RecruitingNot ApplicableNCT06050304

CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations

Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

20 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • \> 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 Criteria6

  • • 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

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Interventions

BEHAVIORALObservation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter

In the form of a small watch, which collects the level of motor activity throughout the day and night. Patients will be asked to indicate each moment of crack-cocaine use by pressing the button in the center of the watch. We want to know if certain uses lead to more behavioral problems (especially after periods of cessation).

BIOLOGICAL3 blood tests

We will try to identify biomarkers of BS: blood proteins, genetic markers passed on by your parents, or the expression of proteins in particular situations


Locations(2)

Centre 001_Hôpital Fernand Widal

Paris, France

Hôpital Fernand Widal

Paris, France

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NCT06050304


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