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Идёт набор NCT06050304

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

Без фазы С лечением Cocaine Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter, 3 blood tests.
Кому может быть актуально
Состояния в реестре: Cocaine Use Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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).
  • Биопрепарат 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

Первичные конечные точки

  • 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) [Срок оценки: 3 Weeks]
Вторичные конечные точки (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). [Срок оценки: 3 Weeks]
  • Shorter relative amplitude of motor activity (the relative difference between M10) [Срок оценки: 3 Weeks]
  • Self-defined patients' expectations toward treatment measured in qualitative interviews [Срок оценки: 3 Weeks]
  • Higher scores assessed with questionnaires that approximate BS [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

  • > 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

Критерии исключения

  • • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 2 центра
  • Centre 001_Hôpital Fernand Widal — Paris
  • Hôpital Fernand Widal — Paris

Идентификаторы

NCT: NCT06050304 · 2022-A02072-41

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