Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT05786157
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05786157
Study Brief:
Protocol Section:
NCT05786157