CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations (NCT06050304) | Clinical Trial Compass
RecruitingNot Applicable
CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations
France20 participantsStarted 2025-03-04
Plain-language summary
This research focuses on behavioral sensitization (BS) a specific behavioural disturbance in crack-cocaine addiction. The primary objective is to observe whether BS can be demonstrated in an ecological setting in crack dependent users by continuous actimetry for 3 weeks.
It is planned to include 20 persons with a current crack-cocaine addiction with a preferential use of rapid administration route (intravenous or smoke), in a care institution: Fernand Widal Hospital.
In the proposed research, the investigators will assess the movements of crack-cocaine dependent users in relation to consumption. They will have to wear continuously for 3 weeks an actimeter. They will also have 3 blood tests trying to identify biomarkers of BS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in sleep duration(hours/minutes) on crack-cocaine use days following a break of at least 2 days compared to crack-cocaine use days without any break (means over the 3 weeks period)