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

NCT05786157 | Recruiting DMC

• 1 other identifier: Pro00127577
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use Disorder; Posttraumatic Stress Disorder; Couples

Outcome Measures

Primary Outcomes (2)

• Laboratory intimate partner aggression

  Taylor aggression paradigm

  2 hours

• Naturalistic intimate partner aggression

  self-report using ecological momentary assessment

  28 days

Study Arms (1)

alcohol administration paradigm

EXPERIMENTAL

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

Other: Alcohol Administration

Interventions

Alcohol Administration OTHER

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

alcohol administration paradigm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Clinical Administered Posttraumatic Stress Scale, CAPS-5).

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Stacey Sellers

CONTACT

843-792-5807; sellersst@musc.edu

Julianne Flanagan

CONTACT

hellmuth@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

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

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)