Repetitive Transcranial Magnetic Stimulation for Stimulant Use Disorder

(VA-StARTS Trial)

JH
Overseen ByJong H Yoon, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called repetitive transcranial magnetic stimulation (rTMS) for individuals with stimulant use disorder (SUD). Currently, no FDA-approved treatments like this exist for SUD, so researchers aim to determine if rTMS can help. The trial includes two groups: one receiving real rTMS and the other a placebo for comparison. Veterans with a confirmed severe SUD diagnosis, who have not used stimulants for more than 8 weeks and are on stable medication, may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in a field with limited treatment options.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications as long as they have been stable for at least 2 weeks before the study and remain unchanged during the treatment phase. However, if you are on certain medications that lower the seizure threshold, like clozapine or high doses of bupropion, you may not be eligible to participate.

What prior data suggests that this technique is safe for treating stimulant use disorder?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe when used correctly. Research involving many participants has found that rTMS is well-tolerated. However, some people experienced mild side effects like neck pain, and in rare cases, seizures.

These side effects are more likely if the treatment does not follow approved guidelines. Therefore, proper screening of participants before starting rTMS is crucial. When performed correctly, rTMS has been safely used in many studies. Those considering this treatment should discuss potential risks with a healthcare provider.12345

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it offers a non-invasive approach to treating Stimulant Use Disorder, which sets it apart from conventional options like behavioral therapies or medication-assisted treatments. Unlike standard treatments that typically focus on managing withdrawal symptoms or reducing cravings through medication, rTMS uses magnetic fields to stimulate specific areas of the brain involved in addiction. Researchers are excited about rTMS because it has the potential to directly alter brain activity patterns associated with addiction, offering a novel pathway for recovery that doesn't rely on pharmaceuticals.

What evidence suggests that repetitive transcranial magnetic stimulation is effective for stimulant use disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) may help treat stimulant use disorder. This trial will assign participants to receive either active rTMS or sham rTMS. Some studies have found that patients experienced fewer drug cravings and improvements in mood and anxiety. One study found that rTMS led to lasting reductions in cocaine use, while another suggested it might help reduce cravings for amphetamines. Although rTMS is not yet widely approved for treating stimulant use disorder, these early results are promising.16789

Who Is on the Research Team?

JH

Jong H. Yoon, MD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for veterans with stimulant use disorder (SUD) who are seeking treatment. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
My health condition is stable.
Last use of stimulants >2 and <8 weeks
See 1 more

Exclusion Criteria

Other substance use disorder not in remission
Pregnant or lactating female
History of prior adverse reaction to TMS
See 7 more

Timeline for a Trial Participant

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

6 weeks
Multiple visits for rTMS sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including relapse rates and reward circuit function

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)
Trial Overview The trial is testing repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, against a sham (placebo) procedure to see if it can help treat SUD in veterans.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
Group II: Sham rTMSPlacebo Group1 Intervention

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+

Citations

Efficacy of Repetitive Transcranial Magnetic Stimulation in ...The positive SMD results indicated the improvement of clinical symptoms after the treatment with add-on rTMS. rTMS showed a more significant effect than the ...
Repetitive transcranial magnetic stimulation for stimulant use ...Additionally, the study aims to evaluate the efficacy of rTMS in reducing stimulant use and craving, the impact of rTMS on mood, anxiety, sleep, ...
Effects of Repetitive Transcranial Magnetic Stimulations in ...The study aims to better understand how rTMS might help reduce amphetamine cravings and improve outcomes, potentially leading to new treatment ...
The effects of repetitive transcranial magnetic stimulation ...Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder ( ...
Long-Term Outcome of Repetitive Transcranial Magnetic ...Conclusions: This is the first follow-up study to show that rTMS treatment is accompanied by long-lasting reductions in cocaine use in a large cohort.
Evidence for Safety and Tolerability of Transcranial Magnetic ...Forty-seven studies comprising 2,865 participants with a SUD were included. The prevalence of neck pain and cognitive impairment was higher for ...
Assessment and Management of Concurrent Substance ...Regarding safety, the most important consideration is the potential elevation of the risk of rTMS-induced seizures. For the management of ...
A systematic review and meta-analysis of neuromodulation ...Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (eg, craving, consumption, and relapse)
Repetitive Transcranial Magnetic Stimulation in Substance ...rTMS is generally considered safe when participants are properly screened and rTMS is applied within approved therapeutic protocols in many ...
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