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

Interaction of Depression and Sensorimotor Function: An observational study of neural connectivity following treatment for depression Save

Date Added
December 2nd, 2015
PRO Number
Pro00049197
Researcher
Colleen Hanlon
Keywords
Depression, Psychiatry
Summary

This study seeks to recruit individuals who are scheduled to undergo non-invasive brain stimulation as a treatment for depression. Participants will be recruited through the Brain Stimulation Division in the Institute of Psychiatry at the Medical University of South Carolina. Following enrollment participants will be given a battery of senrorimotor assessments and an MRI scan before they begin brain stimulation treatment and within a week after they end their treatment. The goal of this study is to evaluate the impact of depression on sensorimotor function and the integrity of neural circuits involved in motor control.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-5732
lenchd@musc.edu

Improving PTSD Service Delivery for Veterans with Severe Mental Illness Save

Date Added
December 1st, 2015
PRO Number
Pro00013928
Researcher
Anouk Grubaugh
Keywords
Anxiety, Military, Psychiatry, Stress Disorders
Summary

This study is testing the efficacy of Prolonged Exposure for PTSD (PE) relative to treatment-as-usual in Veterans with severe and persistent mental illness (SMI; schizophrenia, schizoaffective disorder, bipolar disorder, severe unipolar disorder) treated at the Charleston VAMC.

Institution
MUSC
Recruitment Contact
Anouk Grubaugh
843-789-6664
GRUBAUGH@MUSC.EDU

Integrative Risk Reduction and Treatment for Teen Substance Use Problems Save

Date Added
December 1st, 2015
PRO Number
Pro00009042
Researcher
Carla Danielson
Keywords
Adolescents, Alcohol, Anxiety, Depression, Mental Health, Psychiatry, Substance Use
Summary

The study will involve a randomized controlled trial (RCT) with subjects ages 13-18 years (who have experienced sexual assault) randomized to receive Risk Reduction through Family Therapy (RRFT) or Treatment As Usual. Youth will be recruited from 2 local child advocacy centers and the interventions are psychosocial in nature. Follow-up assessments will be conducted at multiple time points through 18-month post entry.

Institution
MUSC
Recruitment Contact
Elizabeth McGuan
843-792-8361
mcguan@musc.edu

Neural substrates of emotion: Impact of cocaine dependence Save

Date Added
December 1st, 2015
PRO Number
Pro00039699
Researcher
Margaret Moran-santa maria
Keywords
Drug Studies, Psychiatry, Stress Disorders, Substance Use
Summary

Social stress often leads to drug craving and relapse in cocaine-dependent populations. Currently there are no FDA approved medications for the treatment of cocaine dependence. Therefore, biomedical research studies aimed at investigating the brain mechanisms responsible for controlling emotional responses to social stress could have a significant impact on the development of effective therapeutic treatment strategies for cocaine-dependent individuals.

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

rTMS for normalizing Emotion Regulation in Substance Use Disorders Save

Date Added
October 7th, 2015
PRO Number
Pro00037704
Researcher
Brett Froeliger
Keywords
Brain, Central Nervous System, Mental Health, Nervous System, Psychiatry, Smoking, Substance Use
Summary

The purpose of this study is to use a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) and brain imaging technique called functional magnetic resonance imaging (fMRI) to investigate the causes of depressive symptoms among nicotine dependent cigarette smokers. Participation in this study will involve 3 visits: a screening/training visit and 2 experimental visits. During the screening/training visit, you will provide biological samples to confirm your eligibility to participate and fill out questionnaires, learn the tasks that you will be performing on during the experimental visits, and become familiar with the tools you will be using and environment you will be in during the experimental visits. On each experimental visit, you will undergo fMRI scanning while performing the tasks practiced at training and receive either rTMS or a control rTMS treatment.

Institution
MUSC
Recruitment Contact
John LeMay
843-792-3084
lemay@musc.edu

Enhancing disrupted reconsolidation: Impact on cocaine craving, reactivity & use Save

Date Added
October 6th, 2015
PRO Number
Pro00021392
Researcher
Michael Saladin
Keywords
Drug Studies, Mental Health, Psychiatry, Substance Use
Summary

Our recently completed study has provided the first evidence that administration of the medication propranolol, following exposure to cocaine cues, can alter drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine addicted persons. The proposed research will use two methods to increase the memory altering effects of propranolol observed in our recently completed study, and document lasting effects not only on craving and cue-elicited reactions, but also on cocaine use. Positive findings will set the stage for a formal clinical trial that could lead to significantly improved treatment outcomes for this treatment-resistant addiction.

Institution
MUSC
Recruitment Contact
Amanda Smith
843-792-6984
smitham@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

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