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

Primary Purpose

Alcohol Use Disorder, Posttraumatic Stress Disorder, Couples

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alcohol Administration
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 TimeLine Follow Back,TLFB). At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the Conflict Tactics Scale, 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 (assessed by the Clinicial Administered Posttraumatics Stress Scale, CAPS-5). Exclusion Criteria: Possible alcohol or drug use disorder (except caffeine or nicotine) as defined by the Alcohol Use Disorders Identification Test, AUDIT scores >8 or Drug Abuse Screening Test DAST scores >3; meeting Diagnostic and Statistical Manual of Mental Disorders, DSM-5 diagnostic criteria; or having ever sought treatment for alcohol or drug use disorder. Recent recreational drug use (e.g., cannabis) is acceptable. 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). 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. Pregnancy or breastfeeding. Severe or unilateral partner violence in the past 6 months as measured by the CTS-2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    alcohol administration paradigm

    Arm Description

    Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)

    Outcomes

    Primary Outcome Measures

    Laboratory intimate partner aggression
    Taylor aggression paradigm
    Naturalistic intimate partner aggression
    self-report using ecological momentary assessment

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05786157
    Brief Title
    Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship
    Official Title
    Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2028 (Anticipated)
    Study Completion Date
    October 1, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder, Posttraumatic Stress Disorder, Couples

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    alcohol administration paradigm
    Arm Type
    Experimental
    Arm Description
    Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)
    Intervention Type
    Other
    Intervention Name(s)
    Alcohol Administration
    Intervention Description
    Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)
    Primary Outcome Measure Information:
    Title
    Laboratory intimate partner aggression
    Description
    Taylor aggression paradigm
    Time Frame
    2 hours
    Title
    Naturalistic intimate partner aggression
    Description
    self-report using ecological momentary assessment
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 TimeLine Follow Back,TLFB). At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the Conflict Tactics Scale, 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 (assessed by the Clinicial Administered Posttraumatics Stress Scale, CAPS-5). Exclusion Criteria: Possible alcohol or drug use disorder (except caffeine or nicotine) as defined by the Alcohol Use Disorders Identification Test, AUDIT scores >8 or Drug Abuse Screening Test DAST scores >3; meeting Diagnostic and Statistical Manual of Mental Disorders, DSM-5 diagnostic criteria; or having ever sought treatment for alcohol or drug use disorder. Recent recreational drug use (e.g., cannabis) is acceptable. 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). 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. Pregnancy or breastfeeding. Severe or unilateral partner violence in the past 6 months as measured by the CTS-2
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stacey Sellers
    Phone
    843-792-5807
    Email
    sellersst@musc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julianne Flanagan
    Email
    hellmuth@musc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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