Advancing Couple and Family Alcohol Treatment through Patient-Oriented Research and Mentorship

Date Added
April 4th, 2023
PRO Number
Pro00127577
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.

This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA). EMA includes very short surveys (5 minutes or less) that participants respond to on a smartphone application. Participants will be asked to respond to these surveys in the morning and three additional times throughout the day.

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

Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

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

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Date Added
June 6th, 2023
PRO Number
Pro00128800
Researcher
Lindsay Squeglia

List of Studies


Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

This study is testing citicoline as a possible medication to treat alcohol use disorder. Youth (ages 16-22) will be randomly assigned to receive either citicoline (2000mg per day) and or a placebo for four weeks.

All participants will receive brief counseling from a trained clinician and will undergo a brain scan and cognitive testing at the beginning and end of the treatment.

Participants must provide informed consent and youth under 18 must have parental consent to participate. The full study will last approximately one month.

Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Cori Herring
843-792-8207
herrinco@musc.edu

BEACON: A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients with Sickle Cell Disease and Severe Vaso-Occlusive Crises

Date Added
June 13th, 2023
PRO Number
Pro00121176
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a research study to find out if the study drug called BEAM-101 is safe and effective in the treatment of patients with severe Sickle cell disease (SCD). The study drug, BEAM-101 is a new investigational (experimental) therapy that is the first in human use of this drug.

The study medication uses patients' own stem cells that are harvested through apheresis (process where blood is removed, stem cells collected and blood is returned), changed by genetic modification, and transplanted back into the individual through intravenous infusion to treat severe SCD.

Participation in this study is expected to last approximately 24 months, starting at time of screening, through the collection of cells, transplantation of study drug, and 15-month follow-up period. Study visits during the screen and mobilization period will vary depending on the cell collection process, in other words, the mobilization and collection period could be 3 separate visits to harvest adequate stem cells. Subjects are then hospitalized for the conditioning period, transplantation of study drug and engraftment period (when blood counts return to normal). The follow up visits after discharge from the hospital will be monthly for the first 6 months, then every other month until 24 months post transplant period.

At the end of the 24 months, all participants will be asked to enroll in the long-term extension study for a duration of 13 years making the total follow-up period of 15 years.

Institution
MUSC
Recruitment Contact
Brandi Day
843-792.3379
dayb@musc.edu

A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas aeruginosa Infection

Date Added
June 14th, 2023
PRO Number
Pro00128304
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of AP-PA02 administered by inhalation. This study will evaluate AP-PA02 administration in stable NCFB (non-cystic fibrosis bronchiectasis) patients. Subjects will either be included in Cohort A or Cohort B. For Cohort A, subjects will be randomized to receive either inhaled AP-PA02 or placebo. Cohort A will include individuals with NCFB and confirmed chronic P. aeruginosa infection but not on chronic inhaled antibiotics. These individuals will receive wither AP-PA02 or placebo for 10 days twice a day.
Cohort B will include individuals who with NCFB and confirmed P. aeruginosa infection but who are on chronic antibiotics. These individuals will receive either AP-PA02 or placebo for 10 days plus their current inhaled antibiotics for 28 days.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma

Date Added
June 20th, 2023
PRO Number
Pro00127066
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer
Summary

This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated Radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. Participation in the study will take about 15 visits over a period of 15 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Impact of capturing ictal events with ultra-long-term ambulatory EEG monitoring with REMI.

Date Added
June 27th, 2023
PRO Number
Pro00129426
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This study is being done to understand whether a different type of electroencephalography (EEG) monitoring that permits longer monitoring is able to capture more seizures than regular EEG monitoring, and whether this new type of monitoring will improve clinical care. This type of EEG monitoring (REMI) is currently cleared by the United States Government Food and Drug Administration (or FDA) for use in hospitals but not yet cleared to be used at home.
Eligible subjects who have EEG monitoring scheduled with either a 3-day EEG monitoring performed at home or with a 3-day EEG monitoring schedule at the Medical University of South Carolina (MUSC). Subjects are in the study for approximately 4 weeks and will need to come to the study center for one or two visits. They will be asked to wear 4 of Epitel's REMI Sensors on their head, in addition to the regular EEG electrodes, for two 2-week REMI EEG monitoring periods. A 2nd visit (clinic visit) at MUSC may be needed if the recording is at MUSC, in order to start the second REMI EEG monitoring session.
At the end of the study, three independent epileptologists will review the REMI EEG recordings and compile a report of any findings. They will then provide this report to the subject's neurologist who will assess the value of the additional EEG information, and save the report within the MUSC medical record.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu



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