Accelerated rTMS for Substance Use Disorder and Depression

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option called repetitive transcranial magnetic stimulation (rTMS) for individuals who are dealing with depression and stimulant use disorders, such as those related to cocaine or methamphetamine. The study aims to see if an accelerated course of rTMS can help improve symptoms in these patients. They are currently looking for participants aged 18 to 65 who have used stimulants at least 10 times in the past month and have moderate to severe stimulant use disorder along with depression.

If you or someone you know is interested in participating, you’ll need to be able to understand and communicate in English and provide consent for the study. Participants will undergo some medical tests, including urine samples and brain activity monitoring, and must agree to use birth control if they are able to become pregnant during the treatment. However, individuals with certain medical conditions, a history of seizures, or those who are currently pregnant cannot take part in the study. This trial is a great opportunity for eligible individuals seeking support for their substance use and depression.

Gender

ALL

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.

Trial Officials