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Investigating Two rTMS Strategies to Treat Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT05720312
Recruitment Status : Recruiting
First Posted : February 9, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Gregory Sahlem, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Preliminary Investigation of Two Repetitive Transcranial Magnetic Stimulation (rTMS) Strategies to Treat Cannabis Use Disorder
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : May 14, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dorsolateral Prefrontal Cortex (DLPFC)
36 sessions of high frequency (10Hz) rTMS
 Device: 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.
Experimental: Ventromedial Prefrontal Cortex (vmPFC)
36 sessions of low frequency (1Hz) rTMS
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Days per week of cannabis use [ Time Frame: 12-weeks ]
    Number of days per week (0-7) where the participant uses any cannabis


Secondary Outcome Measures :
  1. Weeks of abstinence from cannabis [ Time Frame: 12-weeks ]
    Number of weeks where the participant does not use any cannabis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Participants must be between the ages of 18 and 60.
  3. 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.
  4. Participants must express a desire to reduce cannabis use or quit.
  5. Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).
  6. The investigative team must believe each participant is a good study-candidate.

Exclusion Criteria:

  1. Participants must not be pregnant or breastfeeding.
  2. Participants must not meet moderate or severe use disorder of any other substance with the exception of tobacco/nicotine.
  3. Participants must not be on any medications that have central nervous system effects that have changed in the past 4-weeks.
  4. Participants must not have a history of/or current psychotic disorder or bipolar disorder.
  5. Participants must not have any other Axis I condition requiring current treatment.
  6. Participants must not have a history of Dementia or other cognitive impairment.
  7. Participants must not have active suicidal ideation, or a suicide attempt within the past 180 days.
  8. 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).
  9. Participants must not have any unstable general medical conditions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05720312


Contacts
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Contact: Study Team (650) 800-6920 brainstimulationstudy@stanford.edu
Contact: Gregory Sahlem gsahlem@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Study Team    650-374-0907    bwong14@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Gregory Sahlem Stanford University
More Information
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Responsible Party: Gregory Sahlem, Assistant Professor of Psychiatry, Stanford University
ClinicalTrials.gov Identifier: NCT05720312    
Other Study ID Numbers: 68235
First Posted: February 9, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders