rTMS as a Tool to Decrease Pain and Opiate Craving Save

Date Added
March 30th, 2016
PRO Number
Pro00042186
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for opiate dependence addiction. Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether rTMS over the prefrontal cortex can produce a reduction in your perception of pain, your desire to use opiates, and your brain?s response to opiate cues. TMS has been approved by the FDA as an investigational tool as well a therapy for depression.

Institution
MUSC
Recruitment Contact
Oliver Mithoefer
843-792-6402
mithoefe@musc.edu

The effects of physical and mental exercises on mood and cognition Save

Date Added
March 9th, 2016
PRO Number
Pro00040050
Researcher
Brett Froeliger
Keywords
Anxiety, Breathing, Depression, Exercise, Healthy Volunteer Studies, Men's Health, Physical Therapy, Psychiatry, Women's Health
Summary

The purpose of this study is to study the effects of Yoga on emotions, thinking, and behavior. Participants will attend 10 weekly, 1.5 hour yoga sessions and 2 experimental visits during the course of the study, as well as fill out questionnaires and perform computerized experimental tasks.

Institution
MUSC
Recruitment Contact
Christie Eichberg
843-882-7196
eichberg@musc.edu

Effect of pregnenolone on cue-reactivity in marijuana-dependent individuals Save

Date Added
March 1st, 2016
PRO Number
Pro00042135
Researcher
Aimee Mc Rae
Keywords
Psychiatry, Substance Use
Summary

Previous studies suggest that pregnenolone may inhibit the intoxicating effects of marijuana and reduce drug-seeking behavior. In this study we are examining the effects of pregnenolone on craving and mood in response to marijuana cues. In addition we are examing the effects of pregnenolone on blood levels of endogenous endocannabinoids.

Institution
MUSC
Recruitment Contact
Lisa Nunn
792-0476
jenkinli@musc.edu

Oxytocin in Cocaine Dependence Save

Date Added
March 1st, 2016
PRO Number
Pro00016890
Researcher
Aimee Mc Rae
Keywords
Drug Studies, Psychiatry, Substance Use
Summary

Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

Multimodal investigation of brain structure and function in Tourette's syndrome Save

Date Added
February 2nd, 2016
PRO Number
Pro00021403
Researcher
Colleen Hanlon
Keywords
Adolescents, Central Nervous System, Healthy Volunteer Studies, Movement Disorders, Nervous System, Pediatrics, Psychiatry
Summary

The purpose of this pilot study is to investigate alterations in neural activity among individuals with Tourettes Syndrome. This will be acheived with single-pulse transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI). These techniques are non-invasive. TMS is a brain stimulation method that allows us to measure the speed of information processing between brain regions as well as between the brain and the muscles. Combine with MRI, these techniques allow us to create a dynamic image of brain activity which may help guide future treatments. It is important to note that this will be used for research purposes and is not diagnostic.

Institution
MUSC
Recruitment Contact
William DeVries
843-792-6402
devriesw@musc.edu

ESKETINTRD3004: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression Save

Date Added
January 26th, 2016
PRO Number
Pro00047444
Researcher
Robert Malcolm
Keywords
Depression, Drug Studies, Mental Health, Psychiatry
Summary

Major depressive disorder is a common, severe, chronic and often life-threatening illness. It is now the leading cause of disability worldwide. There is a clear need to develop novel and improved therapeutics for treatment-resistant major depression.

Studies with esketamine have shown robust antidepressant effects in several clinical studies and it has been well tolerated in these clinical studies.
The main purpose of this study is to assess the long-term safety, tolerability, and effectiveness of esketamine nasal spray plus a newly initiated oral (taken by mouth) antidepressant in patients with treatment-resistant depression.

All patients in this 60 week study will be treated with esketamine nasal spray plus a new oral anti-depressant. The new oral anti-depressant will be one of the following approved and marketed oral antidepressants: duloxetine (Cymbalta), escitalopram (Lexapro), sertraline (Zoloft), or venlafaxine extended release (Effexor XR).

Institution
MUSC
Recruitment Contact
Melissa Michel
843-792-1901
michelm@musc.edu

A Time-Controlled Examination of the Effects of Repeated Measures Design on fMRI Experimental Tasks Save

Date Added
January 19th, 2016
PRO Number
Pro00040073
Researcher
Brett Froeliger
Keywords
Brain, Central Nervous System, Environmental Factors, Nervous System, Psychiatry, Smoking
Summary

The purpose of this study is to examine the effects of experimental design on brain responses.

Institution
MUSC
Recruitment Contact
Christie Eichberg
843-792-3084
eichberg@musc.edu

A Phase 2, Efficacy, Safety, and Tolerability Study of ALKS 3831 in Schizophrenia with Alcohol Use Disorder. Save

Date Added
January 12th, 2016
PRO Number
Pro00039046
Researcher
Mark Hamner
Keywords
Alcohol, Drug Studies, Psychiatry
Summary

This study is designed to evaluate the efficacy, safety, and tolerability of ALKS 3831 in schizophrenia with AUD. ALKS 3831 is a combination of olanzapine, an approved antipsychotic treatment for schizophrenia, and samidorphan, a new medication. Potential subjects for this trial are adults with a diagnosis of schizophrenia and alcohol use disorder (AUD) with a recent change in symptoms. The study will test whether olanzapine with samidorphan will aide in lowering alcohol use for subjects at the same time that the combination of the two drugs lessens side effects of olanzapine such as weight gain.

Institution
MUSC
Recruitment Contact
Deborah Agbor-Tabi
(843)789-7147
agbortab@musc.edu

Development of the Sleep Research Data Repository (SRDR) Save

Date Added
January 11th, 2016
PRO Number
Pro00009339
Researcher
Thomas Uhde
Keywords
Anxiety, Genetics, Mental Health, Psychiatry, Sleep Disorders, Stress Disorders
Summary

The Sleep Research Data Repository (SRDR) aimed to systematically collect, analyze and store for future research sleep and sleep disorders related biological and psychological information. It will include sleep physiological measurements and the results of interviews, questionnaires, and laboratory tests. The SRDR will contain sleep related information obtained from healthy subjects and patients with psychiatric, substance abuse, neurological disorders, or any medical conditions associated with sleep disturbances. SRDR data will be made available to current and future IRB-approved investigators associated with this protocol.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

The Effects of Theta-Burst Stimulation Duration on Human Motor Cortex Excitability Save

Date Added
January 5th, 2016
PRO Number
Pro00051031
Researcher
Colleen Hanlon
Keywords
Psychiatry
Summary

Currently there is an interest in optimizing rTMS protocols and in particular theta burst stimulation as both a therapeutic and investigational research tool. In a recent publication by Gamboa et al. 2010 it was shown that extended theta-burst stimulation duration (80 seconds) might have reverse effects on cortical excitability when compared to the original Huang et al. 2005 publication (40 seconds). While the post treatment effects of the original Huang et al. 2005 protocol were successfully replicated, when cTBS protocols were doubled to 1200 pulses over 80 seconds and the iTBS protocols were doubled to 1200 pulses over 390 seconds, there was increased facilitation after the prolonged cTBS and decreased excitability after prolonged iTBS. In Hanlon et al. 2015 a novel theta burst paradigm (5 minutes) is described in which two trains of 1800 pulses of cTBS, separated by a one-minute interval. This study aims to replicate the findings of the Gamboa and Huang protocols as well as investigate how novel theta burst stimulation paradigms such as those described in Hanlon et al. 2015, which are currently being explored as therapeutic methods in addiction change cortical excitability.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-2335
lenchd@musc.edu

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