A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: Active rTMS; Sham rTMS
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: There is a sham rTMS condition that will allow both participants and investigators to be blinded.
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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 quit cannabis.

          5. Participants must have a Positive UDS for cannabis during their baseline visit
             (confirming they are regular users).

        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 Nicotine Use Disorder.

          3. Participants must not be on any medications that have central nervous system effects.

          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 and
             must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.

          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 90 days.

          8. Participants must not have any contraindications to receiving rTMS (e.g. metal
             implanted above the head, history of seizure, any known brain lesion).

          9. Participants must not have any unstable general medical conditions.