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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

> 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

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

  • 3 blood tests

    Biological/Vaccine

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Crack-cocaine Use Disorder usersExperimental treatment 2 interventions

Trial outcomes

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)

Time frame
3 Weeks

Secondary outcomes

1

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)

Time frame
3 Weeks
2

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

Time frame
3 Weeks
3

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

Expectations toward treatment measured in qualitative interviews

Time frame
3 Weeks
4

Higher scores assessed with questionnaires that approximate BS

Higher scores assessed with questionnaires that approximate BS

Time frame
3 weeks

Other outcomes

1

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

Time frame
3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator