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

Trial Summary

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 data supports the effectiveness of the treatment TMS for drug addiction?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help reduce cravings and substance use in people with addictions, including smoking and cocaine use. It works by stimulating certain brain areas involved in addiction, and while more studies are needed, it shows promise as a safe and cost-effective treatment. ^{1 2 3 4 5}

Is TMS safe for treating drug addiction?

TMS, including its repetitive form (rTMS), is generally considered safe for humans and has been used in various studies for treating addiction to substances like tobacco, alcohol, and cocaine. While it is still experimental for addiction, it is a noninvasive method and has been shown to be safe in other conditions. ^{1 3 4 5 6}

How is TMS treatment different from other treatments for drug addiction?

TMS (Transcranial Magnetic Stimulation) is unique because it is a non-invasive, drug-free treatment that uses magnetic fields to stimulate specific areas of the brain involved in addiction, such as the dorsolateral prefrontal cortex. Unlike traditional treatments, TMS targets neural circuits directly to reduce cravings and substance use, making it a promising option for those seeking alternatives to medication-based therapies. ^{1 3 4 6 7}

What is the purpose of this trial?

Background: Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction. Objectives: To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas. Eligibility: Healthy, right-handed adults ages 18-60 who are non-drug users. Design: Participants will be screened under protocol 06-DA-N415. Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit. Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires. Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain. The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation. Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 2-3 weeks after their last session. ...

Research Team

Yihong Yang, Ph.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation as a Tool to Promote Smoking Cessation and Decrease Drug and Alcohol Use. [2023]

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

Modulating Neural Circuits with Transcranial Magnetic Stimulation: Implications for Addiction Treatment Development. [2019]

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

Transcranial magnetic stimulation in the treatment of substance addiction. [2022]

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

Rewiring the Addicted Brain: Circuits-Based Treatment for Addiction. [2019]

5. England 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. [2019]

7. Ireland 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. [2022]