rTMS for Cannabis Use Disorder

Overseen By Victor Tang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: Psychotropic medications

Must not be taking: Benzodiazepines, Anticonvulsants

Disqualifiers: Pregnancy, Bipolar, Schizophrenia, Seizure, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals with cannabis use disorder (CUD), which affects many regular cannabis users. The study tests a brain-based treatment called repetitive transcranial magnetic stimulation (rTMS), using magnetic fields to potentially reduce cravings and cannabis use. Participants will receive either high-frequency or low-frequency rTMS targeting specific brain areas involved in addiction. The trial seeks individuals who use cannabis frequently (at least 5 days a week) and wish to cut down or quit. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for CUD.

Will I have to stop taking my current medications?

The trial requires that you be on a stable regimen of your psychotropic medications for at least 14 days before joining. However, if you are taking more than 2 mg of lorazepam (or an equivalent dose of another benzodiazepine) or any anticonvulsant medication, you may need to stop or adjust those medications during the treatment.

What prior data suggests that this rTMS device is safe for treating cannabis use disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people with cannabis use disorder (CUD). Studies have found that rTMS is well-tolerated under approved conditions. This treatment uses magnetic fields to stimulate parts of the brain, which can help with cravings and addiction.

For high-frequency rTMS, research suggests it is safe and may benefit people with CUD, even those with conditions like schizophrenia. A review noted that rTMS treatments are practical and tolerable, though more research is needed to confirm their effectiveness.

Low-frequency rTMS is also considered safe for CUD. Studies report that participants tolerate the treatment well. While a single session might not reduce cravings, multiple sessions show promise in treating CUD.

Overall, both high-frequency and low-frequency rTMS appear safe for people with CUD, with minimal side effects when used correctly. This makes them promising options for those seeking new ways to manage cannabis use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about repetitive transcranial magnetic stimulation (rTMS) for cannabis use disorder because it offers a non-invasive alternative to traditional treatments like cognitive-behavioral therapy and medication. Unlike medication-based treatments, rTMS uses magnetic fields to stimulate specific areas of the brain, potentially reducing cravings and dependence without the need for pharmaceuticals. The study explores two approaches: high-frequency (10 Hz) and low-frequency (1 Hz) rTMS, which may provide insights into the most effective stimulation patterns for addressing cannabis use disorder. This innovative technique could lead to a new way to manage addiction with fewer side effects and a more targeted approach than conventional methods.

What evidence suggests that rTMS could be an effective treatment for cannabis use disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) could be a promising treatment for cannabis use disorder (CUD). This trial will compare two approaches: high-frequency (HF) rTMS and low-frequency (LF) rTMS. Studies have found that rTMS is safe and might help reduce cannabis use. Some research suggests that high-frequency rTMS may help decrease cannabis consumption, while low-frequency rTMS is also safe and could help with cravings. Although more research is needed, early results are encouraging for using rTMS to treat substance use disorders. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with cannabis use disorder, using cannabis at least 5 days a week and aiming to reduce or quit. They must have a certain level of dependency and be on stable psychiatric meds if any. Excluded are pregnant individuals, those with severe mental health disorders, other primary substance abuse issues, seizure history, significant head injury, unstable medical conditions, or specific medications.

Inclusion Criteria

I have been on the same mental health medication for at least 14 days.

I use cannabis most days of the week and want to reduce or stop using it.

Diagnosis of cannabis use disorder according to the DSM-5 and the Structured Clinical Interview for DSM-5 (SCID for DSM-5)

Exclusion Criteria

I have an active seizure disorder or a significant head injury with a confirmed lesion.

Pregnant or intending to be pregnant during the study

Presence of cardiac pacemaker, intracranial implant, or metal in the cranium

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week course of rTMS to the PFC/insula using MMC-140 for CUD treatment

4 weeks

Weekly visits for rTMS sessions

Follow-up

Participants are monitored for changes in cannabis use outcomes, executive function, and PFC/insula connectivity

4 weeks

Follow-up assessments at 4 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation

Trial Overview

The study tests repetitive transcranial magnetic stimulation (rTMS) using the MMC-140 coil on people with cannabis use disorder over four weeks. It will assess how well this non-invasive brain stimulation works in reducing cravings and consumption by exciting or inhibiting brain activity related to addiction.

How Is the Trial Designed?

Group I: High-Frequency (HF) Active Control 1 Intervention

10 Hz rTMS

Group II: Low-Frequency (LF) Active Control 1 Intervention

1 Hz rTMS

Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Migraines

Approved in European Union as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Anxiety disorders

Approved in Canada as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Brain & Behavior Research Foundation

Collaborator

Trials

63

Recruited

2,900+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) applied to the dorsolateral prefrontal cortex is safe and feasible for individuals with cannabis use disorder (CUD), based on a study involving 72 participants.

While there were no significant differences in craving reduction, those receiving active rTMS reported fewer days of cannabis use in the final two weeks of follow-up, suggesting potential therapeutic benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary randomized controlled trial of repetitive transcranial magnetic stimulation applied to the left dorsolateral prefrontal cortex in treatment seeking participants with cannabis use disorder. Sahlem, GL., Kim, B., Baker, NL., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) applied to the dorsolateral prefrontal cortex is safe and feasible for individuals with cannabis use disorder (CUD), based on a study involving 72 participants.

While there were no significant differences in craving reduction, those receiving active rTMS reported fewer days of cannabis use in the final two weeks of follow-up, suggesting potential therapeutic benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Investigation Of Repetitive Transcranial Magnetic Stimulation Applied To The Left Dorsolateral Prefrontal Cortex In Treatment Seeking Participants With Cannabis Use Disorder. Sahlem, GL., Kim, B., Baker, NL., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) can be safely and feasibly administered to individuals with cannabis use disorder (CUD), with 89% of participants completing the study without adverse effects.

However, a single session of rTMS did not significantly reduce cue-elicited craving for cannabis, suggesting that while the treatment is tolerable, it may not be effective for craving reduction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) administration to heavy cannabis users. Sahlem, GL., Baker, NL., George, MS., et al.[2023]

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe and feasible for patients with neuropsychiatric disorders who also have a history of substance use, based on a review of 274 articles.

However, the impact of different levels of substance use on the safety and efficacy of rTMS remains unclear, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. Tang, VM., Ibrahim, C., Rodak, T., et al.[2023]

The rise in cannabis use and cannabis use disorder (CUD) due to increased legalization highlights the urgent need for effective treatments, as current options have limited success and high relapse rates.

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment for substance use disorders, including CUD, and has received FDA clearance for smoking cessation, indicating its potential for broader applications in addiction therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation as a potential treatment approach for cannabis use disorder. Kearney-Ramos, T., Haney, M.[2022]

In a preliminary study involving 24 outpatients with schizophrenia and cannabis use disorder, high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the dorsolateral prefrontal cortex was found to be safe and well-tolerated, with a high retention rate of about 90%.

The active rTMS group showed a trend towards reduced cannabis use and craving, along with significant improvements in psychiatric symptoms and attention, suggesting that rTMS may be an effective treatment option for cannabis use disorder in patients with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating repetitive transcranial magnetic stimulation on cannabis use and cognition in people with schizophrenia. Bidzinski, KK., Lowe, DJE., Sanches, M., et al.[2022]

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]

Citations

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rTMS in the Treatment of Drug Addiction - PubMed Central - NIH

rTMS is a noninvasive brain stimulation technique that has been assessed in a growing number of studies for its therapeutic potential in treating addiction.

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Interventional Model Description: Participants will be randomized to one of two groups to receive either high-frequency (10 Hz) or low-frequency (1 Hz) rTMS.

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