rTMS for Cannabis Use Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?There has been a considerable rise in cannabis consumption in recent years, with estimates of 200 million individual users globally. Importantly, 3% of these individuals have cannabis use disorder (CUD), with this prevalence increasing to 33% amongst regular users, making it one of the most common substances use disorders (SUDs) worldwide. CUD is associated with substantial health, societal, and economic costs, and worsening of other psychiatric disorders. Despite this clinical burden, effective treatment options are limited. No pharmacological treatments have emerged as clearly efficacious, and psychotherapeutic interventions have shown tempered results.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of addictions. Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs, although research into cannabis has been largely unexplored. Recently, a novel circular rTMS coil, the MagVenture MMC-140, has been developed with the capacity to modulate both the bilateral prefrontal cortex (PFC) and insula, both of which are implicated in the neurocircuitry of craving and executive function. As such, it shows potential for CUD treatment.
This proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFC/insula using MMC-140 as a treatment for CUD. Feasibility of both high frequency (HF; excitatory) and low frequency (LF; inhibitory) stimulation parameters will be evaluated. In addition, pre/post rTMS changes in cannabis use outcomes (e.g., consumption, craving, and withdrawal), executive function, and PFC/insula functional connectivity will be explored. By comprehensively investigating clinical, cognitive, and neuroimaging effects of rTMS, this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel, cost-effective and accessible rTMS device.
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 data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for Cannabis Use Disorder?
Preliminary studies suggest that 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 as well.
12345Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans and has been used for various neuropsychiatric disorders. Studies have shown it is feasible to deliver rTMS to people with substance use disorders, although specific effects related to different levels of substance use are not well understood.
12456How is rTMS treatment different from other treatments for cannabis use disorder?
Repetitive Transcranial Magnetic Stimulation (rTMS) is a unique, non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, like the dorsolateral prefrontal cortex, to reduce cravings in substance use disorders. Unlike traditional therapies, rTMS does not involve medication and is still being explored as a novel option for cannabis use disorder, where few effective treatments currently exist.
12457Eligibility Criteria
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.
I understand the details of the clinical trial and can make decisions about my health.
+5 more
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
+4 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Group I: High-Frequency (HF)Active Control1 Intervention
10 Hz rTMS
Group II: Low-Frequency (LF)Active Control1 Intervention
1 Hz rTMS
Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada, Australia 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
🇦🇺 Approved in Australia as rTMS for:
- Major depressive disorder
- Obsessive-compulsive disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre for Addiction and Mental HealthToronto, Canada
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Who Is Running the Clinical Trial?
Centre for Addiction and Mental HealthLead Sponsor
Brain & Behavior Research FoundationCollaborator
References
A Preliminary Investigation Of Repetitive Transcranial Magnetic Stimulation Applied To The Left Dorsolateral Prefrontal Cortex In Treatment Seeking Participants With Cannabis Use Disorder. [2023]Cannabis use disorder (CUD) is a common and consequential disorder. When applied to the dorsolateral prefrontal cortex (DLPFC), repetitive transcranial magnetic stimulation (rTMS) reduces craving across substance use disorders and may have a therapeutic clinical effect when applied in serial sessions. The present study sought to preliminarily determine whether serial sessions of rTMS applied to the DLPFC had a therapeutic effect in CUD.
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]Cannabis use disorder (CUD) is a common and consequential disorder. When applied to the dorsolateral prefrontal cortex (DLPFC), repetitive transcranial magnetic stimulation (rTMS) reduces craving across substance use disorders and may have therapeutic clinical effects when applied in serial-sessions. The present study sought to preliminarily determine whether serial-sessions of rTMS applied to the DLPFC had a therapeutic effect in CUD.
