Alcohol Use Disorder Clinical Trial
Official title:
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).
Status | Recruiting |
Enrollment | 140 |
Est. completion date | October 1, 2029 |
Est. primary completion date | October 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 TimeLine Follow Back,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 Conflict Tactics Scale, 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 (assessed by the Clinical Administered Posttraumatic Stress Scale, CAPS-5). Exclusion Criteria: 1. 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. 2. Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders. 3. Current suicidal or homicidal ideation and intent. 4. History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated. 5. Body weight > 250 lbs (in order to rigorously control alcohol dosing). 6. 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. 7. Pregnancy or breastfeeding. 8. Severe or unilateral partner violence in the past 6 months as measured by the CTS-2 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laboratory intimate partner aggression | Taylor aggression paradigm | 2 hours | |
Primary | Naturalistic intimate partner aggression | self-report using ecological momentary assessment | 28 days |
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