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

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).

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder; Alcohol Use Disorder; Couples
• Intervention / Treatment: Other: Alcohol Administration

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey Sellers; Phone Number: 843-792-5807; Email: sellersst@musc.edu
• Study Contact Backup: Name: Julianne Flanagan; Email: hellmuth@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Julianne Flanagan, PhD
      • Contact: Stacey Sellers; Phone Number: 8437925807; Email: sellersst@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Any gender identity; any race or ethnicity; ages 21 years or older.
2. 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).
3. 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).
4. Participants must agree not to drive or operate machinery for the remainder of the experimental visit day. Transportation will be provided if necessary.
5. 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).

Exclusion criteria:

1. 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.
2. Severe alcohol use disorder as meeting DSM-5 diagnostic criteria via the QuickSCID. Applies to those receiving alcohol administration only.
3. Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
4. Current suicidal or homicidal ideation and intent.
5. History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated.
6. Body weight > 250 lbs (in order to rigorously control alcohol dosing). Applies to those receiving alcohol administration only.
7. 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.
8. Pregnancy or breastfeeding.
9. Severe or unilateral partner violence in the past 6 months as measured by the CTS-2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alcohol administration paradigm; Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)	Other: Alcohol Administration; Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory intimate partner aggression	Taylor aggression paradigm	2 hours
Naturalistic intimate partner aggression	self-report using ecological momentary assessment	28 days

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Stress Disorders, Traumatic; Alcoholism; Stress Disorders, Post-Traumatic; Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: Pro00127577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No