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

NCT06050304 | Recruiting

• 1 other identifier: 2022-A02072-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cocaine Use Disorder

Keywords

Crack-cocaine; Behavioral Sensitization

Outcome Measures

Primary Outcomes (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)

  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)

  3 Weeks

Secondary Outcomes (11)

• Earlier onset of M10(the time of day when the 10 hours of peak motor activity begins, a reflection of the "motor wake-up time).

  3 Weeks

• Shorter relative amplitude of motor activity (the relative difference between M10)

  3 Weeks

• Self-defined patients' expectations toward treatment measured in qualitative interviews

  3 Weeks

• Higher scores assessed with questionnaires that approximate BS

  3 weeks

• WURS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS

  3 weeks

Other Outcomes (1)

• A/G % in rs7568970 polymorphism of the LRP1B gene in patients with observed versus without observed BS

  3 weeks

Study Arms (1)

Crack-cocaine Use Disorder users

EXPERIMENTAL

Observation of behaviour in ecological conditions in patients with crack-cocaine dependence

Behavioral: Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter; Biological: 3 blood tests

Interventions

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

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).

Crack-cocaine Use Disorder users

3 blood tests BIOLOGICAL

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

Crack-cocaine Use Disorder users

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Crack-Cocaine Use Disorders patients, men and women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Centre 001_Hôpital Fernand Widal

Paris, 75010, France

RECRUITING

Hôpital Fernand Widal

Paris, F75010, France

RECRUITING

MeSH Terms

Interventions

Behavior Observation Techniques

Intervention Hierarchy (Ancestors)

Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities

Study Officials

• Florence VORSPAN

  Hôpital Fernand Widal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Vorspan, MD, PhD

CONTACT

01 40 05 44 17; Florence.vorspan@aphp.fr

Florence Vorspan, MD, PhD

CONTACT

0140054417; Florence.vorspan@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: September 22, 2023
• Study Start: March 4, 2025
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)