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 volunteersQualifiers
> 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
Single group
Treatments tested in this trial
Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter
BehavioralIn 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/VaccineWe 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
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
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
Self-defined patients' expectations toward treatment measured in qualitative interviews
Expectations toward treatment measured in qualitative interviews
Higher scores assessed with questionnaires that approximate BS
Higher scores assessed with questionnaires that approximate BS
Other outcomes
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
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator