Accelerated rTMS for Substance Use Disorder and Depression
Recruiting · NCT06424184 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Accelerated Repetitive Transcranial Magnetic Stimulation
What this trial is 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 \[including methamphetamine or cocaine use disorder (MUD/CUD)\].
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States