A Preliminary Investigation of Pre-Frontal repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder. Save

Date Added
January 3rd, 2017
PRO Number
Pro00062407
Researcher
Gregory Sahlem
Keywords
Mental Health, Psychiatry
Summary

Recent research suggests that a new kind of treatment repetitive transcranial magnetic stimulation (rTMS) can help people with addictions quit. This study seeks to recruit individuals who are currently heavy cannabis users, who are attempting to quit using cannabis. In addition to having a 50% chance of receiving rTMS, participants will be given a behavioral treatment with known efficacy.

Institution
MUSC
Recruitment Contact
Margaret Caruso
843-792-5215
warnerma@musc.edu

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression and Adult Female Subjects with Moderate Postpartum Depression. Save

Date Added
December 13th, 2016
PRO Number
Pro00061434
Researcher
Constance Guille
Keywords
Depression, Drug Studies, Mental Health, Post Partum Depression, Psychiatry, Women's Health
Summary

This a study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects diagnosed with severe and moderate postpartum depression(PPD). The study will consist of an up to 5-day Screening Period, 3-day Treatment Period, and 30-day Follow-up Period. Subjects must remain as inpatient during the study Treatment Period, which is approximately 60 hours in duration. Assessments and laboratory samples will be collected during the Treatment Period and the Follow-up Period.

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

Developing brain stimulation as a treatment for pain in opiate dependent individuals: Parametric assessment of 2 evidence-based strategies Save

Date Added
December 6th, 2016
PRO Number
Pro00061328
Researcher
Colleen Hanlon
Keywords
Psychiatry
Summary

PROJECT SUMMARY 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. To parametrically evaluate these two promising treatment strategies, we have developed a three-visit crossover design wherein a cohort of buprenorphine-maintained (as a therapeutic technique to address opiate dependence) opiate dependent individuals will receive interleaved TMS/BOLD imaging and our established MRI-based thermal pain paradigm immediately before and after rTMS. We 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.

Institution
MUSC
Recruitment Contact
Sarah Hamilton
843-792-6402
hamilsar@musc.edu

Developing an integrated exposure-based therapy for co-occurring PTSD and substance use among adolescents: Teen COPE focus groups Save

Date Added
December 6th, 2016
PRO Number
Pro00060455
Researcher
Sudie Back
Keywords
Adolescents, Alcohol, Anxiety, Mental Health, Psychiatry, Substance Use
Summary

This study aims to conduct focus groups with adolescents and parents (30 adolescents and 30 parents) to gather feedback to help design an integrated psychological therapy for co-occurring PTSD and substance use among adolescents (Teen COPE). This information will be used to make revisions to the new Teen COPE Therapist Guide and Patient Workbook.

Institution
MUSC
Recruitment Contact
Emma Barrett
843-792-5594
barrette@musc.edu

Neuroscience-Informed Treatment Development for Adolescent Alcohol Use Save

Date Added
October 4th, 2016
PRO Number
Pro00058771
Researcher
Lindsay Squeglia
Keywords
Adolescents, Alcohol, Brain, Drug Studies, Healthy Volunteer Studies, Pediatrics, Psychiatry, Substance Use
Summary

This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement on brains of youth (ages 15-19) using magnetic resonance imaging (MRI). 50 adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days. Urine and blood samples will be collected at baseline and urine samples again before and after each course of medication treatment. Participants will receive a 1- hour MRI scan at baseline and after each treatment trial.

You/your child could be eligible to participate if he or she is:
Between the ages of 15 and 19.
Has consumed alcohol.
Participants must provide informed consent and youth under 18 must have parental consent to participate.
Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Lindsay Meredith
(843) 792-1017
meredith@musc.edu

Measuring Consciousness From Theory to Practice: Nuts and Bolts Save

Date Added
June 7th, 2016
PRO Number
Pro00054195
Researcher
Mark George
Keywords
Brain, Psychiatry
Summary

We will study healthy adults with a brain stimulation tool (TMS) either inside or outside of the MRI scanner, and test with EEG whether it matters where we place the TMS coil on the head. The TMS induced changes in EEG have been proposed as a surrogate measure of brain connectedness, which changes greatly when we are conscious and when we are not.

Institution
MUSC
Recruitment Contact
Sarah Hamilton
843-876-5141
hamilsar@musc.edu

Personalized Smoking Relapse Prevention Delivered in Real-Time via Just-in-Time-Adaptive Interventions Save

Date Added
May 3rd, 2016
PRO Number
Pro00054686
Researcher
Bryan Heckman
Keywords
Asthma, Breathing, Heart, Hypertension/ High Blood Pressure, Lung, Mental Health, Psychiatry, Shortness of Breath, Smoking, Substance Use
Summary

The study involves use of a new quit-smoking smartphone application. Participants will use the app for two days, which involves completing surveys several times a day (approx. 15 min each) and logging any smoking activity. Participants do not need to make a quit-attempt. Participants will have the opportunity to make suggestions that may improve the development of the app.

Institution
MUSC
Recruitment Contact
Cullen McWhite
(843) 792-2479
mcwhite@musc.edu

Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression Save

Date Added
May 3rd, 2016
PRO Number
Pro00054689
Researcher
Julianne Hellmuth
Keywords
Alcohol, Drug Studies, Healthy Volunteer Studies, Mental Health, Psychiatry
Summary

Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin?s effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-792-2522
beylott@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

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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