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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA043628 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This investigation will preliminarily determine if a course of high-frequency rTMS applied to the left dorsolateral prefrontal cortex, will reduce behavioral craving, and fMRI cue-reactivity in treatment-seeking cannabis use disordered participants.
The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS results in reduced cannabis behavioral craving in treatment-seeking individuals with CUD (Aim1). Additionally, the investigators seek to explore the mechanistic underpinnings of any observed effect, by collecting functional magnetic resonance imaging data during cannabis cue administration before and after the treatment course (Aim 2). These aims will be addressed through a nine-week, double-blind, randomized, sham-controlled study in which 72 treatment-seeking cannabis use disordered participants (36/group) will be given 20 sessions of either Active or Sham excitatory rTMS applied to the DLPFC. rTMS will be delivered over five weeks (2 sessions each day, two days each week). rTMS will be applied in conjunction with a validated three-session Motivational Enhancement Therapy (MET) behavioral intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | 10 Hz rTMS applied to the left DLPFC |
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| Sham rTMS | Sham Comparator | Sham rTMS applied to the left DLPFC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS | Device | rTMS will be delivered via a MagPro double blinded rTMS Research System (MagVenture, Denmark) with a Cool-B65 Butterfly Coil (a combined active and sham coil). We will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Study-treatment will be delivered at 120% rMT. Each active rTMS study-treatment will consist of a total of 4000 pulses of 10Hz stimulation (5s-on,10s-off). Study-treatments will be delivered at the EEG coordinate for F3 (which approximates the left DLPFC), and will be found using the Beam-F3 method. |
| Measure | Description | Time Frame |
|---|---|---|
| Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving | The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced level of behavioral cannabis craving prior to their final rTMS session as compared to prior to their first rTMS session. The investigators will measure behavioral cannabis craving using the marijuana craving questionnaire. Score range: 12 to 84, higher scores represent more craving. | Baseline (pre) and Week-5 (post) |
| Cue Reactivity | The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced BOLD response in reward structures (dorsal striatum, ventral striatum, and anterior consulate cortex) during a validated cue-reactivity fMRI paradigm prior to their final rTMS session as compared to prior to their first rTMS session (change score). The following beta scores represent the change score (post-pre) in scans in the drug stimuli minus neutral stimuli subtraction map. Generally, more activation (a positive score) represents more cannabis image cue-reactivity, and the reported range represents standard units as output in the fMRI. | Baseline (pre) and Week-5 (post) |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | Number of weeks (out of a total of 4 possible), in the follow-up period, where participants were abstinent from cannabis. Missing data was conservatively assumed to be non-abstinant. More weeks of abstinence is more favourable | 4-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Sahlem, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Repetitive Transcranial Magnetic Stimulation (rTMS) | 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC). |
| FG001 | Sham rTMS | Sham rTMS applied to the left DLPFC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Repetitive Transcranial Magnetic Stimulation (rTMS) | 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC). |
| BG001 | Sham rTMS | Sham rTMS applied to the left DLPFC. |
| 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 | Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving | The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced level of behavioral cannabis craving prior to their final rTMS session as compared to prior to their first rTMS session. The investigators will measure behavioral cannabis craving using the marijuana craving questionnaire. Score range: 12 to 84, higher scores represent more craving. | All participants were included in the analysis using a mixed model, but the post-treatment mean and standard deviation only included available data (participants who completed treatment). | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre) and Week-5 (post) |
|
9-weeks
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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 | Repetitive Transcranial Magnetic Stimulation (rTMS) | 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Sahlem | Stanford University | 650-724-0444 | 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: Amendment 1.2 | Aug 31, 2021 | Jul 7, 2023 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Final Statistical Analysis Plan | Jun 27, 2023 | Jul 7, 2023 | SAP_001.pdf |
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There is a sham rTMS condition that will allow both participants and investigators to be blinded.
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| Sham rTMS | Device | Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of rTMS, combined with a TENS device which produces a small electric shock mimicking the feeling of active rTMS. This type of sham has been demonstrated to be indistinguishable from active rTMS. |
|
| 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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| OG001 | Sham rTMS | Sham rTMS applied to the left DLPFC. |
|
|
| Primary | Cue Reactivity | The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced BOLD response in reward structures (dorsal striatum, ventral striatum, and anterior consulate cortex) during a validated cue-reactivity fMRI paradigm prior to their final rTMS session as compared to prior to their first rTMS session (change score). The following beta scores represent the change score (post-pre) in scans in the drug stimuli minus neutral stimuli subtraction map. Generally, more activation (a positive score) represents more cannabis image cue-reactivity, and the reported range represents standard units as output in the fMRI. | Participants with data at both pre and post time-points were included in the analysis. | Posted | Mean | Standard Deviation | BOLD signal change | Baseline (pre) and Week-5 (post) |
|
|
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| Secondary | Abstinence | Number of weeks (out of a total of 4 possible), in the follow-up period, where participants were abstinent from cannabis. Missing data was conservatively assumed to be non-abstinant. More weeks of abstinence is more favourable | Posted | Mean | Standard Deviation | weeks | 4-weeks |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 16 |
| 37 |
| EG001 | Sham rTMS | Sham rTMS applied to the left DLPFC. | 0 | 35 | 0 | 35 | 7 | 35 |
| Fatigue | Nervous system disorders | Systematic Assessment |
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| Eye twitch | Eye disorders | Systematic Assessment |
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| Jaw Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Site discomfort | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Mood Swings | Psychiatric disorders | Systematic Assessment |
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| Hand numbness | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Anterior Cingulate Cortex |
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