Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Stimulant Use Disorder

• Registration Number: NCT07112105
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-25
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2026-01-01
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
• Last use of stimulants >2 and <8 weeks
• Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
• Stable medical health

Exclusion Criteria

• Pregnant or lactating female
• History of prior adverse reaction to TMS
• On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion > 400mg/day
• Seizure disorder or conditions known to substantially increase risk for seizures
• Implants or medical devices incompatible with TMS
• Acute or unstable chronic medical illness that would affect participation or compliance in the study, e.g. unstable angina
• Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis
• Other substance use disorder not in remission
• Chronic or recurring Axis I psychotic disorders
• For subjects participating in fMRI scans, presence of ferromagnetic material in their body or taking DAergic medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Relapsed	3 months after last rTMS treatment	Rate of stimulant use relapse compared between active vs. sham rTMS groups

Secondary Outcome Measures

Name	Time	Method
Reward circuit function and signaling	Within 1 week before rTMS treatment and within 1 week after rTMS treatment	Before and after treatment, participants will undergo functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra will be measured in an individual-subject, "native space" region of interest approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling will be compared between active vs. sham rTMS groups.

Trial Locations

Locations (1)

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States