Investigating Two rTMS Strategies to Treat Cannabis Use Disorder

NCT05720312 | Completed Results DMC FDA Device

• 1 other identifier: 68235
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (4)

• Number of Days of Use Per Week.

  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.

  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

  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

  Follow-up period (final week of active treatment plus 6-week post-treatment follow-up)

Study Arms (2)

Dorsolateral Prefrontal Cortex (DLPFC)

EXPERIMENTAL

36 sessions of high frequency (10Hz) rTMS

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Ventromedial Prefrontal Cortex (vmPFC)

EXPERIMENTAL

36 sessions of low frequency (1Hz) rTMS

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

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.

Dorsolateral Prefrontal Cortex (DLPFC); Ventromedial Prefrontal Cortex (vmPFC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Gregory Sahlem, MD
• Organization: Stanford University

gsahlem@stanford.edu

(650) 434-7844

Study Officials

• Gregory Sahlem

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar, Psychiatry

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: July 1, 2023
• Primary Completion: May 14, 2024
• Study Completion: July 1, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)