Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde
Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

Impact of lofexidine on stress, craving and opioid use Save

Date Added
September 4th, 2018
PRO Number
Pro00081381
Researcher
Kathleen Brady
Keywords
Drug Studies, Psychiatry
Summary

The purpose of this study is to determine if the medication lofexidine, taken together with buprenorphine, is more effective at reducing opiate craving, use and stress response than buprenorphine alone, and to see if this effect is different for men and women. Participants are randomly assigned to add either lofexidine or placebo to their buprenorphine treatment for five weeks. They return at the end of five weeks to participate in a stress task. Throughout the study, participants complete "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) twice a day. These sessions include looking at stressful and neutral pictures and rating stress and craving.

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

Impact of progesterone on stress reactivity and cannabis use Save

Date Added
September 4th, 2018
PRO Number
Pro00081360
Researcher
Aimee Mc Rae
Keywords
Drug Studies, Psychiatry
Summary

The purpose of the study is to determine if the hormone progesterone affects marijuana users' stress response and marijuana use. Participation lasts approximately three weeks. During the first week, participants are randomly assigned to take either progesterone or placebo and remain abstinent from marijuana. They return at the end of the week to participate in a stress task. Throughout the three weeks, participants complete "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) three times a day. These sessions include looking at stressful and neutral pictures and rating stress and craving.

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

H-coil TMS to reduce pain: A pilot study evaluating relative efficacy of the H1 vs H7 coil Save

Date Added
July 3rd, 2018
PRO Number
Pro00079129
Researcher
Colleen Hanlon
Keywords
Pain, Psychiatry
Summary

Chronic pain is a serious public health problem with estimates as high as nearly half of the adult population experiencing some form of pain that lasts for more than 6 months. This issue negatively impacts quality of life, is financially burdensome, and has contributed to the opioid crisis in the United States. Therefore, a non-pharmacologic, non-invasive approach for alleviating chronic pain like prefrontal repetitive transcranial magnetic stimulation (rTMS) is an appealing avenue for research into chronic pain management. While rTMS has already been approved for use in treating depression, it has shown promise in treating chronic pain as well. However, there is a debate about which coil designs are most effective and which regions of the brain respond best to rTMS therapy. This study will examine the use of two novel coil designs the H1 coil which is designed to increase activity of the dorsolateral prefrontal cortex and the H7 coil which is designed to decrease activity of the medial prefrontal cortex. To evaluate the efficacy of the two treatment strategies, patients will undergo thermal pain testing before and after the rTMS interventions. The relative efficacy of these two treatment strategies will be useful for establishing rTMS as an effective strategy for chronic pain management and determining the direction for future rTMS research.

Institution
MUSC
Recruitment Contact
John McLeod
843-792-6402
mcleodjo@musc.edu

Developing brain stimulation as a treatment for chronic pain in opiate dependent individuals Save

Date Added
July 3rd, 2018
PRO Number
Pro00078668
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Pain, Psychiatry
Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing pain in individuals with chronic pain. 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. The results of this study will be used to design and develop a large clinical trial of rTMS as an innovative, new treatment option for chronic lower back pain in individuals that have used chronic opiates.

Institution
MUSC
Recruitment Contact
Julia Imperatore
843-792-5560
imperato@musc.edu

Improving Function Through Primary Care Treatment of PTSD Save

Date Added
July 3rd, 2018
PRO Number
Pro00078946
Researcher
Ronald Acierno
Keywords
Anxiety, Depression, Mental Health, Military, Psychiatry
Summary

This research is taking place at the Ralph H. Johnson VAMC and surrounding Community-Based Outpatient Clinics (CBOCs). This study is examining the effectiveness of PE-PC in VHA primary care mental health integration (PCMHI) clinics. We will randomize Veterans presenting in VA PC with chronic PTSD who meet minimal inclusion/exclusion criteria to receive PE-PC (four, 30-minute weekly sessions) or PCMHI treatment as usual.

Institution
MUSC
Recruitment Contact
Stephanie Zeigler
843-789-6519
zeigls@musc.edu

Approach bias modification for the treatment of cannabis use disorder Save

Date Added
May 1st, 2018
PRO Number
Pro00077532
Researcher
Brian Sherman
Keywords
Psychiatry, Substance Use
Summary

This study will evaluate the effect of counseling plus Approach Bias Modification on cannabis use and craving in people with cannabis use disorder. The study consists of a screening visit, four treatment visits and two follow-up visits. Participants will have 4 sessions of counseling, 4 sessions of Approach Bias Modification, and 3 cue reactivity sessions.

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

Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout from Prolonged Exposure Save

Date Added
April 3rd, 2018
PRO Number
Pro00075914
Researcher
Ronald Acierno
Keywords
Anxiety, Depression, Mental Health, Military, Psychiatry
Summary

Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of a Veteran who has successfully completed this treatment in the past. Participants may receive a PE "Workout Buddy." This peer will meet them at the in vivo exposure therapy location and offer support an encouragement while the patient remains in that location. Participants may receive a PE general support peer. This peer will contact them once per week to check in about treatment progress and encourage session attendance, as well as discuss any life stresses. As the PTSD treatment standards in Charleston and other VA sites across the country increasingly include telemedicine delivered care, both in person and telemedicine based exposure therapy recipients will be included.

Institution
MUSC
Recruitment Contact
Stephanie Zeigler
843-789-6519
zeigls@musc.edu

QuitFast: Evaluating transcranial magnetic stimulation as a tool to reduce smoking directly following a quit attempt Save

Date Added
February 6th, 2018
PRO Number
Pro00074769
Researcher
Colleen Hanlon
Keywords
Brain, Psychiatry, Smoking, Substance Use
Summary

The first week after attempting to quite cigarette smoking is the hardest period to succeed. Research shows that individuals able to remain cigarette free for this first week are significantly more likely to quit the smoking habit. In this study, sponsored by the National Institutes of Health, we are evaluating a new tool to assist individuals with quitting cigarette smoking. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether 10 daily sessions of TMS over the forehead can help decrease smoking rates in treatment-seeking individuals.

Institution
MUSC
Recruitment Contact
Julia Imperatore
843-792-5560
imperato@musc.edu

Theta-Burst Stimulation As A Tool To Change Smoking Behavior Save

Date Added
February 6th, 2018
PRO Number
Pro00074722
Researcher
Colleen Hanlon
Keywords
Drug Studies, Psychiatry, Smoking
Summary

The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst 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 tbTMS over the forehead can produce a reduction in things that may prompt you to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions.

This study consists of one consent session and one TMS session (can be on same day). Subjects will be asked to complete a series of questionnaires and computer assessments on how you think about nicotine and one session of TMS will be completed.

Institution
MUSC
Recruitment Contact
Julia Imperatore
(843)-792-5560
imperato@musc.edu

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