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Trial record 39 of 149 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Device: Active rTMS Device: Sham rTMS Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
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
Official Title: A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Active rTMS
10 Hz rTMS applied to the left DLPFC
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.

Sham Comparator: Sham rTMS
Sham rTMS applied to the left DLPFC
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144232


Contacts
Contact: Gregory Sahlem, MD 843 792 5215 sahlem@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Gregory Sahlem    843-792-5215    sahlem@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03144232     History of Changes
Other Study ID Numbers: Pro00062407
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders