Deep Transcranial Magnetic Stimulation for Cannabis Use Disorder
(TRANS-CANN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Joseph's Healthcare Hamilton
Must not be taking: Bupropion, Benzodiazepines
Disqualifiers: Schizophrenia, Bipolar, PTSD, others
No Placebo Group
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.
12345Is 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.
13456How 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.
13457Eligibility 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.
+3 more
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.
+8 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: H4 dTMSExperimental Treatment1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Joseph's Healthcare HamiltonHamilton, Canada
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Who Is Running the Clinical Trial?
St. Joseph's Healthcare HamiltonLead Sponsor
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.
Neurocognitive moderation of repetitive transcranial magnetic stimulation (rTMS) effects on cannabis use in schizophrenia: a preliminary analysis. [2022]Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment for cannabis use disorder in schizophrenia; however, gaps in the literature remain as to the potential role of neurocognitive functioning in treatment response. We evaluated the moderating role of select cognitive functions including baseline executive functioning, verbal memory, and sustained attention, and we explore the mediating role of changes in task performance on changes in cannabis use in both active and sham rTMS groups. Participants underwent high-frequency (20 Hz) rTMS applied to the bilateral dorsolateral prefrontal cortex 5x/week for 4 weeks. Weekly self-report of cannabis use and semi-quantitative urinary carboxy-tetrahydrocannabinol levels were recorded. A neurocognitive battery assessing verbal memory, visuospatial working memory, verbal working memory, sustained attention, delayed discounting, and complex planning was administered pre- and post-treatment. Better baseline performance on tasks assessing sustained attention, delayed discounting, and complex planning moderated the extent to which participants in the active group reduced cannabis use. There were no significant indirect pathways between treatment, changes in neuropsychological performance, and changes in cannabis use; however, active rTMS improved complex planning and sustained attention. These preliminary findings suggest that there is a moderating role of sustained attention, delayed discounting, and complex planning on the effects of rTMS on cannabis use. Further, mediation models suggest rTMS may exert direct effects on cannabis use independent of its effects on cognitive functioning in people with SCZ. Trial Registration: clinicaltrials.gov: NCT03189810.
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.
Combining noninvasive brain stimulation with behavioral pharmacology methods to study mechanisms of substance use disorder. [2023]Psychotropic drugs and transcranial magnetic stimulation (TMS) are effective for treating certain psychiatric conditions. Drugs and TMS have also been used as tools to explore the relationship between brain function and behavior in humans. Combining centrally acting drugs and TMS has proven useful for characterizing the neural basis of movement. This combined intervention approach also holds promise for improving our understanding of the mechanisms underlying disordered behavior associated with psychiatric conditions, including addiction, though challenges exist. For example, altered neocortical function has been implicated in substance use disorder, but the relationship between acute neuromodulation of neocortex with TMS and direct effects on addiction-related behaviors is not well established. We propose that the combination of human behavioral pharmacology methods with TMS can be leveraged to help establish these links. This perspective article describes an ongoing study that combines the administration of delta-9-tetrahydrocannabinol (THC), the main psychoactive compound in cannabis, with neuroimaging-guided TMS in individuals with problematic cannabis use. The study examines the impact of the left dorsolateral prefrontal cortex (DLPFC) stimulation on cognitive outcomes impacted by THC intoxication, including the subjective response to THC and the impairing effects of THC on behavioral performance. A framework for integrating TMS with human behavioral pharmacology methods, along with key details of the study design, are presented. We also discuss challenges, alternatives, and future directions.
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.