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Clinical Trial Summary

The purpose of this study is to parametically evaluate two different types of repetitive Transcranial Magnetic Stimulation (rTMS) treatment strategies as a potential treatment for pain in individuals currently taking prescription opiates. Repetitive TMS is a non-invasive tool that uses magnetic pulses to temporarily stimulate specific brain areas. This study will test whether rTMS over different locations of the prefrontal cortex can produce a reduction in an individuals perception of pain and how the brain responds to pain. Participants will be randomized to receive either sham-rTMS, or one of two real rTMS treatments. Brain imaging, behavioral assessments, and pain assessments will be collected both immediately before and after rTMS.

Clinical Trial Description

Chronic use of opiates is a rapidly escalating crisis in the United States, with over 4.3 million Americans dependent on opiate analgesic, an escalating rate of opiate overdose deaths, and a resurgence of intravenous heroin use leading to total societal cost exceeding $55 billion. The struggle to break the addiction cycle is likely due to factors that affect neural circuits that govern craving and cognitive control. There is growing interest in the utilization of prefrontal cortex repetitive transcranial magnetic stimulation (rTMS) as a novel, non-invasive, non-pharmacologic approach to decreasing craving among chronic opiate users. At this early stage of development, however, it is unclear if the best TMS strategy is to (Strategy 1, Aim 1) increase activity in the dorsolateral prefrontal cortex, or (Strategy 2, Aim 2) decrease activity in the ventromedial prefrontal cortex.

DESIGN: To parametrically evaluate these two promising treatment strategies, the investigators have developed a design where opiate dependent individuals and healthy controls will be randomized to receive either one placebo-like TMS treatment, or one of two real TMS treatments (DLPFC iTBS or MPFC cTBS). Participants with opiate dependence will be recruited from the local community, as well as the MUSC Center for Drug and Alcohol Programs (CDAP), the Ralph H. Johnson Substance Abuse Treatment Center and local pain clinics. Healthy controls will be recruited from the local community. Approved Study Team Members will visit the above mentioned clinics and community and talk with patients. Individuals who consent will receive interleaved TMS/BOLD imaging and our established MRI-based thermal pain paradigm immediately before and after rTMS. The investigators will also measure subjective pain and opiate craving ratings. The relative efficacy of Strategy 1 vs 2 will directly translate to development of a large clinical trial of rTMS as an innovative, new treatment option for pain in opiate dependent individuals. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03576781
Study type Interventional
Source Medical University of South Carolina
Contact Colleen A Hanlon, PhD
Phone 843-792-5732
Status Recruiting
Phase Early Phase 1
Start date February 9, 2017
Completion date December 2019

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