Cannabis Use DisorderNCT05720312
Investigating Two rTMS Strategies to Treat Cannabis Use Disorder
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cannabis Use Disorder, run by Stanford University at 1 site in United States.
Trial summary
In this trial we will work with a group of participants who are having problems related to marijuana use (they have Cannabis Use Disorder) and who want to reduce the amount of marijuana they use or quit using marijuana completely. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be between the ages of 18 and 60.
- Participants must meet DSM-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 out of the last 28 days.
- Participants must express a desire to reduce cannabis use or quit.
- Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).
- The investigative team must believe each participant is a good study-candidate.
Who cannot join
- Participants must not be pregnant or breastfeeding.
- Participants must not meet moderate or severe use disorder of any other substance with the exception of tobacco/nicotine.
- Participants must not be on any medications that have central nervous system effects that have changed in the past 4-weeks.
- Participants must not have a history of/or current psychotic disorder or bipolar disorder.
- Participants must not have any other Axis I condition requiring current treatment.
- Participants must not have a history of Dementia or other cognitive impairment.
Show all 9Show fewer
- Participants must not have active suicidal ideation, or a suicide attempt within the past 180 days.
- Participants must not have any contraindications to receiving rTMS or MRI (e.g. metal implanted above the head, history of seizure, any known brain lesion).
- Participants must not have any unstable general medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Investigation of Two Repetitive Transcranial Magnetic Stimulation (rTMS) Strategies to Treat Cannabis Use Disorder
In this trial we will work with a group of participants who are having problems related to marijuana use (they have Cannabis Use Disorder) and who want to reduce the amount of marijuana they use or quit using marijuana completely. We are testing to see if a treatment called repetitive transcranial magnetic stimulation (rTMS) can help them achieve that goal when combined with a brief three-session counseling therapy. Participants will receive rTMS to one of two different parts of the brain (the dorsolateral prefrontal cortex--the DLPFC or the ventromedial prefrontal cortex--the vmPFC) to see if applying rTMS to one brain area is more helpful than the other brain area.
Read the detailed description
In this preliminary trial, we will test whether applying repetitive transcranial magnetic stimulation (rTMS) to one of two brain areas will help participants with Cannabis Use Disorder reduce the amount of cannabis they use or quit using cannabis completely. To do so, we will recruit participants from the community (or addictions medicine treatment centers) who meet the criteria for Cannabis Use Disorder (heavy use of cannabis causing social, occupational, or health problems) and want to either substantially reduce the amount of cannabis they use or quit using cannabis entirely. Participants will be randomized (in a 1:1 allocation) to receive rTMS to either the left dorsolateral prefrontal cortex (DLPFC) or the ventromedial prefrontal cortex (vmPFC). All participants will also receive evidence-based counseling to help them reduce the amount of cannabis they use. We will deliver study treatment with rTMS to participants over 18-study-visits occurring either two or three times each week and then will see whether the study treatment has helped by meeting with participants four times over six weeks. We will also see how the rTMS effected brain function by having participants undergo two scans using magnetic resonance imaging (MRI).
- Conditions
- Cannabis Use Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Patterned pulsed magnetic stimulation delivered using an electromagnet. We will use a MagVenture rTMS device and a Cool-B65 coil.
| Study group | Role | What they receive |
|---|---|---|
| Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | 36 sessions of high frequency (10Hz) rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Ventromedial Prefrontal Cortex (vmPFC) | Experimental | 36 sessions of low frequency (1Hz) rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of Participants Who Started and Completed Treatment
Measured: 6 to 9 weeks
Number (%) of Participants Who Had Successful Generation of Functional Magnetic Resonance Imaging (fMRI) Targets
Measured: Day 1 (90 minutes to complete scan)
Number (%) Weeks of Abstinence From Cannabis
Number (%) of weeks where the participant does not use any cannabis.
Measured: 13 weeks (final 7 weeks of active treatment plus 6-week post-treatment follow-up)
Secondary outcomes (4)
Number of Days of Use Per Week.
Number of days per week (0-7) where the participant uses any cannabis. At the time of enrollment participants were asked to recall the number of days of cannabis use per week for the 4 weeks prior to enrollment. Participants were then asked (over a period of 7 weeks) to recall days of use at the last fMRI visit (during prior week) and at the week 2, 4, and 6 follow-up visits. Average values are reported for the 4-week period prior to enrollment and the 7-week period at end of treatment at follow-up.
Measured: 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-up
Average Number of Use Sessions Per Week.
Number of use sessions per week where the participant uses any cannabis. At the time of enrollment participants were asked to recall the number of cannabis use sessions per week for the 4 weeks prior to enrollment. Participants were then asked (over a period of 7 weeks) to recall the number of cannabis use sessions at the last fMRI visit (during prior week) and at the week 2, 4, and 6 follow-up visits. Average values are reported for the 4-week period prior to enrollment and the 7-week period at end of treatment at follow-up.
