CRACK-TARGET 1: Observing behavioral sensitization and expectations in people with crack-cocaine dependence
Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment
This project will try to see whether repeated crack-cocaine use produces measurable increases in movement by having 20 adults with severe crack dependence wear an activity monitor for three weeks and provide three blood samples.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06050304 on ClinicalTrials.gov |
What this trial studies
This observational protocol will enroll 20 adults (10 male, 10 female) with severe crack-cocaine use disorder who primarily use rapid administration routes (smoking or injection) and are in care at Fernand Widal Hospital in Paris. Participants will wear an actimeter continuously for three weeks to record movement patterns in a real-world setting and will provide three blood samples to search for potential biomarkers linked to behavioral sensitization. The study links objective actimetry data to timing of substance use and clinical observations to characterize motor response changes after intermittent crack use. Findings are intended to document whether behavioral sensitization seen in preclinical work can be detected ecologically in humans and to guide future biomarker and intervention research.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe DSM-5 crack-cocaine use disorder who primarily smoke or inject crack, can speak French or English, can commit to continuous actimeter wear for three weeks and to three blood draws, and are receiving care at Fernand Widal Hospital.
Not a fit: Patients unlikely to benefit include pregnant or breastfeeding women, minors, people with unstable psychiatric symptoms, those under judicial supervision, people who do not speak French or English sufficiently, or those who cannot commit to the three-week monitoring.
Why it matters
Potential benefit: If successful, this could identify objective movement signatures and blood markers that help spot or monitor behavioral destabilization in people with crack dependence, enabling earlier or more targeted care.
How similar studies have performed: Behavioral sensitization is well described in animal models and suggested by preliminary human data from this group, but continuous ecological monitoring with actimetry and biomarker sampling in crack users is a novel approach that has not yet been proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 1 other locations
- Centre 001_Hôpital Fernand Widal — Paris, France (Recruiting)
- Hôpital Fernand Widal — Paris, France (Recruiting)
Study contacts
- Principal investigator: Florence VORSPAN — Hôpital Fernand Widal
- Study coordinator: Florence Vorspan, MD, PhD
- Email: Florence.vorspan@aphp.fr
- Phone: 01 40 05 44 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.