Deep Transcranial Magnetic Stimulation for Cannabis Use Disorder

(TRANS-CANN Trial)

Overseen By Dante Duarte, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Bupropion, Benzodiazepines

Disqualifiers: Schizophrenia, Bipolar, PTSD, others

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

Compensation: Varies

Number of Visits: 18

Duration: 4-6 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

There is a credible basis for lateral prefrontal cortex and insula deep repetitive transcranial magnetic stimulation (dTMS) stimulation as a treatment for cannabis use disorder (CUD), but no studies to date have examined this. Evidence of benefit could expand the treatment options available for CUD but require randomized controlled trials (RCTs) to evaluate its efficacy. Toward an RCT of this intervention, the proposed study is a phase 1 open-label pilot trial of dTMS for adults with CUD. This study will establish the viability of an H4 protocol constituting an active arm of a future double-blind RCT.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it does mention that certain medications, like high doses of bupropion or benzodiazepines, are not allowed due to safety concerns. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of this treatment for cannabis use disorder?

Preliminary studies suggest that repetitive transcranial magnetic stimulation (rTMS), when applied to a specific brain area called the dorsolateral prefrontal cortex, may help reduce cravings and cannabis use in people with cannabis use disorder. This treatment has shown promise in reducing cravings for other substance use disorders and has been approved for smoking cessation, indicating its potential effectiveness. ^{1 2 3 4 5}

Is deep transcranial magnetic stimulation safe for humans?

Repetitive transcranial magnetic stimulation (rTMS), which is similar to deep transcranial magnetic stimulation, has been found to be safe and well-tolerated in studies, including those involving people with cannabis use disorder and schizophrenia. Participants generally experienced high treatment retention, indicating that the procedure is manageable for most people. ^{1 3 4 5 6}

How is deep transcranial magnetic stimulation different from other treatments for cannabis use disorder?

Deep transcranial magnetic stimulation (dTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, like the dorsolateral prefrontal cortex, which may help reduce cravings and cannabis use. Unlike traditional therapies, it does not involve medication and has shown promise in treating other substance use disorders. ^{1 3 4 5 7}

Eligibility Criteria

This trial is for adults aged 25-65 with moderate to severe Cannabis Use Disorder (CUD), who use cannabis daily, mostly by smoking dried flower. Participants must want to change their habits, have a stable place to live and reliable transportation. They should also have certain levels of THC in their urine.

Inclusion Criteria

4 or more days of cannabis use per week

I am ready and willing to start treatment.

Stable domicile and reliable transportation, and willingness to attend in-person visits at SJHH Hamilton.

Exclusion Criteria

Active suicidality (past 3 months) or history of severe suicidality (i.e., requiring hospitalization)

Any other mental health condition deemed incompatible by the team

I am not on high doses of certain medications like bupropion or benzodiazepines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 18 H4 dTMS sessions over 4-6 weeks as an adjunct to evidence-based standard care for CUD

4-6 weeks

18 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cannabis use frequency and cravings

4 weeks

Follow-up

Participants are monitored for long-term effects, including cannabis use frequency and cravings

1 month

Treatment Details

Interventions

• Deep Repetitive Transcranial Magnetic Stimulation

Trial Overview The study tests deep repetitive transcranial magnetic stimulation (dTMS) using an H4 coil on the brain's lateral prefrontal cortex and insula as a potential treatment for CUD. It's an early-phase trial meant to set up for a larger future study where treatments are compared without participants knowing which one they're getting.

Participant Groups

Group I: H4 dTMS Experimental Treatment 1 Intervention

The participants will receive 18 H4 dTMS sessions over 4-6 weeks as an adjunct to evidence-based standard care for CUD (i.e., motivational interviewing and contingency management).

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Findings from Research

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]

In a study involving participants with schizophrenia, high-frequency rTMS applied to the dorsolateral prefrontal cortex over 4 weeks showed that better baseline cognitive performance in sustained attention and complex planning was linked to greater reductions in cannabis use among those receiving active treatment.

While rTMS improved cognitive functions like complex planning and sustained attention, the changes in these cognitive abilities did not mediate the reduction in cannabis use, suggesting that rTMS may directly influence cannabis use independently of cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive moderation of repetitive transcranial magnetic stimulation (rTMS) effects on cannabis use in schizophrenia: a preliminary analysis. Johnstone, S., Lowe, DJE., Kozak-Bidzinski, K., et al.[2022]

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]

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]

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]

The ongoing study combines THC administration with TMS to investigate how stimulating the left dorsolateral prefrontal cortex (DLPFC) affects cognitive outcomes in individuals with problematic cannabis use, aiming to clarify the relationship between brain function and addiction-related behaviors.

This research seeks to enhance our understanding of how acute neuromodulation via TMS can influence the subjective and performance-related effects of THC, potentially revealing new insights into the neural mechanisms underlying substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining noninvasive brain stimulation with behavioral pharmacology methods to study mechanisms of substance use disorder. Wesley, MJ., Lile, JA.[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]

References

1. United States 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. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Neurocognitive moderation of repetitive transcranial magnetic stimulation (rTMS) effects on cannabis use in schizophrenia: a preliminary analysis. [2022]

3. Ireland 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Investigating repetitive transcranial magnetic stimulation on cannabis use and cognition in people with schizophrenia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation as a potential treatment approach for cannabis use disorder. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Combining noninvasive brain stimulation with behavioral pharmacology methods to study mechanisms of substance use disorder. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) administration to heavy cannabis users. [2023]