TMS for Drug Addiction

Overseen By NIDA IRP Screening Team

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: Psychotropic, Anticonvulsants

Disqualifiers: Stroke, Seizures, Neurological disorders, others

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: 8

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how transcranial magnetic stimulation (TMS), a non-invasive brain therapy, affects brain activity. TMS is already used to treat depression and might reduce drug cravings, potentially serving as a future treatment for drug addiction. The trial involves stimulating the front part of the brain and observing the effects on that area and connected regions. It seeks healthy, right-handed adults who do not use drugs and have no history of substance use disorders. As an unphased trial, participants can contribute to groundbreaking research that could lead to new treatments for drug addiction.

Will I have to stop taking my current medications?

The trial requires that participants do not use any medications with psychotropic (mind-affecting), anti-convulsive, or pro-convulsive actions in the past 4 weeks or chronically in the past 6 months. If you are taking such medications, you may need to stop them to participate.

What prior data suggests that TMS is safe for non-drug users?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. A review of 141 clinical trials found TMS safe for individuals with substance use disorders. Studies indicate that participants typically experience only minor side effects, such as headaches or scalp discomfort.

TMS has already received approval for treating depression, which supports its safety. While researchers are studying TMS for new uses, such as reducing drug cravings, its established safety in treating depression suggests it is a dependable option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, offering a non-invasive approach to treating drug addiction. Unlike traditional treatments like medication-assisted therapies (such as methadone or buprenorphine) or behavioral therapies, TMS directly targets the brain's activity patterns that contribute to addiction. Researchers are excited about TMS because it has the potential to provide rapid effects without the need for medication, which can be especially beneficial for individuals who have not responded well to existing therapies.

What evidence suggests that TMS might be an effective treatment for drug addiction?

Research has shown that transcranial magnetic stimulation (TMS) can help reduce cravings in people with drug addiction. Studies have found that TMS significantly lowers craving scores and reduces substance use. In one study, participants who received TMS treatment experienced long-lasting reductions in cocaine use. Additionally, TMS decreases impulsivity and risk-taking behaviors, which are often linked to addiction. These findings suggest TMS could be a promising tool for managing drug addiction. Participants in this trial will receive TMS to investigate its acute effects on brain activity related to addiction. ^{4 5 6 7 8}

Who Is on the Research Team?

Yihong Yang, Ph.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Are You a Good Fit for This Trial?

This trial is for healthy, right-handed adults aged 18-60 who don't use drugs. Participants must not have a history of neurological disorders, heart conditions, metal implants in the head, or severe hearing loss. Pregnant women and those not using contraception are excluded.

Inclusion Criteria

We cannot include people with certain medical conditions because it may affect their brain function and the results of the fMRI scan.

You should be generally healthy.

I am in good overall health.

Exclusion Criteria

I have hearing loss or ringing in my ears due to loud noise.

A close family member has a hereditary neurological disorder like migraines, epilepsy, or MS.

I have a history of significant neurological issues, including stroke, seizures, or major head injuries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

TMS Orientation

Participants will have a TMS orientation visit where a wire coil is placed on the head to create a magnetic pulse that stimulates the brain.

1 visit (3 hours)

1 visit (in-person)

TMS-MRI Sessions

Participants will undergo up to 6 TMS-fMRI sessions over three days to evaluate TMS induced changes in brain activity.

3 days

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through a follow-up call 2-3 weeks after their last session.

2-3 weeks

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• TMS

Trial Overview

The study tests how Transcranial Magnetic Stimulation (TMS) affects brain activity. It involves placing a coil on the head to stimulate the brain with magnetic pulses while undergoing MRI scans to observe changes.

How Is the Trial Designed?

Group I: TMS Experimental Treatment 1 Intervention

All participants will receive TMS to investigate acute modulations of brain activity by TMS

TMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in European Union as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) is emerging as a promising noninvasive treatment for substance dependence, potentially filling a gap in addiction therapies, as it is already FDA-approved for depression.

Repetitive TMS (rTMS) has shown potential in altering behavior and brain activity related to addiction, and future studies may benefit from combining rTMS with medications and cognitive behavioral therapies to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating Neural Circuits with Transcranial Magnetic Stimulation: Implications for Addiction Treatment Development. Hanlon, CA., Dowdle, LT., Henderson, JS.[2019]

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive treatment recently approved for smoking cessation, showing promise in reducing cravings and consumption in various substance use disorders (SUDs).

The therapeutic efficacy of rTMS is thought to involve modulation of neural circuits related to executive control and salience, particularly targeting areas like the dorsolateral prefrontal cortex (DLPFC) and insula, although further research is needed to explore its potential direct effects on dopamine pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation as a Tool to Promote Smoking Cessation and Decrease Drug and Alcohol Use. Harmelech, T., Hanlon, CA., Tendler, A.[2023]

Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique that has shown promise as a safe and cost-effective treatment for substance use disorders (SUDs), impacting neural activity and promoting neuroplasticity.

Evidence from both preclinical and clinical studies supports the efficacy of repetitive TMS in modulating the brain circuitry associated with addiction, suggesting it could be a valuable intervention for treating SUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rewiring the Addicted Brain: Circuits-Based Treatment for Addiction. Madeo, G., Bonci, A.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has shown effectiveness in reducing cravings for tobacco, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC), based on a review of eight studies.

Repeated sessions of high-frequency rTMS over the DLPFC may be particularly beneficial for decreasing smoking and alcohol consumption, suggesting that rTMS could be a promising treatment option for drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. Barr, MS., Farzan, F., Wing, VC., et al.[2019]

Transcranial magnetic stimulation (TMS) has been explored in 19 studies involving 316 adults for its potential to reduce drug cravings and use, particularly targeting the dorsolateral prefrontal cortex with high-frequency pulses.

While some studies showed promising results, such as decreased smoking and cocaine use, the treatment is still experimental, and the exact mechanisms and optimal parameters for rTMS in addiction treatment remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of substance addiction. Gorelick, DA., Zangen, A., George, MS.[2022]

Excitatory repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral pre-frontal cortex significantly reduces craving for substances in patients with dependence, with a strong effect size (Hedges' g = -0.62) based on a meta-analysis of 26 randomized controlled trials involving 748 participants.

In addition to reducing cravings, rTMS also effectively decreases substance consumption, particularly when using excitatory stimulation protocols, indicating its potential as a therapeutic intervention for substance dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Zhang, JJQ., Fong, KNK., Ouyang, RG., et al.[2020]

In a randomized clinical trial with 30 methamphetamine-addicted patients, real rTMS significantly reduced cue-induced craving after 5 sessions compared to sham stimulation.

Real rTMS also improved cognitive functions such as verbal learning and memory, indicating it is a safe and effective intervention for reducing cravings in methamphetamine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. Su, H., Zhong, N., Gan, H., et al.[2022]

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