A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD) Save

Date Added
June 27th, 2017
PRO Number
Pro00064375
Researcher
Mark George
Keywords
Depression, Military, Psychiatry, Stress Disorders
Summary

Objectives: The aim of the study is to evaluate the efficacy and safety of DTMS for the treatment of PTSD.
Patient Population: 176 male and female subjects, 22-68 years of age, currently diagnosed with PTSD according to the DSM-V criteria.
Structure: A randomized, controlled, prospective, 9 week, double blind, multicenter study.
Blinding: The treatment administrator, study rater, all study personnel and patients will be blinded to the treatment being administered.
Concurrent Control: The study group will receive active DTMS treatment and the control group will receive inactive, sham treatment.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843 577 5011 ext 5209
matthew.schmidt@va.gov

Feasibility and acceptability of an mHealth cognitive behavioral stress management intervention to ameliorate HIV-related fatigue Save

Date Added
August 25th, 2016
PRO Number
Pro00057504
Researcher
Julie Barroso
Keywords
HIV / AIDS, Stress Disorders
Summary

HIV-related fatigue is a serious problem for those infected with the virus. We believe that cognitive behavioral stress management is a good solution since stress is the most consistent predictor of increases in fatigue for this group. We want to convert an already proven curriculum to an mHealth format to extend the reach of this intervention.

Institution
MUSC
Recruitment Contact
Julie Barroso
843-792-2110
barroso@musc.edu

A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid PTSD Save

Date Added
August 2nd, 2016
PRO Number
Pro00056889
Researcher
Elizabeth Santa ana
Keywords
Alcohol, Anxiety, Stress Disorders, Substance Use
Summary

We are currently recruiting women and men ages 18-70 who have had trauma experience and who use alcohol. This research study includes 12 weekly therapy sessions as well as random assignment to receive either the study medication or placebo.
The study will examine the ability of N-acetylcysteine (NAC), an antioxidant/dietary supplement, to reduce the severity of alcohol cravings and withdrawal as well as symptoms associated with PTSD.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Glial Regulators for Testing Comorbid Posttraumatic Stress Disorder and Substance Use Disorders Save

Date Added
March 1st, 2016
PRO Number
Pro00052757
Researcher
Sudie Back
Keywords
Alcohol, Anxiety, Military, Stress Disorders, Substance Use
Summary

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, medical problems, reduced resiliency and military readiness, vocational problems, and family/social impairment.Determine the benefits of N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress disorder (PTSD) among military Veterans.

Institution
MUSC
Recruitment Contact
Jacelyn Lane
843-792-3788
lanejac@musc.edu

Impact of Oxytocin on Neurobiologic Substrates of Social Stress in Individuals with Alcohol Use Disorder Save

Date Added
January 5th, 2016
PRO Number
Pro00050913
Researcher
Lisa Mcteague
Keywords
Alcohol, Stress Disorders
Summary

Social stress plays a significant role in alcohol craving and relapse. The purpose of this study is to examine the effects of oxytocin on brain areas involved in regulating emotion in response to social stress in individuals with alcohol use disorder.

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

Mindfulness Meditation for the treatment of women with comorbid PTSD and SUD Save

Date Added
November 3rd, 2015
PRO Number
Pro00048115
Researcher
Therese Killeen
Keywords
Complementary Medicine, Stress Disorders, Substance Use
Summary

The current study will modify an already existing therapy for individuals with substance use disorders to address PTSD in women enrolled in SUD treatment who suffer with both PTSD and SUD. Mindfulness meditation has been shown to help individuals to cope with stress and regulate emotions. Through meditation practice women will experience less distress related to PTSD symptoms and reduced substance use in response to emotional triggers. Women enrolled in intensive SUD treatment at a community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months' follow-up.

Institution
MUSC
Recruitment Contact
Therese Killeen
843-792-5232
killeent@musc.edu

Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders Save

Date Added
June 2nd, 2015
PRO Number
Pro00042941
Researcher
Sudie Back
Keywords
Alcohol, Drug Studies, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to evaluate the effects of a medication (doxazosin) on reducing symptoms of posttraumatic stress disorder (PTSD) and substance use in Veterans. We will also examine the effects of doxazosin on brain activity at pre and post treatment.

Institution
MUSC
Recruitment Contact
Aisling Henschel
843-789-7193
henschel@musc.edu

Neural substrates of emotion: Impact of cocaine dependence Save

Date Added
December 2nd, 2014
PRO Number
Pro00039699
Researcher
Aimee Mc Rae
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

Prolonged exposure for PTSD with and without Yohimbine: A randomized controlled trial Save

Date Added
February 6th, 2014
IRB Number
19438
Researcher
Peter Tuerk
Keywords
Anxiety, Men's Health, Mental Health, Military, Stress Disorders
Summary

The goal of this study is to assess if the use of a one time dose of Yohimbine, an herbal supplement with effects similiar to a caffine pill or a five hour energy drink, when given in combination of the evidence based treatment for PTSD, Prolonged Exposure (PE), reduces PTSD symptoms more quickly. This study is being conducted at the Charleston VA and will involve approximately 40 male Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans from ages 18-45. Compensation is provided for study participation. Participation in the study will last approximately 10 weeks, followed by one assessment three months after the completion of the study.

Institution
MUSC
Recruitment Contact
Bridgette Niepoth
843-789-6652
bridgette.niepoth@va.gov

Improving PTSD Service Delivery for Veterans with Severe Mental Illness Save

Date Added
December 6th, 2011
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

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