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Trial record 39 of 171 for:    cannabis | Recruiting, Enrolling by invitation Studies

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

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ClinicalTrials.gov Identifier: NCT03144232
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

May 4, 2017
May 8, 2017
May 15, 2018
August 1, 2017
April 1, 2021   (Final data collection date for primary outcome measure)
  • Cue Elicited Craving [ Time Frame: 2 weeks ]
    The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced level of cannabis cue-induced craving following their final rTMS session as compared to prior to their first rTMS session. The investigators will measure self-reported cannabis craving during a validated cannabis cue-reactivity paradigm, and define cue-induced craving as change in self reported craving from pre-to-post cue administration using the marijuana craving questionaire.
  • Cue Reactivity [ Time Frame: 2 weeks ]
    The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced percent signal change in BOLD response in reward structures during a validated cue-reactivity fMRI paradigm following their final TMS session as compared to prior to their first rTMS session.
  • Cue Elicited Craving [ Time Frame: 2 weeks ]
    The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced level of cannabis cue-induced craving following their final rTMS session as compared to prior to their first rTMS session. The investigators will measure self-reported cannabis craving during a validated cannabis cue-reactivity paradigm, and define cue-induced craving as change in self reported craving from pre-to-post cue administration using the marijuana craving questionairre.
  • Cue Reactivity [ Time Frame: 2 weeks ]
    The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced percent signal change in BOLD response in reward structures during a validated cue-reactivity fMRI paradigm following their final TMS session as compared to prior to their first rTMS session.
Complete list of historical versions of study NCT03144232 on ClinicalTrials.gov Archive Site
Abstinence [ Time Frame: 7 weeks ]
The investigators hypothesize that those participants receiving active rTMS will be more likely to be abstinent over the final two-weeks of the study period than those receiving sham rTMS. We will define abstinence as no self reported cannabis use over the final two weeks of the study, and a ratio of four week to two week creatinine corrected urine THCCOOH of < 0.5, suggesting no new use of cannabis.
Same as current
Not Provided
Not Provided
 
A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
There is a sham rTMS condition that will allow both participants and investigators to be blinded.
Primary Purpose: Treatment
Cannabis Use Disorder
  • Device: Active rTMS
    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 (49). Treatment will be delivered at 120% rMT. Each active TMS treatment will consist of a total of 4000 pulses of 10Hz stimulation (5s-on,10s-off). Treatments will be delivered at the EEG coordinate for F3 (which approximates the left DLPFC), and will be found using the Beam-F3 method.
  • Device: Sham rTMS
    Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real TMS. This type of sham has been demonstrated to be indistinguishable from real TMS.
  • Experimental: Active rTMS
    10 Hz rTMS applied to the left DLPFC
    Intervention: Device: Active rTMS
  • Sham Comparator: Sham rTMS
    Sham rTMS applied to the left DLPFC
    Intervention: Device: Sham rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
Same as current
April 1, 2021
April 1, 2021   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Gregory Sahlem, MD 843 792 5215 sahlem@musc.edu
United States
 
 
NCT03144232
Pro00062407
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Medical University of South Carolina
Medical University of South Carolina
Not Provided
Not Provided
Medical University of South Carolina
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP