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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT04582695
Eligibility Criteria:
Inclusion Criteria:
* Female; any race or ethnicity; age 18 to 65 years old.
* Sexual assault that occurred within the past 12 months.
* Subjects must be able to comprehend English.
* A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen.
* A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive-compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice.
* Must consent to complete all treatment and follow-up visits.
Exclusion Criteria:
* Lack of any memory of the sexual assault
* Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.
* Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
* Individuals considered an immediate suicide risk, with current suicidal ideation and intent.
* Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment.
* Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.
* Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04582695
Study Brief:
Protocol Section:
NCT04582695