TMS for Methamphetamine Abuse

Overseen By Sooraj John, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Alcohol use, Benzodiazepine use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Transcranial Magnetic Stimulation (TMS), a non-invasive brain treatment, can aid individuals with Methamphetamine Use Disorder. Participants will be randomly assigned to one of two groups: one receiving real TMS treatments and the other receiving a sham (fake) treatment for comparison. It suits individuals actively dealing with Methamphetamine Use Disorder who are also part of the Carilion Clinic's addiction treatment program. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in addiction treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be enrolled in a specific addiction treatment program, which may have its own medication guidelines.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Theta Burst Transcranial Magnetic Stimulation (TMS) is generally safe. Patients in studies handled the treatment well, with few reports of serious side effects. Some experienced mild headaches or discomfort at the treatment site, but these effects were temporary and manageable.

One study comparing different TMS methods found that intermittent Theta Burst Stimulation (iTBS) was safe and helped reduce methamphetamine cravings. Another study confirmed that TMS could be a promising option for treating addiction by targeting specific brain areas.

Overall, the treatment appears safe, with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Theta Burst Transcranial Magnetic Stimulation (TMS) for methamphetamine abuse because it offers a non-invasive approach that directly targets brain activity. Unlike current treatments, which often rely on behavioral therapy and medications to manage withdrawal symptoms, TMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing cravings and improving self-control. This unique mechanism of action could provide a faster and more effective way to address the neurological aspects of addiction, offering hope for more immediate relief for those struggling with methamphetamine dependence.

What evidence suggests that TMS might be an effective treatment for Methamphetamine Use Disorder?

Research has shown that Theta Burst Transcranial Magnetic Stimulation (TMS) could help treat Methamphetamine Use Disorder. In this trial, participants will join different arms, with one group receiving actual TMS treatments. Studies suggest this method might reduce cravings and improve self-control in those struggling with methamphetamine addiction. It uses magnetic pulses to stimulate brain areas linked to addiction. Early results indicate that patients receiving Theta Burst TMS experience fewer withdrawal symptoms and feel less urge to use methamphetamine. Although more research is needed to confirm these findings, the initial evidence is promising for those seeking new treatment options. ^{1 3 4 5 6}

Who Is on the Research Team?

Sooraj John, M.D.

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for individuals struggling with Methamphetamine Use Disorder. Participants will be randomly assigned to receive either real TMS treatment or a sham (placebo) version over five consecutive sessions.

Inclusion Criteria

Individuals actively struggling with Methamphetamine Use Disorder

Must be currently enrolled in Carilion Clinic Office Based Addiction Treatment (OBAT) program

Exclusion Criteria

Individuals currently struggling with alcohol use and/or benzodiazepine use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive 5 consecutive TMS or sham-TMS treatment sessions

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Theta Burst TMS

Trial Overview The study is testing the effectiveness of Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique, in treating Methamphetamine Use Disorder compared to a sham procedure that mimics TMS without active treatment.

How Is the Trial Designed?

Group I: Transcranial Magnetic Stimulation (TMS) Experimental Treatment 1 Intervention

This arm receives the TMS treatments.

Group II: Sham-TMS Placebo Group 1 Intervention

This arm receives sham TMS treatments.

Theta Burst TMS is already approved in United States, European Union, China for the following indications:

Approved in United States as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Migraine with aura

Approved in European Union as Repetitive Transcranial Magnetic Stimulation (rTMS) for:

• Major Depressive Disorder
• Obsessive-Compulsive Disorder

Approved in China as Theta Burst Stimulation (TBS) for:

• Methamphetamine Use Disorder (experimental)
• Depression

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

Intermittent theta burst repetitive transcranial magnetic stimulation (iTBS-rTMS) significantly reduced cravings, impulsivity, anxiety, and depression in 50 patients with methamphetamine use disorder (MUD) compared to a sham treatment group after 20 sessions.

Baseline impulsivity and improvements in depression were found to predict the effectiveness of iTBS-rTMS treatment, with a specific reduction rate in depression showing strong predictive power for therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive role of impulsivity, anxiety, and depression in the efficacy of intermittent theta burst transcranial magnetic stimulation modalities for treating methamphetamine use disorder: A randomized clinical trial. Ren, Z., Mu, L., Wang, L., et al.[2023]

Intermittent theta burst stimulation (iTBS) and conventional 10 Hz repetitive transcranial magnetic stimulation (rTMS) showed similar effectiveness in reducing drug cravings and improving withdrawal symptoms in 20 male patients with methamphetamine use disorder (MAUD) after 12 treatments.

