30 Participants Needed

rTMS for Stimulant Addiction

(VA-StARTS Trial)

JH
Overseen ByJong H Yoon, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that your medication regimen remains stable, meaning you should not change the dose or type of medications you are taking from two weeks before the study starts and throughout the treatment phase. However, if you are on certain medications that lower the seizure threshold or are direct dopaminergic agents, you may need to stop those.

What data supports the effectiveness of the treatment rTMS for stimulant addiction?

Research suggests that repetitive transcranial magnetic stimulation (rTMS) can reduce cravings for substances like tobacco, alcohol, and cocaine by stimulating specific brain areas. Studies indicate that high-frequency rTMS applied to the dorsolateral prefrontal cortex may help decrease substance use and cravings, making it a promising treatment for addiction.12345

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, with safety guidelines established and updated over the years. It is a non-invasive brain stimulation method used in various conditions, including addiction, and has been shown to be relatively safe in clinical settings.45678

How is rTMS treatment different from other treatments for stimulant addiction?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive brain stimulation technique that can change brain activity and connections, potentially reducing cravings and addictive behaviors without the need for medication. Unlike traditional treatments, rTMS targets specific brain areas to modulate neurotransmitter systems, which may help in treating stimulant addiction.125910

Research Team

JH

Jong H. Yoon, MD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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.

Inclusion Criteria

Stable social environment and housing to enable regular attendance at clinic visits
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)
Ability to undergo cognitive testing, fMRI scans, and rTMS (no contraindications)
See 6 more

Exclusion Criteria

Pregnant or lactating female
You have implants or medical devices that cannot be used with TMS (Transcranial Magnetic Stimulation).
You have had a bad reaction to TMS treatment in the past.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham repetitive transcranial magnetic stimulation (rTMS) for stimulant use disorder

2 weeks
Daily visits for rTMS sessions

Follow-up

Participants are monitored for relapse rate, occupational functioning, and rest/activity cycles after rTMS treatment

3 months
Visits at 1 week, midpoint, and 3 months post-treatment

Treatment Details

Interventions

  • Repetitive transcranial magnetic stimulation (rTMS)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
Receive active rTMS
Group II: Sham rTMSPlacebo Group1 Intervention
Receive sham rTMS

Repetitive transcranial magnetic stimulation (rTMS) is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as rTMS for:
  • Major depressive disorder
  • Obsessive-compulsive disorder
  • Migraine prevention
🇪🇺
Approved in European Union as rTMS for:
  • Major depressive disorder
  • Obsessive-compulsive disorder
🇨🇦
Approved in Canada as rTMS for:
  • Major depressive disorder
  • Obsessive-compulsive disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Findings from Research

Transcranial magnetic stimulation (TMS) has been explored in 19 studies involving 316 adults for its potential to reduce drug cravings and use, particularly targeting the dorsolateral prefrontal cortex with high-frequency pulses.
While some studies showed promising results, such as decreased smoking and cocaine use, the treatment is still experimental, and the exact mechanisms and optimal parameters for rTMS in addiction treatment remain unclear.
Transcranial magnetic stimulation in the treatment of substance addiction.Gorelick, DA., Zangen, A., George, MS.[2022]
Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment for cocaine and methamphetamine use disorders by potentially inducing beneficial changes in brain circuits related to addiction, particularly affecting dopamine and glutamate systems.
Clinical studies indicate that rTMS can alter brain network connectivity, which may help reduce cravings in individuals with substance use disorders, suggesting a new avenue for effective treatment where no FDA-approved options currently exist.
rTMS-Induced Changes in Glutamatergic and Dopaminergic Systems: Relevance to Cocaine and Methamphetamine Use Disorders.Moretti, J., Poh, EZ., Rodger, J.[2020]
In a study involving 10 treatment-seeking cocaine addicts, bilateral repetitive transcranial magnetic stimulation (rTMS) of the prefrontal cortex did not show a statistically significant difference in cocaine intake compared to sham treatment over time.
However, exploratory analysis revealed a trend towards reduced cocaine consumption in the active rTMS group, with significant reductions observed at 3 months and at the end of treatment, suggesting potential long-term benefits that warrant further investigation.
Bilateral Transcranial Magnetic Stimulation of the Prefrontal Cortex Reduces Cocaine Intake: A Pilot Study.Bolloni, C., Panella, R., Pedetti, M., et al.[2022]

References

Transcranial magnetic stimulation in the treatment of substance addiction. [2022]
rTMS-Induced Changes in Glutamatergic and Dopaminergic Systems: Relevance to Cocaine and Methamphetamine Use Disorders. [2020]
Bilateral Transcranial Magnetic Stimulation of the Prefrontal Cortex Reduces Cocaine Intake: A Pilot Study. [2022]
Repetitive transcranial magnetic stimulation and drug addiction. [2019]
High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. [2022]
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]
7.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Role of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment of Addiction and Related Disorders: A Systematic Review. [2018]
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]
Low-frequency repetitive transcranial magnetic stimulation inhibits the development of methamphetamine-induced conditioned place preference. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
The use of repetitive transcranial magnetic stimulation for modulating craving and addictive behaviours: a critical literature review of efficacy, technical and methodological considerations. [2015]