Cocaine Use Disorder Clinical Trial
— CRACK-TARGETOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Fernand Widal | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Self-defined patients' expectations toward treatment measured in qualitative interviews | Expectations toward treatment measured in qualitative interviews | 3 Weeks | |
Secondary | Higher scores assessed with questionnaires that approximate BS | Higher scores assessed with questionnaires that approximate BS | 3 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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