Back to resultsInvestigating Two rTMS Strategies to Treat Cannabis Use Disorder
Primary Purpose
Cannabis Use Disorder
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use Disorder
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 6-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. 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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dorsolateral Prefrontal Cortex (DLPFC)
Ventromedial Prefrontal Cortex (vmPFC)
Arm Description
36 sessions of high frequency (10Hz) rTMS
36 sessions of low frequency (1Hz) rTMS
Outcomes
Primary Outcome Measures
Days per week of cannabis use
Number of days per week (0-7) where the participant uses any cannabis
Secondary Outcome Measures
Weeks of abstinence from cannabis
Number of weeks where the participant does not use any cannabis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05720312
Brief Title
Investigating Two rTMS Strategies to Treat Cannabis Use Disorder
Official Title
A Preliminary Investigation of Two Repetitive Transcranial Magnetic Stimulation (rTMS) Strategies to Treat Cannabis Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dorsolateral Prefrontal Cortex (DLPFC)
Arm Type
Experimental
Arm Description
36 sessions of high frequency (10Hz) rTMS
Arm Title
Ventromedial Prefrontal Cortex (vmPFC)
Arm Type
Experimental
Arm Description
36 sessions of low frequency (1Hz) rTMS
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Patterned pulsed magnetic stimulation delivered using an electromagnet. We will use a MagVenture rTMS device and a Cool-B65 coil.
Primary Outcome Measure Information:
Title
Days per week of cannabis use
Description
Number of days per week (0-7) where the participant uses any cannabis
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Weeks of abstinence from cannabis
Description
Number of weeks where the participant does not use any cannabis
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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 6-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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Team
Phone
(650) 800-6920
Email
brainstimulationstudy@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Sahlem
Email
gsahlem@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sahlem
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Team
Phone
650-374-0907
Email
bwong14@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating Two rTMS Strategies to Treat Cannabis Use Disorder
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