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

Tobacco smoking is the leading cause of preventable death worldwide, and the need for new and improved treatment approaches is further highlighted by the fact that only 5% of smokers who make a quit attempt can maintain abstinence for at least one year. In an effort to reduce relapse risk the proposed study will develop a personalized intervention that will deliver evidence-based treatment in real-time through mobile phones to meet the dynamic needs of patients engaged in a quit attempt. Given the high rates of mobile phone ownership, this intervention has great promise for increasing access to smoking cessation/relapse prevention services, thereby benefiting public health.

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

10 days of medial prefrontal cortex theta burst stimulation (MPFC cTBS) as a tool to improve clinical outcomes and decrease frontal-striatal reactivity to cues among treatment-engaged cocaine users Save

Date Added
October 6th, 2015
PRO Number
Pro00046438
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Substance Use
Summary

The goal of this pilot study is to determine if, in treatment-seeking substance dependent individuals, ten sessions of continuous theta burst transcranial magnetic brain stimulation (cTBS) over a brain region involved in craving (medial prefrontal cortex) can lower an individual's craving and brain response to drug-related cues. This study involves a screening visit, followed by one MRI visit, followed by ten cTBS treatment visits on consecutive days. There will be three follow-up MRI visits: the first will immediately follow completion of a 28-day outpatient treatment program, while the second and third will be one month and two months post-treatment.

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

Effect of approach bias modification on cue-reactivity in individuals with cannabis use disorder. Save

Date Added
October 6th, 2015
PRO Number
Pro00048215
Researcher
Brian Sherman
Keywords
Drug Studies, Psychiatry, Substance Use
Summary

Biases in cognitive processing of drug-related stimuli are central to the maintenance of addiction and contribute to poor treatment outcome. This study will evaluate how people who frequently use marijuana respond to marijuana cues, and if a computerized task affects this response. During the two week study period participants will engage in four computer task sessions, and response to marijuana cues will be assessed directly before and after the two-week study period. Two weeks after the last study visit, marijuana cue response and computer task performance will again be assessed. Marijuana use will be tracked throughout the study and follow-up periods.

You may be eligible if you:
Are between the ages of 18 and 65.
Smoke marijuana.
Are willing to provide informed consent.

Eligible participants may receive compensation.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

Theta Burst TMS as a Tool to Change Smoking Behavior Save

Date Added
May 5th, 2015
PRO Number
Pro00042165
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Smoking
Summary

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

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

rTMS as a Tool to Decrease Pain and Opiate Craving Save

Date Added
April 7th, 2015
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

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