Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT05786157

Conditions

Alcohol Use Disorder

Posttraumatic Stress Disorder

Couples

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Alcohol Administration

Study Details

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

Study ID

NCT05786157

Start date

Mar 1, 2024

Status verified date

Apr, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: alcohol administration paradigm

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

Interventions

Alcohol Administration

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

Primary outcome measure

  • Laboratory intimate partner aggression [ Time Frame: 2 hours ]
  • Naturalistic intimate partner aggression [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Stacey Sellers

843-792-5807sellersst@musc.edu

Julianne Flanagan

hellmuth@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Stacey Sellers

8437925807sellersst@musc.edu

Principal Investigator:

Julianne Flanagan, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-03.