Cannabis Use DisorderNCT05859347
Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cannabis Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2023to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be deemed to have capacity to provide informed consent
- Age between 18 to 65
- Diagnosis of cannabis use disorder according to the DSM-5 and the Structured Clinical Interview for DSM-5 (SCID for DSM-541)
- Report cannabis as the primary drug of concern, a frequent pattern of use (≥5 days per week), and a goal of reduction or abstinence of cannabis use
- CUDIT-R score ≥12
- Marijuana Contemplation Ladder ≥7
- Cannabis positive urine drug screen, with Narcochek baseline THC-COOH level of >150 ng/ml.
- On a stable regimen of their psychotropic medications for 14 days before enrolment.
Who cannot join
- Pregnant or intending to be pregnant during the study
- Diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other active concurrent psychiatric disorder that is too unstable and may preclude safe participation in the trial as deemed by the PI.
- Substance use disorder other than cannabis or nicotine, that is of moderate severity or greater, or is the primary substance of concern based on the SCID for DSM-5
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Unstable medical illness
- Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
- Participants taking > 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Victor Tang, MD, 416-535-8501, victor.tang@camh.ca
About this study
Official title: Development of a Novel, Scalable, Neurobiologically-Guided Transcranial Magnetic Stimulation Protocol for the Treatment of Cannabis Use Disorder
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.
- Conditions
- Cannabis Use Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Cannabis, Substance Use Disorder, Prefrontal Cortex, Insula, Neuroimaging
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called MagVenture MMC-140 Coil
rTMS is a non-invasive neuromodulatory technique that applies alternating magnetic fields to the scalp to induce electric currents in localized cortical tissue. The intervention (LF or HF rTMS) will be administered daily 5 days/week for 4 weeks, using the MagVenture MMC-140 circular coil, with the brain regions targeted as the bilateral prefrontal cortex and the insula.
| Study group | Role | What they receive |
|---|---|---|
| High-Frequency (HF) | Active comparator | 10 Hz rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Low-Frequency (LF) | Active comparator | 1 Hz rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study completion as assessed by completion rates
Feasibility is determined by completion of the study and all associated study assessments, without withdrawing or being withdrawn from the study. Withdrawal from the study can be dropping out for any reason, including intolerability, serious adverse events, or inability to adhere to study procedures.
Measured: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks, the event determined by withdrawal from the study.
Tolerability of Intervention as assessed by adverse event reporting
This will be assessed through a side effect report at each treatment session. Safety monitoring will be implemented through the documentation and monitoring of adverse events (AEs) and serious adverse events (SAEs) using incidence tables by severity, relationship to treatment and baseline parameters.
Measured: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks. The events being counts of adverse events or serious adverse events.
Secondary outcomes (10)
Cannabis Use
Determined through self-report on the Timeline Followback (TLFB). Endpoints of interest will include percentage of days per week using cannabis, number of use sessions per day, 7-day point prevalence abstinence. Semi-quantitative analysis of cannabis use will be obtained through a THC Pre-Dosage Test (Narcocheck ®, Villejuif, France) to confirm.
Measured: Baseline (pre-rTMS), Weekly (end of each week of rTMS), Follow-up (4-weeks post-rTMS), up to a total time frame of 8 weeks. Events are counted as self reported instances of cannabis use on the Timeline Followback.
Cannabis Craving
Changes in cannabis craving assessed through the Marijuana Craving Questionnaire (MCQ). Minimum score is 3 and maximum score is 84. Higher scores indicate greater cannabis craving (worse outcome).
Measured: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, Follow-up (4-weeks post-rTMS),
Cannabis Withdrawal
Changes in cannabis withdrawal symptoms assessed through the Marijuana Withdrawal Checklist (MWC)
Measured: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, Follow-up (4-weeks post-rTMS),
Prefrontal cortex and Insula Connectivity
Assessed by seed-based resting state connectivity on functional magnetic resonance imaging (fMRI). Seeds are defined as the medial prefrontal cortex, dorsolateral prefrontal cortex, and the insula. Measurement will be of change in strength of connectivity between these seeds pre- to post-rTMS, and comparing between groups (high or low frequency stimulation).
Measured: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS)
Depression symptoms
Changes in depression symptoms assessed through the 17-item Hamilton Rating Scale for Depression (HRSD-17). Minimum score is 0, maximum score is 52, higher scores indicate greater depression (worse outcome)
Measured: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS),
Anxiety symptoms
Changes in anxiety symptoms assessed through the Generalized Anxiety Disorder Scale 7 (GAD-7). Minimum score is 0, maximum score is 21, higher scores indicate greater anxiety (worse outcome).
