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

Medical University of South Carolina1 个研究点分布在 1 个国家目标入组 140 人2024年3月1日

适应症Alcohol Use Disorder Posttraumatic Stress Disorder Couples

干预措施Alcohol Administration

概览

阶段: 不适用
干预措施: Alcohol Administration
疾病 / 适应症: Alcohol Use Disorder
发起方: Medical University of South Carolina
入组人数: 140
试验地点: 1
主要终点: Naturalistic intimate partner aggression
状态: 招募中
最后更新: 29天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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).

详细描述

Alcohol misuse has a salient precipitous effect on intimate partner violence (IPV), which is a persistent public health crisis affecting approximately one-third of the U.S. population. Posttraumatic stress disorder (PTSD) is highly prevalent, has a clear causal effect on alcohol misuse, and it is a robust independent predictor of IPV. However, few studies have examined the combined effects of PTSD and alcohol misuse on IPV. This question is critical to address because effective prevention and treatment approaches for alcohol-related IPV are scant. Integrating these two siloed areas of the literature can help inform the development of novel, trauma-informed modalities for couples to produce stronger and more sustainable outcomes. Dr. Flanagan is the ideal candidate to advance the clinical science in this area. Under the proposed mid-career development award, she will accelerate her thriving patient-oriented alcohol research program by enhancing her skills with 1) oral alcohol administration, 2) intensive ambulatory assessment, and 3) psychophysiology. She will achieve these goals through expert consultation, didactic training, and implementation of the proposed research project. Her team will examine the combined effects of alcohol misuse and PTSD on alcohol-related IPV among couples (N=70) in both a controlled laboratory setting and in naturalistic settings. The study, which was designed to complement mentees' independent research interests, will also compare outcomes across settings and explore heart rate variability as a physiological mechanism underlying the hypothesized relations. The invaluable protected time and resources provided by this K24 will enable Dr. Flanagan to achieve her primary goal of expanding her mentoring availability and skillset at this pivotal mid-career stage. She will engage a program of didactics and expert coaching to amplify her investment in diversity, equity, and inclusion in mentoring, leadership, and science. Achieving these synergistic objectives will accelerate the science of couple and family alcohol research and set the stage for innovative new dyadic treatments. This award will also ensure that Dr. Flanagan is equipped to support the next generation of enthusiastic new investigators and to ensure the longevity of this vital yet underrepresented area of the alcohol field.

注册库

clinicaltrials.gov

开始日期

2024年3月1日

结束日期

2029年10月1日

最后更新

29天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Medical University of South Carolina

责任方

Principal Investigator

主要研究者

Julianne Flanagan

Associate Professor-Faculty

Medical University of South Carolina

入排标准

入选标准

•Any gender identity; any race or ethnicity; ages 21 years or older.
•Must report ≥ 2 heavy drinking episodes in the past 30 days (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) and consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory (assessed via the TLFB).
•At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the CTS-2).
•Participants must agree not to drive or operate machinery for the remainder of the experimental visit day. Transportation will be provided if necessary.
•One or both partners in half the couples will be required to meet diagnostic criteria for PTSD or subthreshold PTSD (assessed by the CAPS-5).

排除标准

•Possible drug use disorder (except caffeine or nicotine) as meeting DSM-5 diagnostic criteria via the QuickSCID; Recent recreational drug use (e.g., cannabis) is acceptable.
•Severe alcohol use disorder as meeting DSM-5 diagnostic criteria via the QuickSCID. Applies to those receiving alcohol administration only.
•Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
•Current suicidal or homicidal ideation and intent.
•History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated.
•Body weight \> 250 lbs (in order to rigorously control alcohol dosing). Applies to those receiving alcohol administration only.
•Use of medications such as lithium, methadone, alpha or beta blockers or cholinergic/ anticholinergic drugs likely to confound normative cardiovascular responding for the psychophysiological component of the project. Applies to those receiving alcohol administration only.
•Pregnancy or breastfeeding.
•Severe or unilateral partner violence in the past 6 months as measured by the CTS-2.