CRACK-TARGET 1: Observing behavioral sensitization and expectations in people with crack-cocaine dependence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.