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

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with a methamphetamine use disorder (MUD).

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 data supports the effectiveness of the treatment Deep Transcranial Magnetic Stimulation (dTMS) for methamphetamine addiction?

Research on a similar treatment, repetitive transcranial magnetic stimulation (rTMS), shows it can reduce drug cravings and improve decision-making in people with methamphetamine addiction. This suggests that dTMS, which is a related technique, might also be effective. ^{1 2 3 4 5}

Is Deep TMS safe for methamphetamine addiction treatment?

Deep Transcranial Magnetic Stimulation (dTMS) is generally considered safe, but in a study, it was noted to cause increased sexual dreams and emissions in a patient. This suggests it can alter brain activity, but no severe safety concerns were reported. ^{1 2 3 5 6}

How is the Deep TMS treatment different from other treatments for methamphetamine addiction?

Deep Transcranial Magnetic Stimulation (dTMS) is unique because it targets specific brain areas, like the medial prefrontal and cingulate cortices, using magnetic fields to alter brain activity, which is different from traditional drug treatments. This non-invasive approach may help reduce addiction-related behaviors by changing how the brain functions, offering a novel option for methamphetamine addiction where standard treatments are limited. ^{1 2 3 5 7}

Research Team

Claudia B Padula, PhD

Principal Investigator

Stanford University

Michelle R Madore, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving. [2021]

2. Ireland 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive and emotional predictors of real versus sham repetitive transcranial magnetic stimulation treatment response in methamphetamine use disorder. [2021]

4. Singapore 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. [2019]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Low-frequency repetitive transcranial magnetic stimulation inhibits the development of methamphetamine-induced conditioned place preference. [2019]

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

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