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

NCT03144232 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: 56294K23DA043628
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (2)

• Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving

  The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced level of behavioral cannabis craving prior to their final rTMS session as compared to prior to their first rTMS session. The investigators will measure behavioral cannabis craving using the marijuana craving questionnaire. Score range: 12 to 84, higher scores represent more craving.

  Baseline (pre) and Week-5 (post)

• Cue Reactivity

  The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced BOLD response in reward structures (dorsal striatum, ventral striatum, and anterior consulate cortex) during a validated cue-reactivity fMRI paradigm prior to their final rTMS session as compared to prior to their first rTMS session (change score). The following beta scores represent the change score (post-pre) in scans in the drug stimuli minus neutral stimuli subtraction map. Generally, more activation (a positive score) represents more cannabis image cue-reactivity, and the reported range represents standard units as output in the fMRI.

  Baseline (pre) and Week-5 (post)

Secondary Outcomes (1)

• Abstinence

  4-weeks

Study Arms (2)

Active rTMS

EXPERIMENTAL

10 Hz rTMS applied to the left DLPFC

Device: Active rTMS

Sham rTMS

SHAM COMPARATOR

Sham rTMS applied to the left DLPFC

Device: Sham rTMS

Interventions

Active rTMS DEVICE

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.

Active rTMS

Sham rTMS DEVICE

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.

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Results Point of Contact

• Title: Gregory Sahlem
• Organization: Stanford University

gsahlem@stanford.edu

650-724-0444

Study Officials

• Gregory Sahlem, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There is a sham rTMS condition that will allow both participants and investigators to be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: August 1, 2017
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 9, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)