NCT06790576 Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder
| NCT ID | NCT06790576 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Minnesota |
| Condition | Stimulant Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits. Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network. Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants. Step 3: Following randomization, the study will administer a pre-iTBS assessment. Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group. Step 5: The study will administer a post-iTBS assessment.
Eligibility Criteria
Inclusion Criteria: * Age 18 or older * Ability to provide consent and comply with all study procedures. * Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants). * At least 2 weeks of abstinence from substance use (other than caffeine or nicotine). * Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants). * Confident level of English language proficiency. Exclusion Criteria: * Any organic brain disorder (e.g. TBI, stroke). * Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes. * TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device). * MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia). * Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included). * Presence of a condition that would render study measures impossible to administer or interpret. * Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine. * Greater than 9 months abstinence from substance use (does not apply to healthy control participants). * Pregnancy or breastfeeding.
Contact & Investigator
Alexander Optiz
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06790576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stimulant Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06790576 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06790576 currently recruiting?
Yes, NCT06790576 is actively recruiting participants. Contact the research team at stima011@umn.edu for enrollment information.
Where is the NCT06790576 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06790576 clinical trial?
NCT06790576 is sponsored by University of Minnesota. The principal investigator is Alexander Optiz at University of Minnesota. The trial plans to enroll 50 participants.