An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) and Sham Repetitive Transcranial Magnetic Stimulation in Cannabis, sponsored by Medical University of South Carolina. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-02.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Basic science
This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.
Our primary aims are to determine the effect of a single session of 10 Hz L DLPFC rTMS on cannabis cue induced craving (Aim1), and behavioral tasks of impulsive decision making (Aim2), in non-treatment seeking individuals with Cannabis Use Disorder. The aims of the study will be accomplished by performing a double-blind, sham-controlled crossover trial. Non-Treatment seeking individuals with CUD will be recruited through media advertisements, as well as via a pre-established database of non-treatment seeking individuals who have participated in previous Cannabis trials and agreed to be re-contacted. Interested individuals will undergo a brief phone screen to determine if they meet general inclusion/exclusion criteria, and if so will be invited to meet with study personnel in order to sign informed consent, and undergo a screening visit. There will then be two experimental visits separated by at least one week. During each of these visits participants will undergo either a real, or sham rTMS treatment, as well as a cannabis cue Paradigm. Data on craving as well as on impulsive decision making will be collected before and after each treatment.
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS will be delivered to the Left DLPFC at 10 Hz using an electronic sham system used in multiple other investigations. A total of 4000 pulses of sham rTMS will be delivered.
Device: Sham Repetitive Transcranial Magnetic Stimulation
rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
rTMS will be delivered via an electronic sham coil that mimics real rTMS in appearance, sound, and feeling. Pulses will be delivered to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
Marijuana Craving Questionnaire (MCQ)
The MCQ will be given before and after a marijuana-cue paradigm, and the primary outcome will be the change score from pre to post.
Time frame: 15 Minutes
The Balloon Aptitude Response Task (BART)
The BART will be given pre, and post rTMS. Number of corrected pumps, and number of burst balloons will be collected.
Time frame: 30 Minutes
No study locations are listed for this record.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina