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

Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter; Biological: 3 blood tests

Detailed Description

Paris region and the French west indies face a specific epidemic of crack-cocaine use, mostly by socially deprived subjects, highly visible in open drug scenes, with little access to the care system. Patients who suffer from crack-cocaine dependence experiment a high rate of medical and a high mortality rate, because this type of cocaine is a short-acting form, used through rapid route of administration (usually smoked or injected).

Nevertheless, despite important uncovered medical needs, they are not often included in clinical trials and there is to date no pharmacological treatment for this severe condition. The investigators identified behavioral disturbances as a key problem in crack-cocaine dependence, as it is the second cause for emergency visits for those patients and a reason to be excluded from addiction care facilities.

Based on preliminary results already gathered by our group, the investigators suggest that behavioral sensitization (BS), an increase of motor response to cocaine after repetitive intermittent use, could be assessed in Humans.

Our goal is therefore to include 20 persons (10 males - 10 females) with a current cocaine use disorder,specifically crack users, with preferential use of rapid administration route (intravenous or smoke), in a care institution: the Fernand Widal Hospital (Assistance Publique - Hôpitaux de Paris). 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, in the form of a small watch, which collects the level of motor activity throughout the day and night. They will be asked to indicate each moment of crack-cocaine use by pressing the button in the center of the watch. The investigators want to know if certain uses lead to more behavioral problems (especially after periods of cessation).

They will also have 3 blood tests: the investigators want to know if blood proteins, genetic markers passed on by paricipants parents or the expression of proteins in particular situations, could predict this increase in motor effects for small doses of crack-cocaine.

The investigators also want to better understand the needs of crack-cocaine dependent patients towards treatments and their expectations for recovery, by conducting a qualitative study where patients will participate in the definition of treatment aims to increase the efficiency of care

With the project CRACK-TARGET 1 : DETA, the investigators aim at demonstrating the existence of BS in patients with crack dependent subjects. Furthermore, the investigators aim at developing specific, repeatable, easy to access measure of BS using questionnaires and objective actigraphy biomarkers to be used as surrogate endpoints in clinical trials.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence Vorspan, MD, PhD; Phone Number: 01 40 05 44 17; Email: Florence.vorspan@aphp.fr
• Study Contact Backup: Name: Florence Vorspan, MD, PhD; Phone Number: 0140054417; Email: Florence.vorspan@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Centre 001_Hôpital Fernand Widal
  • Paris, France, F75010
    • Recruiting
    • Hôpital Fernand Widal
    • Contact: Nora Keltoumi; Phone Number: 33 1 40 05 44 17; Email: Nora.keltoumi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

10 Man 10 Woman

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Crack-cocaine Use Disorder users; 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; 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).; Biological: 3 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The time of day when the 10 hours of peak motor activity begins, a reflection of the "motor wake-up time") (hours/minutes) during crack-cocaine use days following a 2 days break compared to crack-cocaine use days without any break (comparison of mean M10 time)	3 Weeks
Shorter relative amplitude of motor activity (the relative difference between M10)	Average activity level during the most active 10-hour period) and L5 (average activity level during the least active 5-hour period) (hours/minutes) during crack-cocaine use days following a 2 days break compared to crack-cocaine use days without any break (comparison of mean relative amplitudes over 3 weeks	3 Weeks
Self-defined patients' expectations toward treatment measured in qualitative interviews	Expectations toward treatment measured in qualitative interviews	3 Weeks
Higher scores assessed with questionnaires that approximate BS	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	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
ASRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	ASRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	3 weeks
SAPS-CIP in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	SAPS-CIP in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	3 weeks
YMRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	YMRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	3 weeks
UPPS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	UPPS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	3 weeks
PDI in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	PDI in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	3 weeks
PANSS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS	PANSS 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A/G % in rs7568970 polymorphism of the LRP1B gene in patients with observed versus without observed BS	Fold change of the methylation status of the LRP1B gene in patients with observed versus without observed BS	3 weeks

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Florence VORSPAN, Hôpital Fernand Widal

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): March 4, 2026
• Study Completion (Estimated): March 4, 2026

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Crack-cocaine; Behavioral Sensitization
• Additional Relevant MeSH Terms: Investigative Techniques; Behavioral Disciplines and Activities; Psychological Techniques; Behavior Observation Techniques
• Other Study ID Numbers: 2022-A02072-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD can be available upon reasonable request made to the promotor (DRCI APHP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No