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
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Disorder||Device: Active rTMS Device: Sham rTMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|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.|
|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|
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.
- 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.
- 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.
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
|Contact: Gregory Sahlem, MD||843 792 firstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Gregory Sahlem 843-792-5215 email@example.com|