Evaluation of a Web-Based Tool for Alcohol Use Following Interpersonal Violence

Date Added
September 23rd, 2018
PRO Number
Pro00080368
Researcher
Christine Hahn

List of Studies


Keywords
Alcohol, Substance Use, Women's Health
Summary

The purpose of this study is to gather feedback to inform the development of a web-based tool that provides screening and education about alcohol use following interpersonal violence. People who have experienced sexual assault or domestic violence in the last year and drink alcohol, or are currently in treatment for alcohol use, will be asked to provide feedback about a web-based tool for alcohol use. 60-minute interviews will be conducted and will involve viewing the content of the web-based tool and providing feedback. Additionally, feedback given during interviews will be analyzed and then individuals who have used the web-based tool will complete a survey following the tool use if they report using substances. The tool will be tested for use with English and Spanish speakers.

Additionally, the web-based tool will be adapted for use among SMW and TGD survivors of sexual assault. Two areas of the original tool will be adapted: 1) psychoeducation and normative feedback will be made specific to SMW and TGD people's experiences, and 2) sexual and gender minority stress content will be added (i.e., information about sexual and gender-identity related stressors and their association with distress and alcohol use). We will gather feedback via qualitative interviews from 30 SMW and TGD survivors of sexual assault who report alcohol misuse or heavy drinking in the past month.

Institution
MUSC
Recruitment Contact
Christine Hahn
843-792-0259
hahnc@musc.edu

Oxytocin to Enhance Alcohol Behavioral Couple Therapy

Date Added
November 6th, 2018
PRO Number
Pro00082233
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol, Mental Health, Military, Psychiatry, Substance Use
Summary

This study will examine the efficacy of intranasal oxytocin versus placebo in combination with Alcohol Behavioral Couples Therapy (ABCT) to reduce alcohol use disorder severity. We will also use observational coding and neuroimaging to examine behavioral and neural mechanisms underlying treatment outcomes.

Institution
MUSC
Recruitment Contact
Jessica Brower
843-300-9577
Browerj@musc.edu

Introducing Palliative Care (PC) within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial

Date Added
December 18th, 2018
PRO Number
Pro00084674
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Cancer/Gastrointestinal, Liver, Pain
Summary

This is a two armed multicenter cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. Parallel to this cluster-RCT, a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.

To execute this project, Duke has identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 non-VHA, Academic Medical Centers.

Comparative Approaches:
1.Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person visits at initial, 1 and 3 months.
2.Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

MUSC has been assigned to the Model 2 approach, "Hepatologist led Palliative Care" to be lead by Dr. Don Rockey and Dr. Heather Simpson.

Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu

Neuroimaging to Examine Behavior

Date Added
May 21st, 2019
PRO Number
Pro00087701
Researcher
Amber Jarnecke

List of Studies


Keywords
Alcohol, Anxiety, Brain, Healthy Volunteer Studies, Mental Health, Non-interventional, Stress Disorders, Substance Use
Summary

This study will examine the neural circuitry associated with craving, behavioral disinhibition, and threat-reactivity. The study will involve 2 visits. During the first visit, participants will complete questionnaires and interviews in a private room and do some tests to measure alcohol use. During the second visit, participants will complete a neuroimaging scan of their brain.

Institution
MUSC
Recruitment Contact
Amber Jarnecke
843-779-2159
jarnecka@musc.edu

PROSPECTIVE STUDY OF ACUTE FLACCID MYELITIS (AFM) TO DEFINE NATURAL HISTORY, RISK FACTORS, AND PATHOGENETIC MECHANISMS

Date Added
December 11th, 2019
PRO Number
Pro00094024
Researcher
Stephen Thacker

List of Studies

Keywords
Brain, Infectious Diseases, Nerve, Nervous System, Spinal Cord
Summary

This study is designed to gain a better understanding and natural history of acute flaccid myelitis (AFM).

This study will include reviewing medical records to record information about the medications taken to treat AFM and your social history (smoking, alcohol and drug use). The results of lab tests, imaging studies and tests will also be collected to determine if you have any damage to your nerves that are done by your clinical care team to diagnose your AFM.

Samples from Mouth, nose, stool and blood will be collected as a part of this study. Any remaining spinal fluid that is in the lab from the spinal tap from clinical labs will also be collected. A neurological exam and tests to determine issues with muscles, functionality and strength after being diagnosed with AFM will also be performed as a part of this study.

Institution
MUSC
Recruitment Contact
Sandra Fowler
8437922385
fowlersl@musc.edu

Targeting Parenting to Prevent HIV and Substance Use Among Trauma-Exposed Youth: A Mixed-Methods Needs Assessment

Date Added
March 16th, 2020
PRO Number
Pro00096161
Researcher
Nada Goodrum

List of Studies

Keywords
Adolescents, Alcohol, HIV / AIDS, Mental Health, Psychiatry, Sexually Transmitted Infections (STI), Substance Use
Summary

Many adolescents experience traumatic events, such as child abuse, physical or sexual assault, or witnessing violence. Teens who experience trauma are more likely to have problems with substance use and risky sexual activity. We want to understand how parents can support their teens and help keep them safe after traumatic events.

Institution
MUSC
Recruitment Contact
Nada Goodrum
843-792-8067
goodrumn@musc.edu

Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

Date Added
May 5th, 2020
PRO Number
Pro00099114
Researcher
Selime Salim

List of Studies

Keywords
Women's Health
Summary

This study is for women who have experienced a sexual assault in the past twelve weeks and use alcohol. The research involves completing a five to seven week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Date Added
September 1st, 2020
PRO Number
Pro00102709
Researcher
Lisa McTeague

List of Studies


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

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
(843) 792-1222
alcoholstudy@musc.edu

Alcohol Research Center. Shared clinical assessment core for the Alcohol Research Center clinical projects.

Date Added
October 6th, 2020
PRO Number
Pro00103760
Researcher
Konstantin Voronin

List of Studies


Keywords
Alcohol, Drug Studies
Summary

The purpose of this research study is to determine potential subjects eligibility for participation in the Alcohol Research Center clinical projects based on the results of the screening assessments, which they will complete during this protocol.
Participants will undergo 1-2 days screening procedures. Subjects will be asked to fill out questionnaires, they will be interviewed, will need to provide medical history and have physical exam done and provide a blood sample. Total study consists 1-2 visits which will be completed within approximately one-week period.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

Effects of a Novel mGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder

Date Added
October 6th, 2020
PRO Number
Pro00102334
Researcher
James Prisciandaro

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

This Phase II clinical research study evaluates both the safety and effectiveness of an FDA-regulated medication presently in the initial stages of development for alcohol use disorder treatment (GET73), and will test whether GET73 alters brain chemicals and function, response to alcohol ingestion, and the desire for alcohol. Participants will be randomly assigned to one of two medication treatment groups (GET73 or placebo). Study medication will be taken for 8 days, with approximately 4 study visits, and a "bar-lab" procedure and 2 MRI brain imaging scans will be completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-0572
hixs@musc.edu



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