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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT05162651
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged between 18 and 55 years (from both sexes \[or genders\]);
2. Diagnosed with CUD (moderate or severe) according to the Structured Clinical Interview for DSM-IV (SCID) (mode of cannabis consumption can be inhalation or ingestion);
3. Diagnosis of current (past 30 days) PTSD, using the CAPS-5 on screening;
4. On antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as PTSD treatment of our population);
5. Be able to provide written informed consent; and
6. Be able to communicate in English.
Exclusion Criteria:
1. diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician;
2. diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on DSM-5 criteria;
3. current suicidality risk as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after the study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes" 34; and
4. have pain interfering with normal function as reported by the 12-Item Short Form Survey (SF-12) (moderate or higher interference).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05162651
Study Brief:
Protocol Section:
NCT05162651