CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL

Date Added
July 6th, 2015
PRO Number
Pro00043906
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy procedure plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenting plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

A prospective trial of varenicline and incentives for tobacco cessation in adults

Date Added
April 6th, 2019
PRO Number
Pro00086954
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication called varenicline, counseling and financial incentives among those who use tobacco and cannabis/marijuana. All participants will receive tobacco cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis/marijuana. You do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.

Institution
MUSC
Recruitment Contact
Kemi Chukwuka
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

A prospective trial of varenicline and incentives for tobacco cessation in adults

Date Added
April 6th, 2019
PRO Number
Pro00086954
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication called varenicline, counseling and financial incentives among those who use tobacco and cannabis/marijuana. All participants will receive tobacco cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis/marijuana. You do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Kemi Chukwuka
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination

Date Added
May 5th, 2020
PRO Number
Pro00098479
Researcher
Matthew Carpenter

List of Studies


Keywords
Smoking
Summary

This is a research study to find out if smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample.

Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study.

The study lasts for six months, and will involve six total surveys. In addition, we ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.

Institution
MUSC
Recruitment Contact
Yunuen Lupian
843-876-2441
lupian@musc.edu

Contingency Management to Promote Smoking Abstinence in Cancer Patients

Date Added
May 29th, 2020
PRO Number
Pro00099446
Researcher
Benjamin Toll

List of Studies


Keywords
Cancer, Smoking
Summary

This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.

Institution
MUSC
Recruitment Contact
Rachel Christian
843-737-1516
chrisrac@musc.edu

Down syndrome biomarker project

Date Added
June 25th, 2020
PRO Number
Pro00090922
Researcher
Eric Hamlett

List of Studies


Keywords
Alzheimers, Blood Disorders, Brain, Children's Health, Dementia, Inflammation, Vascular
Summary

Alzheimer's disease and Epilepsy may affect over 80% of individuals that have Down syndrome by the age of 60. Biomarkers found in the blood can enhance our understanding of the earliest changes linked to disease and may enhance clinical detection and healthy aging for individuals with Down syndrome.

The purpose of this study is to discover early neurobiological processes underlying the transition from healthy aging to disease. Our research team has developed technology that allows detection of small changes in the brain that get transferred to the blood.

We are recruiting individuals that either have or do not have Down syndrome for this biomarker study. Participants should be between the ages of 6 months and 85 years old and may include mothers and siblings of a child with Down syndrome. Infants and children will require consent form a parental or legal guardian.

Each participant will provide a blood sample for research purposes. We will also gather some basic health information about senses, habits, exercise level and smoking/vaping exposures.

Institution
MUSC
Recruitment Contact
Eric Hamlett
919 357 7543
hamlette@musc.edu

RTMS manipulates imbalanced drive-reward and executive control circuitry for smoking cessation

Date Added
March 2nd, 2021
PRO Number
Pro00105723
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, we will use brain MRI to guide TMS therapy for smoking cessation.

Institution
MUSC
Recruitment Contact
Xingbao Li
(843) 792-5729
lixi@musc.edu

The American Lung Association (ALA) Lung Health Cohort (LHC)

Date Added
November 12th, 2021
PRO Number
Pro00108970
Researcher
Charlie Strange

List of Studies


Keywords
Healthy Volunteer Studies, Lung, Pulmonary
Summary

A main focus of the study is to identify characteristics that can be changed such as smoking, vaping and diet, environmental exposures (e.g. pollution such as car exhaust, allergies such as pet dander) that affect lung function and risk of future lung disease. We also are looking for biomarkers (e.g. measurements of specific substances in nose, blood, and urine samples) and genetic markers that can provide us with information about lung health. The findings in this study are considered research and are not the same as "genetic testing."

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

Impact of cigarette and e-cigarette menthol regulation on current smokers of menthol cigarettes.

Date Added
October 4th, 2022
PRO Number
Pro00122898
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, we will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, we will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Institution
MUSC
Recruitment Contact
Yunuen Lupian
843-876-2441
lupian@musc.edu

Impact of cigarette and e-cigarette menthol regulation on current smokers of menthol cigarettes.

Date Added
October 4th, 2022
PRO Number
Pro00122898
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, we will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, we will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Yunuen Lupian
843-876-2441
lupian@musc.edu



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