Optimizing brain stimulation techniques for stimulant use disorder

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

This study is testing different brain stimulation techniques to see if they can help adults with stimulant use disorder who have recently stopped using drugs.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Minnesota (other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT06790576 on ClinicalTrials.gov

What this trial studies

This study aims to recruit 50 adults diagnosed with stimulant use disorder who have been abstinent for at least two weeks, along with 10 healthy controls for initial configuration. Participants will undergo a 3T MRI scan to accurately map the prefrontal cortex and analyze resting fMRI connectivity to identify optimal TMS locations. Following this, participants will be randomized into three groups to receive different types of TMS treatment, either synchronized or unsynchronized with EEG readings. The study will be conducted over two lab visits, focusing on the efficacy of TMS in treating stimulant use disorder.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with a primary diagnosis of stimulant use disorder and at least two weeks of abstinence from substance use.

Not a fit: Patients with organic brain disorders, significant head injuries, or contraindications to TMS or MRI will not benefit from this study.

Why it matters

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

How similar studies have performed: While the use of TMS for various disorders has shown promise, this specific approach combining TMS with EEG synchronization is relatively novel and has not been extensively tested.

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.

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Kelvin Lim — University of Minnesota
• Study coordinator: Melnie Martie

Conditions: Stimulant Use Disorder, TMS, MRI