NCT05786157 Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship
| NCT ID | NCT05786157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-03-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05786157 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05786157 currently recruiting?
Yes, NCT05786157 is actively recruiting participants. Contact the research team at sellersst@musc.edu for enrollment information.
Where is the NCT05786157 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05786157 clinical trial?
NCT05786157 is sponsored by Medical University of South Carolina. The trial plans to enroll 140 participants.