Measured: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS),
Trail Making Test
Changes on a neuropsychological assessment for attention, speed, and mental flexibility. Part A and Part B. Measurement: number of seconds required to complete the task. • Higher scores reveal greater impairment.
Measured: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Digit Span
Changes on a neuropsychological assessment for working memory. Consists of 2 parts: Forwards and Backwards. Each item is scored 0, 1, or 2 points. (Depending on accuracy). • Lower scores reveal greater impairment. Minimum score 0. Maximum total score on Digit Span: 30 points
Measured: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Hopkins Verbal Learning Test
Changes on a neuropsychological assessment for working memory. Consists of 3 parts: A (free recall), B (delayed recall), C (recognition). Less number of words remembered indicates worse outcome.
Measured: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Continuous Performance Test
Changes on a neuropsychological assessment for sustained attention. Measurement \& Scoring Categories: Correct Detection (number of times the client responded to the target stimulus. Higher rates of correct detections indicate better attentional capacity), reaction times (Amount of time between the presentation of the stimulus and the client's response), omission errors (Number of times the target was presented, but the client did not respond/click the mouse. High omission rates indicate distractibility to stimuli or a sluggish response), commission errors (Number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general).
Measured: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 May 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups to receive either high-frequency (10 Hz) or low-frequency (1 Hz) rTMS.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859347
- Sponsor's protocol ID
- 2022-233
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel, Scalable, Neurobiologically-Guided Transcranial Magnetic Stimulation Protocol for the Treatment of Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT05859347
- Acronym / sponsor ID
- 2022-233
- Conditions
- Cannabis Use Disorder
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Cannabis, Substance Use Disorder, Prefrontal Cortex, Insula, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups to receive either high-frequency (10 Hz) or low-frequency (1 Hz) rTMS.
| Arm | Type | Receives |
|---|---|---|
| High-Frequency (HF) | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation10 Hz rTMS |
| Low-Frequency (LF) | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation1 Hz rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be deemed to have capacity to provide informed consent
- Age between 18 to 65
- Diagnosis of cannabis use disorder according to the DSM-5 and the Structured Clinical Interview for DSM-5 (SCID for DSM-541)
- Report cannabis as the primary drug of concern, a frequent pattern of use (≥5 days per week), and a goal of reduction or abstinence of cannabis use
- CUDIT-R score ≥12
Key exclusion criteria (7 listed)
- Pregnant or intending to be pregnant during the study
- Diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other active concurrent psychiatric disorder that is too unstable and may preclude safe participation in the trial as deemed by the PI.
- Substance use disorder other than cannabis or nicotine, that is of moderate severity or greater, or is the primary substance of concern based on the SCID for DSM-5
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Unstable medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: MagVenture MMC-140 CoilrTMS is a non-invasive neuromodulatory technique that applies alternating magnetic fields to the scalp to induce electric currents in localized cortical tissue. The intervention (LF or HF rTMS) will be administered daily 5 days/week for 4 weeks, using the MagVenture MMC-140 circular coil, with the brain regions targeted as the bilateral prefrontal cortex and the insula. | Device | High-Frequency (HF), Low-Frequency (LF) |
Primary outcome
Feasibility of study completion as assessed by completion rates
Time frame: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks, the event determined by withdrawal from the study.
Feasibility is determined by completion of the study and all associated study assessments, without withdrawing or being withdrawn from the study. Withdrawal from the study can be dropping out for any reason, including intolerability, serious adverse events, or inability to adhere to study procedures.
Tolerability of Intervention as assessed by adverse event reporting
Time frame: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks. The events being counts of adverse events or serious adverse events.
This will be assessed through a side effect report at each treatment session. Safety monitoring will be implemented through the documentation and monitoring of adverse events (AEs) and serious adverse events (SAEs) using incidence tables by severity, relationship to treatment and baseline parameters.
10 secondary outcomes
Cannabis Use
Time frame: Baseline (pre-rTMS), Weekly (end of each week of rTMS), Follow-up (4-weeks post-rTMS), up to a total time frame of 8 weeks. Events are counted as self reported instances of cannabis use on the Timeline Followback.
Cannabis Craving
Time frame: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, Follow-up (4-weeks post-rTMS),
Cannabis Withdrawal
Time frame: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, Follow-up (4-weeks post-rTMS),
Prefrontal cortex and Insula Connectivity
Time frame: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS)
Depression symptoms
Time frame: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS),
Anxiety symptoms
Time frame: Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS),
Trail Making Test
Time frame: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Digit Span
Time frame: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Hopkins Verbal Learning Test
Time frame: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Continuous Performance Test
Time frame: Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cannabis Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Tang, MD ((416) 535-8501, victor.tang@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study completion as assessed by completion rates (time frame: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks, the event determined by withdrawal from the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.