CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Active rTMS +1 moredevice
Likely dose
120% of resting motor threshold (rMT)AI-extracted
Key inclusion· 5
  • Age 18-60 years
  • Meet DSM-5 criteria for at least moderate Cannabis Use Disorder with use on ≥20 of the last 28 days
  • Positive urine drug screen for cannabis at baseline visit
  • Express desire to quit cannabis
Key exclusion· 9
  • Pregnant or breastfeeding
  • Moderate or severe use disorder of any substance except nicotine
  • CNS-active medications
  • History of or current psychotic disorder or bipolar disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03144232
NCT03144232Phase 2Completed

A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder

Stanford University·interventional·Posted May 8, 2017·Updated Aug 9, 2023

In Brief

A Phase 2 clinical trial evaluating Active rTMS and Sham rTMS for Cannabis Use Disorder. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 8, 2017
Enrollment StartAug 1, 2017
Primary CompletionJul 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.2 years ago

Interventions

Active rTMSdevice

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 rTMSdevice

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.