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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT06002633
Eligibility Criteria:
1. Inclusion criteria for all participants:
* between 21 and 60 years of age
* having consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year
2. Inclusion criteria for PTSD participants:
\- Meeting diagnostic criteria for PTSD, confirmed by structured interview
3. For all subjects exclusion criteria include:
* history of significant medical illness, particularly if possible changes in cerebral tissue
* neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
* full Scale IQ \<85
* contraindication to MRI scanning
* positive pregnancy test
* severe alcohol use disorder
* current severe cannabis use disorder
* any current substance use disorder (other than alcohol, cannabis, or nicotine)
* scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
* ever being in an abstinence-oriented treatment program for alcohol use
* reporting wanting to quit drinking but not being able to
* any medical, religious, or other reasons for not drinking alcohol
* history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
* an adverse reaction to alcoholic beverages
* reporting never consuming 4 (men) or 3 (women) or more drinks on at least two occasions over the last year
* unwillingness to have a friend or family member drive them home after the alcohol administration sessions
4. Additional exclusion criteria for participants in PTSD and IPV-exposed but no PTSD groups:
* not taking medications for \>4 weeks (i.e. participants must be stable on meds)
* acute suicidality with intent
5. Additional exclusion criteria for participants in IPV-exposure but no PTSD group:
\- history of PTSD
6. Additional exclusion criteria for healthy comparison subjects also include:
* any prior psychiatric hospitalizations
* lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, suicide attempt, or eating disorder
* greater than 1 month of lifetime psychotropic medication
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT06002633
Study Brief:
Protocol Section:
NCT06002633