Palo Alto, California 94304

  • Cannabis Use Disorder

Purpose:

This investigation will preliminarily determine if a course of high frequency rTMS applied to the left dorsolateral prefrontal cortex, will reduce cue elicited craving, and cue reactivity in treatment seeking cannabis use disordered participants.


Study summary:

The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS results in reduced cannabis cue-induced 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 seven 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. TMS will be delivered in an accelerated fashion over two weeks (2 sessions each day, five days each week). TMS will be applied in conjunction with a validated two-session Motivational Enhancement Therapy (MET) behavioral intervention.


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 enrollment visit (confirming they are regular users). Exclusion Criteria: 1. Participants must not be pregnant or breastfeeding. 2. Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit. 3. Participants must not meet moderate or severe use disorder of any other substance with the exception of Nicotine Use Disorder. 4. Participants must not be on any medications that have central nervous system effects. 5. Participants must not have a history of/or current psychotic disorder or bipolar disorder. 6. Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms. 7. Participants must not have a history of Dementia or other cognitive impairment. 8. Participants must not have active suicidal ideation, or a suicide attempt within the past 90 days. 9. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion). 10. Participants must not have any unstable general medical conditions.


NCT ID:

NCT03144232


Primary Contact:

Principal Investigator
Gregory Sahlem, MD
Stanford University

Study Team
Phone: (650) 800-6920
Email: brainstimulationstudy@stanford.edu


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Study Team
Phone: 650-397-3933
Email: sadinew@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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