A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

Date Added
April 6th, 2023
PRO Number
Pro00124137
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Liver
Summary

To evaluate the efficacy of an investigational medication (INT-787) as assessed by disease progression in severe alcohol-associated hepatitis (sAH).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

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

Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial

Date Added
February 8th, 2023
PRO Number
Pro00126431
Researcher
Sudie Back

List of Studies


Keywords
Alcohol, Mental Health
Summary

A large proportion of individuals with alcohol use disorder (AUD) also meet criteria
for posttraumatic stress disorder (PTSD). Trauma-focused, cognitive-behavioral therapy delivered alongside interventions for substance use disorders are most effective. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and effective treatments for these
conditions. The purpose of this study is to examine the CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD.

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

Development and Testing of COPEWeb: A Web-Based Provider Training for Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)

Date Added
November 23rd, 2022
PRO Number
Pro00123952
Researcher
Sudie Back

List of Studies


Keywords
Alcohol
Summary

The need to advance knowledge and increase access to treatment for co-occurring posttraumatic stress disorder (PTSD) and substance use disorders (SUD) is a priority for service members and Veterans. PTSD and SUD often co-occur and are two of the most common and debilitating mental health disorders among service members and Veterans. However, few providers are trained in this approach and therefore are not prepared to deliver best practice care to Veterans who need integrated PTSD/SUD treatment.
This project will directly address this critical gap in provider training to improve the care of Veterans with comorbid PTSD/SUD, by providing development and testing of a web-based provider training course for concurrent treatment of PTSD and SUD Using prolonged exposure (COPE).

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

Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder among Veterans

Date Added
September 6th, 2022
PRO Number
Pro00121552
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol, Military, Stage II
Summary

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans.

The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy.

This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual, TAU (i.e., B-FIT + CBT treatment) as compared to TAU alone (i.e., CBT treatment). Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 & 6 month follow-up assessments, all via telehealth.

Institution
MUSC
Recruitment Contact
Alexander Hannegan
843-7920608
alh324@musc.edu

An investigation of reward brain circuitry structure and function in individuals with co-occurring alcohol use disorder and bipolar disorder and their unaffected offspring

Date Added
October 5th, 2021
PRO Number
Pro00114068
Researcher
Will Mellick

List of Studies


Keywords
Adolescents, Alcohol, Brain, Depression, Mental Health, Substance Use
Summary

The purpose of this two-visit brain imaging (magnetic resonance imaging, MRI) study is to identify brain targets for improving treatment and preventative interventions for individuals at risk for co-occurring bipolar disorder and alcohol use disorder. The preliminary visit for a parent and his/her biological child will include completion of clinical interviews, surveys, and labwork to determine study eligibility. If they are considered eligible for the study, brain imaging visits will occur within 1-2 weeks at which a 1-hour MRI will be completed along with additional clinical interviews, surveys, and labwork. Brief follow-up phone call interviews will be completed with participants every 3 months for 1 year. Study participation is confidential and compensated.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-7500
hixs@musc.edu

Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use

Date Added
March 2nd, 2021
PRO Number
Pro00106723
Researcher
Austin Hahn

List of Studies

Keywords
Adolescents, Alcohol, Substance Use
Summary

The study will test a computerized treatment with subjects ages 13-17 years who are interested in seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-792-5200
boatrigh@musc.edu

Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD

Date Added
November 3rd, 2020
PRO Number
Pro00103198
Researcher
Sudie Back

List of Studies


Keywords
Alcohol, Mental Health, Military, Psychiatry, Stress Disorders
Summary

The purpose(s) of the research is to test a new medication in combination with a talk therapy for Veterans experiencing posttraumatic stress disorder (PTSD) and who may have alcohol use disorder (AUD). The study consists of 12 weekly therapy sessions. Once per week before each therapy session, an intranasal dose of investigational medication will be administered. The study also involves 3 and 6-month follow-up appointments and the administration of questionnaires at each visit.

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