participants will receive up to four rTMS sessions per day, five days a week, for a total of 50 sessions over three weeks, along with various assessments including EEG and ECG. Follow-up evaluations will occur one week after the final rTMS session to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of moderate to severe stimulant use disorder and a concurrent diagnosis of depression.

Not a fit: Patients with current alcohol or sedative use disorders may not benefit from this study due to safety concerns.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for individuals struggling with both stimulant use disorder and depression.

How similar studies have performed: While this approach is relatively novel, previous studies have shown promise in using rTMS for depression, suggesting potential for success in this combined treatment.

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.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Manish Jha, M.B.B.S — University of Texas Southwestern Medical Center
• Study coordinator: Taylor Helmbrecht, B.S.A.

Conditions Stimulant Use; Depression