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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT06050304
Eligibility Criteria:
Inclusion Criteria:
* \> 18 years
* Have a current crack-cocaine use disorder defined as Severe Intensity Use Disorder (6 or more DSM5 criteria), AND preferential use of rapid administration route (intravenous or smoked)
* Self-identified male or female (n=10 males, n=10 females)
* Negative pregnancy test for females and use of effective contraception
* Be affiliated with a social security plan (or PUMA or CSS or AME)
* Sign an informed consent and commit to a 3-week follow-up in the study
* Have a weight greater than 40 kg
Exclusion Criteria:
* • Patient with a psychiatric disorder or symptoms that are not currently stabilized
* Patient who is a minor or under protective supervision (curatorship or guardianship)
* Patient in care at the request of a judicial authority (therapeutic injunction, classification with orientation)
* Pregnant or breastfeeding women
* Patients who do not speak French or English sufficiently
* Patients weighing less than 40 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06050304
Study Brief:
Protocol Section:
NCT06050304