Deep TMS for Methamphetamine Addiction

Overseen By Eileen G Fischer, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Benzodiazepines, Neuroleptics

Disqualifiers: Seizure disorder, Bipolar, Psychosis, others

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

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether deep transcranial magnetic stimulation (dTMS) can assist Veterans struggling with methamphetamine addiction. Participants will receive either the actual dTMS treatment or a sham version to compare results. Veterans with moderate to severe methamphetamine use disorder who can commit to frequent clinic visits may be suitable candidates. The goal is to determine if dTMS can reduce methamphetamine use and enhance overall well-being. As an unphased trial, this study offers Veterans the chance to contribute to groundbreaking research that could lead to new treatment options for methamphetamine addiction.

Will I have to stop taking my current medications?

If you are on a stable medication regimen for other symptoms, you can continue taking those medications during the study. However, you must stop taking any medications that increase seizure risk at least two weeks before starting the treatment.

What prior data suggests that deep transcranial magnetic stimulation (dTMS) is safe for treating methamphetamine use disorder?

Research has shown that deep transcranial magnetic stimulation (dTMS) is generally safe for people with methamphetamine use disorder (MUD). Several studies have used dTMS safely, reporting only a few minor side effects. These side effects are usually mild, such as headaches or scalp discomfort, and they typically resolve on their own.

Overall, past research considers dTMS a safe option for those with MUD. While no treatment is completely without risk, dTMS has demonstrated a low rate of serious side effects. This makes it a promising choice for those considering participation in trials for methamphetamine addiction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Transcranial Magnetic Stimulation (dTMS) for methamphetamine addiction because it offers a non-invasive approach that directly targets brain regions involved in addiction. Unlike traditional treatments like behavioral therapy and medication, dTMS uses magnetic fields to modulate neural activity, potentially reducing cravings and improving self-control. This technique can be administered quickly, with each session lasting about 30 minutes, and it holds promise for delivering results over a short period, which is crucial for individuals struggling with addiction.

What evidence suggests that deep transcranial magnetic stimulation (dTMS) might be an effective treatment for methamphetamine addiction?

Research has shown that deep transcranial magnetic stimulation (dTMS) can help reduce drug cravings in people with methamphetamine addiction. In this trial, participants will join one of two groups: one receiving active dTMS and the other receiving sham dTMS. One study found that dTMS greatly improved self-control in those who had stopped using methamphetamine. Another review found that dTMS effectively lowered cravings and relapse rates. These findings suggest that dTMS may be a promising treatment for methamphetamine addiction by targeting specific brain areas linked to addiction. ^{3 6 7 8 9}

Who Is on the Research Team?

Michelle R Madore, PhD

Principal Investigator

Stanford University

Claudia B Padula, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for veterans struggling with methamphetamine addiction. Participants should be seeking treatment and have no other major health issues that could interfere with the study.

Inclusion Criteria

Participants must meet DSM-5 criteria for moderate to severe MUD (≥4 diagnostic symptoms)

Participants must be able to obtain a Motor Threshold (MT) during the screening process

I am between 25 and 75 years old.

Exclusion Criteria

Severe impediment to vision, hearing and/or hand movement likely to interfere with the ability to follow study protocols

I have not attempted suicide nor planned it in the last 30 days.

I am taking medication that affects seizure risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 active or sham dTMS treatments, administered 3 times per day over 10 consecutive business days

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for methamphetamine use outcomes and salience network function

3 months

Follow-up assessments at 1-4 days and 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Deep Transcranial Magnetic Stimulation (dTMS)

Trial Overview

The study tests deep transcranial magnetic stimulation (dTMS) using an H4 coil. Some participants will receive real dTMS, while others get a sham (fake) treatment to compare outcomes.

How Is the Trial Designed?

Group I: Active dTMS Experimental Treatment 1 Intervention

Participants will receive 30 active dTMS treatments, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

Group II: Sham dTMS Placebo Group 1 Intervention

Participants will receive 30 sham dTMS sessions, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Published Research Related to This Trial

A study involving 60 participants with severe methamphetamine use disorder found that 20 sessions of intermittent theta burst rTMS significantly reduced drug cravings and induced neuroplastic changes in brain connectivity.

The reduction in craving was linked to increased functional connectivity between the left dorsolateral prefrontal cortex and the inferior parietal lobule, suggesting that rTMS may help rewire brain networks involved in addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving. Su, H., Liu, Y., Yin, D., et al.[2021]

High-frequency repetitive transcranial magnetic stimulation (rTMS) significantly reduced drug craving in patients with methamphetamine use disorder, as evidenced by lower Visual Analog Scale (VAS) scores compared to the sham group.

The 10-Hz rTMS group also showed improved decision-making abilities on the Iowa Game Test (IGT), particularly in later blocks, indicating that rTMS may enhance cognitive function in addition to reducing cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex reduces drug craving and improves decision-making ability in methamphetamine use disorder. Wang, W., Zhu, Y., Wang, L., 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]

In a study involving 97 patients with severe methamphetamine use disorder (MUD), those who had better cognitive and emotional functioning were more likely to respond positively to repetitive transcranial magnetic stimulation (rTMS) treatment, indicating that these factors can help predict treatment outcomes.

Patients with MUD exhibited significant cognitive impairments and emotional disturbances compared to healthy controls, suggesting that addressing these issues may enhance the effectiveness of rTMS in reducing drug cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and emotional predictors of real versus sham repetitive transcranial magnetic stimulation treatment response in methamphetamine use disorder. Chen, T., Su, H., Jiang, H., et al.[2021]

Low-frequency repetitive transcranial magnetic stimulation (rTMS) effectively blocked methamphetamine-induced conditioned place preference in rats, suggesting its potential to inhibit the development of methamphetamine addiction.

The mechanism behind this effect involves a downregulation of GABABR1 expression in the dorsolateral striatum, indicating a specific neurobiological target for rTMS in treating drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-frequency repetitive transcranial magnetic stimulation inhibits the development of methamphetamine-induced conditioned place preference. Wu, XQ., Zan, GY., Ju, YY., et al.[2019]

High-frequency repetitive transcranial magnetic stimulation (rTMS) at 10 Hz applied to the left dorsolateral prefrontal cortex (DLPFC) significantly improved behavioral adjustment in long-term methamphetamine (METH) addicts by reducing the post-error slowing effect in their response times.

After rTMS treatment, the response times of METH addicts during post-error trials became comparable to those of healthy individuals, indicating that this intervention may help restore normal cognitive functioning related to error processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention Effect of Repetitive TMS on Behavioral Adjustment After Error Commission in Long-Term Methamphetamine Addicts: Evidence From a Two-Choice Oddball Task. Liang, Q., Lin, J., Yang, J., et al.[2019]

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]

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