What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment being studied for Stimulant Use Disorder (SUD). Known side effects of rTMS include mild and transient discomfort at the stimulation site, headaches, scalp discomfort, and, rarely, seizures. These side effects are generally well-tolerated and do not result in serious adverse events. Other treatments for SUD, such as medications like topiramate and varenicline, can have side effects including impaired concentration, confusion, dizziness, anxiety, and paresthesias for topiramate, and nausea, insomnia, and abnormal dreams for varenicline.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Stimulant Use Disorder (SUD). Repetitive Transcranial Magnetic Stimulation (rTMS) is being studied as a promising treatment option for SUD, but it has not yet received FDA approval for this indication. rTMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity and has shown potential in treating various psychiatric and neurological conditions.

What other types of research exist?

Promising novel alternatives to rTMS for Stimulant Use Disorder patients include transcranial direct current stimulation (tDCS), which has been studied for inattention in ADHD and may have potential for SUD, and noninvasive vagus nerve stimulation (nVNS), which has shown efficacy in other neurological conditions and could be explored for SUD treatment.

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Device

rTMS for Stimulant Addiction (VA-StARTS Trial)

N/A

Waitlist Available

Led By Jong H. Yoon, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

SCID confirmed diagnosis of SUD, severe

IQ > 80

Must not have

On medications thought to significantly lower seizure threshold: clozapine, chlorpromazine, clomipramine, bupropion > 400 mg/day, Use of direct dopaminergic antagonists or agonists

History of seizures or conditions known to substantially increase risk for seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 week before and after rtms treatment

Summary

This trial is testing rTMS, a treatment that uses magnetic fields to stimulate brain cells, on Veterans with stimulant use disorder. The goal is to see if rTMS can help reduce cravings and improve control over substance use. Repetitive transcranial magnetic stimulation (rTMS) has been used to reduce craving in different substance use disorders, including alcohol, nicotine, and illicit drugs.

Who is the study for?

This trial is for Veterans with severe stimulant use disorder (SUD) who have not used stimulants for 1-6 weeks. Participants must be able to undergo cognitive tests, fMRI scans, and rTMS treatment without contraindications, have an IQ over 80, a stable medication regimen and living situation. Exclusions include incompatible implants or devices, unstable medical/psychiatric conditions, other active substance disorders (except PTSD), pregnancy/lactation, prior adverse reaction to TMS or medications lowering seizure threshold.

What is being tested?

The study is testing repetitive transcranial magnetic stimulation (rTMS) as a potential new treatment for SUD in Veterans. It aims to establish the feasibility of rTMS application in this population and evaluate its effectiveness while identifying biomarkers that could predict which patients will benefit most from this therapy.

What are the potential side effects?

Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The risk of seizures is higher if participants are on certain medications or have specific medical conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe substance use disorder diagnosis.

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My IQ is above 80.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on high-risk seizure medications like clozapine or bupropion over 400 mg/day.

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I have a history of seizures or conditions that raise my seizure risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 week before rtms treatment, midpoint during rtms treatment, within 1 week after rtms treatment, and 3 months following rtms treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 week before rtms treatment, midpoint during rtms treatment, within 1 week after rtms treatment, and 3 months following rtms treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 week before rtms treatment, midpoint during rtms treatment, within 1 week after rtms treatment, and 3 months following rtms treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse rate

Secondary study objectives

Occupational/role functioning

Rest/activity cycles

Reward circuit function and signaling

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active rTMSExperimental Treatment1 Intervention

Receive active rTMS

Group II: Sham rTMSPlacebo Group1 Intervention

Receive sham rTMS

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive transcranial magnetic stimulation (rTMS)

2021

Completed Phase 4

~730

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment for Stimulant Use Disorder (SUD) that uses magnetic fields to modulate neural activity in specific brain regions, particularly the prefrontal cortex. This area is involved in addiction and reward pathways, and rTMS aims to reduce cravings and improve self-control by altering neural circuits. This mechanism is significant for SUD patients as it provides a treatment option that directly influences brain function without relying on medications, which can have side effects or potential for misuse.