Both treatment methods were effective, suggesting that iTBS could be a viable alternative to 10 Hz rTMS, potentially enhancing the accessibility and cost-effectiveness of treatment for MAUD, although further large-scale studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation vs. High-Frequency Repetitive Transcranial Magnetic Stimulation in the Treatment of Methamphetamine Patients. Liu, Q., Sun, H., Hu, Y., et al.[2022]

Intermittent theta burst stimulation (iTBS) over the left DLPFC and continuous theta burst stimulation (cTBS) over the right DLPFC significantly reduced cue-induced craving in abstinent methamphetamine-dependent subjects, indicating their potential efficacy as treatments for addiction.

The study involved 83 participants and showed that while iTBS had higher self-reported adverse effects initially, both stimulation methods were feasible and tolerable, suggesting a promising approach to reduce craving with shorter treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. Zhao, D., Li, Y., Liu, T., et al.[2023]

Transcranial magnetic stimulation (TMS) is a promising non-invasive technique that may help reduce cravings and the risk of relapse in individuals with substance use disorders, particularly methamphetamine use disorders.

The study introduces three alternative TMS settings designed specifically to target and regulate brain function related to methamphetamine addiction, suggesting potential for broader application in similar brain-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transcranial magnetic stimulation protocol for decreasing the craving of methamphetamine-dependent patients. Chen, T., Su, H., Li, R., et al.[2022]

A proof-of-concept study involving 19 individuals with cocaine use disorder showed that administering intermittent theta-burst stimulation (iTBS) to the left dorsolateral prefrontal cortex was well-tolerated and safe, even in participants actively using cocaine.

Participants who completed at least 26 of the 30 iTBS sessions reduced their weekly cocaine use by 78% in spending and 70% in frequency, indicating that iTBS may effectively modulate addiction-related circuits and reduce substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study. Steele, VR., Maxwell, AM., Ross, TJ., et al.[2020]

Intermittent theta burst stimulation (iTBS) applied over the dorsolateral prefrontal cortex (DLPFC) significantly reduced craving for methamphetamine and improved cognitive function and sleep quality in 126 participants with severe methamphetamine use disorder over a four-week period.

The study suggests that rTMS is a promising and safe treatment option for methamphetamine use disorder, indicating the need for further large-scale trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial. Su, H., Chen, T., Jiang, H., et al.[2021]

In a pilot study of methamphetamine dependents, 20 sessions of deep Transcranial Magnetic Stimulation (dTMS) over 4 weeks showed potential for behavioral changes related to addiction.

Interestingly, one patient experienced significant increases in sexual dreams and emissions, suggesting that dTMS may alter cortical excitability in unexpected ways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergence of Sexual Dreams and Emission Following Deep Transcranial Magnetic Stimulation over the Medial Prefrontal and Cingulate Cortices. Shen, Y., Cao, X., Zeng, NN., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9197111/

Efficacy of Repetitive Transcranial Magnetic Stimulation in ... Initially, students and young workers abuse methamphetamine because it could improve their performance by last their study and working time. However, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06372288

Theta Burst TMS for Treatment of Methamphetamine Use ... Methamphetamine Abuse. Methamphetamine Abuse. Methamphetamine Abuse ... Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.03.24.25324326v1.full-text

Theta Burst Stimulation in Patients With Methamphetamine ... The United States is in the grip of an unprecedented drug abuse and overdose crisis (1). Psychostimulant use, primarily methamphetamine, was the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124002804

Transcranial magnetic stimulation for methamphetamine ... Review article. Transcranial magnetic stimulation for methamphetamine use disorder: A scoping review within the neurocircuitry model of addiction.

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.842947/full

Intermittent Theta Burst Stimulation vs. High-Frequency ... Keywords: methamphetamine use disorder, iTBS, rTMS, substance abuse, addiction. Citation: Liu Q, Sun H, Hu Y, Wang Q, Zhao Z, Dong D and Shen ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11080215/

Pilot study with randomised control of dual site theta burst ... This study examines the feasibility of novel TMS protocols for the treatment of methamphetamine (MA) use disorder in an ambulatory drug and alcohol treatment ...