TMS for Methamphetamine Abuse

Overseen By Sooraj John, M.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Carilion Clinic

Disqualifiers: Alcohol use, Benzodiazepine use

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm.

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.

What data supports the effectiveness of this treatment for methamphetamine abuse?

Research shows that intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS), can significantly reduce cravings and improve cognitive function in people with methamphetamine use disorder. Additionally, iTBS has been found to be as effective as traditional repetitive TMS in reducing drug cravings, suggesting it may be a promising treatment option. ^{1 2 3 4 5}

Is TMS safe for treating methamphetamine addiction?

Research suggests that TMS, including its variations like iTBS and rTMS, is generally safe for treating methamphetamine addiction, with studies showing it can reduce cravings and improve cognitive function without significant safety concerns. ^{1 3 4 5 6}

How is Theta Burst TMS treatment different from other treatments for methamphetamine abuse?

Theta Burst TMS is a non-invasive brain stimulation treatment that uses magnetic fields to reduce cravings and improve cognitive function in methamphetamine users. Unlike traditional treatments, it specifically targets the brain's dorsolateral prefrontal cortex and is administered in short, daily sessions, making it a novel approach for managing methamphetamine addiction. ^{3 4 5 6 7}

Research Team

Sooraj John, M.D.

Principal Investigator

Carilion Clinic

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Theta Burst TMS (Behavioural Intervention)

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.

Participant Groups

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 China for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation vs. High-Frequency Repetitive Transcranial Magnetic Stimulation in the Treatment of Methamphetamine Patients. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. [2023]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Emergence of Sexual Dreams and Emission Following Deep Transcranial Magnetic Stimulation over the Medial Prefrontal and Cingulate Cortices. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A transcranial magnetic stimulation protocol for decreasing the craving of methamphetamine-dependent patients. [2022]