Phase 2 N=72 Randomized Quadruple-blind Treatment

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

Cannabis Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03144232 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving — 45.8; 45.2; 27.7; 22.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Active rTMS (Device); Sham rTMS (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving	45.8; 45.2; 27.7; 22.6	—
PRIMARY Cue Reactivity	0.010; -0.025; -0.013; -0.022; 0.003; -0.015	—
SECONDARY Abstinence	.62; .37	—

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

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 quit cannabis.
Participants must have a Positive UDS for cannabis during their baseline visit (confirming they are regular users).

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 Nicotine Use Disorder.
Participants must not be on any medications that have central nervous system effects.
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 and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.
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 90 days.
Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion).
Participants must not have any unstable general medical conditions.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03144232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.