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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | 36 sessions of high frequency (10Hz) rTMS |
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| Ventromedial Prefrontal Cortex (vmPFC) | Experimental | 36 sessions of low frequency (1Hz) rTMS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of Participants Who Started and Completed Treatment | 6 to 9 weeks | |
| Number (%) of Participants Who Had Successful Generation of Functional Magnetic Resonance Imaging (fMRI) Targets | Day 1 (90 minutes to complete scan) | |
| Number (%) Weeks of Abstinence From Cannabis | Number (%) of weeks where the participant does not use any cannabis. | 13 weeks (final 7 weeks of active treatment plus 6-week post-treatment follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Sahlem | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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22 participants signed informed consent, and 20 were randomized to treatment.
Participants receive 6 to 9 weeks of active treatment, then enter a 7 week follow-up period, from the last treatment (up to 1 week) plus 6 weeks post-treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dorsolateral Prefrontal Cortex (DLPFC) | 36 sessions of high frequency (10Hz) repetitive Transcranial Magnetic Stimulation (rTMS). |
| FG001 | Ventromedial Prefrontal Cortex (vmPFC) | 36 sessions of low frequency (1Hz) rTMS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period (6 to 9 Weeks) |
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| Follow-up Period (6 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dorsolateral Prefrontal Cortex (DLPFC) | 36 sessions of high frequency (10Hz) rTMS. |
| BG001 | Ventromedial Prefrontal Cortex (vmPFC) | 36 sessions of low frequency (1Hz) rTMS. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number (%) of Participants Who Started and Completed Treatment | Posted | Count of Participants | Participants | 6 to 9 weeks |
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Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DLPFC - Treatment Period | 36 sessions of high frequency (10Hz) rTMS. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Sahlem, MD | Stanford University | (650) 434-7844 | gsahlem@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2023 | May 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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. | 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). | 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 | Follow-up period (final week of active treatment plus 6-week post-treatment follow-up) |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Number (%) of Participants Who Had Successful Generation of Functional Magnetic Resonance Imaging (fMRI) Targets | Posted | Count of Participants | Participants | Day 1 (90 minutes to complete scan) |
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| Primary | Number (%) Weeks of Abstinence From Cannabis | Number (%) of weeks where the participant does not use any cannabis. | Posted | Count of Units | patient weeks | 13 weeks (final 7 weeks of active treatment plus 6-week post-treatment follow-up) | patient weeks | patient weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | days per week | 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-up |
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| Secondary | 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. | Posted | Mean | Standard Deviation | use sessions per week | 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-up |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of the follow-up period (12 to 15 weeks post-baseline) |
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| Secondary | 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 | Posted | Count of Participants | Participants | Follow-up period (final week of active treatment plus 6-week post-treatment follow-up) |
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| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | vmPFC - Treatment Period | 36 sessions of low frequency (1Hz) rTMS. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | DLPFC - Follow-up Period | 36 sessions of high frequency (10Hz) rTMS. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | vmPFC - Follow-up Period | 36 sessions of low frequency (1Hz) rTMS. | 0 | 8 | 0 | 8 | 0 | 8 |
| Headache | Nervous system disorders | Systematic Assessment |
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| Transient Vision Change | Eye disorders | Systematic Assessment |
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