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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Cannabis Use Disorder

Treatments: Device: Sham rTMS; Device: Active rTMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03144232

K23DA043628 (U.S. NIH Grant/Contract)

56294

Details and patient eligibility

About

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.

Full description

The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS results in reduced cannabis behavioral craving in treatment-seeking individuals with CUD (Aim1). Additionally, the investigators seek to explore the mechanistic underpinnings of any observed effect, by collecting functional magnetic resonance imaging data during cannabis cue administration before and after the treatment course (Aim 2). These aims will be addressed through a nine-week, double-blind, randomized, sham-controlled study in which 72 treatment-seeking cannabis use disordered participants (36/group) will be given 20 sessions of either Active or Sham excitatory rTMS applied to the DLPFC. rTMS will be delivered over five weeks (2 sessions each day, two days each week). rTMS will be applied in conjunction with a validated three-session Motivational Enhancement Therapy (MET) behavioral intervention.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

Active rTMS

Experimental group

Description:

10 Hz rTMS applied to the left DLPFC

Treatment:

Device: Active rTMS

Sham rTMS

Sham Comparator group

Description:

Sham rTMS applied to the left DLPFC

Treatment:

Device: Sham rTMS