Investigating repetitive transcranial magnetic stimulation on cannabis use and cognition in people with schizophrenia. [2022]Cannabis use disorder (CUD) occurs at high rates in schizophrenia, which negatively impacts its clinical prognosis. These patients have greater difficulty quitting cannabis which may reflect putative deficits in the dorsolateral prefrontal cortex (DLPFC), a potential target for treatment development. We examined the effects of active versus sham high-frequency (20-Hz) repetitive transcranial magnetic stimulation (rTMS) on cannabis use in outpatients with schizophrenia and CUD. Secondary outcomes included cannabis craving/withdrawal, psychiatric symptoms, cognition and tobacco use. Twenty-four outpatients with schizophrenia and CUD were enrolled in a preliminary double-blind, sham-controlled randomized trial. Nineteen participants were randomized to receive active (n = 9) or sham (n = 10) rTMS (20-Hz) applied bilaterally to the DLPFC 5x/week for 4 weeks. Cannabis use was monitored twice weekly. A cognitive battery was administered pre- and post-treatment. rTMS was safe and well-tolerated with high treatment retention (~90%). Contrast estimates suggested greater reduction in self-reported cannabis use (measured in grams/day) in the active versus sham group (Estimate = 0.33, p = 0.21; Cohen's d = 0.72), suggesting a clinically relevant effect of rTMS. A trend toward greater reduction in craving (Estimate = 3.92, p = 0.06), and significant reductions in PANSS positive (Estimate = 2.42, p = 0.02) and total (Estimate = 5.03, p = 0.02) symptom scores were found in the active versus sham group. Active rTMS also improved attention (Estimate = 6.58, p
Repetitive transcranial magnetic stimulation as a potential treatment approach for cannabis use disorder. [2022]The expanding legalization of cannabis across the United States is associated with increases in cannabis use, and accordingly, an increase in the number and severity of individuals with cannabis use disorder (CUD). The lack of FDA-approved pharmacotherapies and modest efficacy of psychotherapeutic interventions means that many of those who seek treatment for CUD relapse within the first few months. Consequently, there is a pressing need for innovative, evidence-based treatment development for CUD. Preliminary evidence suggests that repetitive transcranial magnetic stimulation (rTMS) may be a novel, non-invasive therapeutic neuromodulation tool for the treatment of a variety of substance use disorders (SUDs), including recently receiving FDA clearance (August 2020) for use as a smoking cessation aid in tobacco cigarette smokers. However, the potential of rTMS for CUD has not yet been reviewed. This paper provides a primer on therapeutic neuromodulation techniques for SUDs, with a particular focus on reviewing the current status of rTMS research in people who use cannabis. Lastly, future directions are proposed for rTMS treatment development in CUD, with suggestions for study design parameters and clinical endpoints based on current gold-standard practices for therapeutic neuromodulation research.
Repetitive transcranial magnetic stimulation (rTMS) administration to heavy cannabis users. [2023]Cannabis use disorder (CUD) is a common condition with few treatments. Several studies in other substance use disorders have found that applying repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) decreases cue-elicited craving and possibly decreases use. To date, there have been no studies attempting to use rTMS in CUD.
Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. [2023]Repetitive Transcranial Magnetic Stimulation (rTMS) is an invaluable treatment option for neuropsychiatric disorders. Co-occurring recreational and nonmedical substance use can be common in those presenting for rTMS treatment, and it is unknown how it may affect the safety and efficacy of rTMS for the treatment of currently approved neuropsychiatric indications. This scoping review aimed to map the literature on humans receiving rTMS and had a history of any type of substance use. The search identified 274 articles providing information on inclusion/exclusion criteria, withdrawal criteria, safety protocols, type of rTMS and treatment parameters, adverse events and effect on primary outcomes that related to substance use. There are neurophysiological effects of substance use on cortical excitability, although the relevance to clinical rTMS practice is unknown. The current literature supports the safety and feasibility of delivering rTMS to those who have co-occurring neuropsychiatric disorder and substance use. However, specific details on how varying degrees of substance use alters the safety, efficacy, and mechanisms of rTMS remains poorly described.
Repetitive transcranial magnetic stimulation and drug addiction. [2019]Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is now being tested for its ability to treat addiction. This review discusses current research approaches and results of studies which measured the therapeutic use of rTMS to treat tobacco, alcohol and illicit drug addiction. The research in this area is limited and therefore all studies evaluating the therapeutic use of rTMS in tobacco, alcohol or illicit drug addiction were retained including case studies through NCBI PubMed ( http://www.ncbi.nlm.nih.gov ) and manual searches. A total of eight studies were identified that examined the ability of rTMS to treat tobacco, alcohol and cocaine addiction. The results of this review indicate that rTMS is effective in reducing the level of cravings for smoking, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC). Furthermore, these studies suggest that repeated sessions of high frequency rTMS over the DLPFC may be most effective in reducing the level of smoking and alcohol consumption. Although work in this area is limited, this review indicates that rTMS is a promising modality for treating drug addiction.