Eligibility Module

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 @ 2:26 AM
Ignite Modification Date: 2025-12-25 @ 2:26 AM
NCT ID: NCT04581434
Eligibility Criteria: INCLUSION CRITERIA: 1. Initiate an episode of outpatient SUD treatment at an enrolled facility. 2. meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone is not sufficient for inclusion). 3. Report substance use in the past 30 days (or in the 30 days prior to entering a controlled environment if exiting said controlled environment at time of enrollment) 4. meet DSM-5 criteria for PTSD 5. provide informed consent and be willing to be randomized to PTSD treatment condition 6. agree to not receive non-study, active psychotherapy for PTSD during study treatment EXCLUSION CRITERIA: 1. Severe cognitive impairment 2. Current suicidal or homicidal intent with a specific plan 3. Unstable psychotic or manic symptoms not attributable to SUD 4. More than 30 days between index outpatient SUD intake/treatment planning appointment \& consent or more than 90 days between the index outpatient SUD visit and the first PTSD psychotherapy session
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT04581434
Study Brief:
Protocol Section: NCT04581434