Measured: 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-up
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Scale Score
The Q-LES-Q-SF overall score range is from 14 to 70, with higher scores indicating greater satisfaction and enjoyment. The total score is expressed as a percentage of the maximum possible score (1-100).
Measured: Baseline and end of the follow-up period (12 to 15 weeks post-baseline)
Number of Participants Who Had a Period of 4-consecutive Weeks of Abstinence During the Follow-up Period
Based on patient self-report of any 4-week period of abstinence
Measured: Follow-up period (final week of active treatment plus 6-week post-treatment follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jul 2023
- Primary completion14 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel McCalley, Stanford University
- Investigators
- Gregory Sahlem, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720312
- Sponsor's protocol ID
- 68235
- Status last verified
- May 2025
- First submitted
- 31 Jan 2023
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Investigation of Two Repetitive Transcranial Magnetic Stimulation (rTMS) Strategies to Treat Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT05720312
- Acronym / sponsor ID
- 68235
- Conditions
- Cannabis Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this trial we will work with a group of participants who are having problems related to marijuana use (they have Cannabis Use Disorder) and who want to reduce the amount of marijuana they use or quit using marijuana completely. We are testing to see if a treatment called repetitive transcranial magnetic stimulation (rTMS) can help them achieve that goal when combined with a brief three-session counseling therapy. Participants will receive rTMS to one of two different parts of the brain (the dorsolateral prefrontal cortex--the DLPFC or the ventromedial prefrontal cortex--the vmPFC) to see if applying rTMS to one brain area is more helpful than the other brain area.
Detailed description
In this preliminary trial, we will test whether applying repetitive transcranial magnetic stimulation (rTMS) to one of two brain areas will help participants with Cannabis Use Disorder reduce the amount of cannabis they use or quit using cannabis completely. To do so, we will recruit participants from the community (or addictions medicine treatment centers) who meet the criteria for Cannabis Use Disorder (heavy use of cannabis causing social, occupational, or health problems) and want to either substantially reduce the amount of cannabis they use or quit using cannabis entirely. Participants will be randomized (in a 1:1 allocation) to receive rTMS to either the left dorsolateral prefrontal cortex (DLPFC) or the ventromedial prefrontal cortex (vmPFC). All participants will also receive evidence-based counseling to help them reduce the amount of cannabis they use. We will deliver study treatment with rTMS to participants over 18-study-visits occurring either two or three times each week and then will see whether the study treatment has helped by meeting with participants four times over six weeks. We will also see how the rTMS effected brain function by having participants undergo two scans using magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)36 sessions of high frequency (10Hz) rTMS |
| Ventromedial Prefrontal Cortex (vmPFC) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)36 sessions of low frequency (1Hz) rTMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be between the ages of 18 and 60.
- Participants must meet DSM-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 out of the last 28 days.
- Participants must express a desire to reduce cannabis use or quit.
- Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).
Key exclusion criteria (9 listed)
- Participants must not be pregnant or breastfeeding.
- Participants must not meet moderate or severe use disorder of any other substance with the exception of tobacco/nicotine.
- Participants must not be on any medications that have central nervous system effects that have changed in the past 4-weeks.
- Participants must not have a history of/or current psychotic disorder or bipolar disorder.
- Participants must not have any other Axis I condition requiring current treatment.
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 Stimulation (rTMS)Patterned pulsed magnetic stimulation delivered using an electromagnet. We will use a MagVenture rTMS device and a Cool-B65 coil. | Device | Dorsolateral Prefrontal Cortex (DLPFC), Ventromedial Prefrontal Cortex (vmPFC) |
Primary outcome
Number (%) of Participants Who Started and Completed Treatment
Time frame: 6 to 9 weeks
Number (%) of Participants Who Had Successful Generation of Functional Magnetic Resonance Imaging (fMRI) Targets
Time frame: Day 1 (90 minutes to complete scan)
Number (%) Weeks of Abstinence From Cannabis
Time frame: 13 weeks (final 7 weeks of active treatment plus 6-week post-treatment follow-up)
Number (%) of weeks where the participant does not use any cannabis.
4 secondary outcomes
Number of Days of Use Per Week.
Time frame: 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-up
Average Number of Use Sessions Per Week.
Time frame: 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-up
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Scale Score
Time frame: Baseline and end of the follow-up period (12 to 15 weeks post-baseline)
Number of Participants Who Had a Period of 4-consecutive Weeks of Abstinence During the Follow-up Period
Time frame: Follow-up period (final week of active treatment plus 6-week post-treatment follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cannabis Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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. This study is not recruiting at the moment.
Gregory Sahlem principal investigator
Stanford University
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 (rTMS) in people with Cannabis Use Disorder, run by Stanford University at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 28 May 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (%) of Participants Who Started and Completed Treatment (time frame: 6 to 9 weeks). The study lists 3 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 28 May 2025.