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Идёт набор NCT07202351

Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy

Без фазы С лечением Sleep 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: Screening and management of sleep disorders.
Кому может быть актуально
Состояния в реестре: Sleep 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

Impact of an Intervention Targeting Sleep Disorders During Tobacco or Cannabis Cessation Therapy: a Randomised Pilot Study

Обзор

During a cessation therapy for tobacco or cannabis, sleep disorders are one of the main risk factors of relapse, and a symptom of substance withdrawing. In this study, we make the hypothesis that identifying and managing potential sleep disorders during cessation treatment may contribute to maintain tobacco / cannabis abstinence on the long-term. To evaluate the impact of such intervention, we will conduct a randomised pilot study among patients consulting at two addiction prevention and care centres, for smoking or cannabis use cessation treatment. Control group will benefit of usual care (a multidisciplinary care with individual and group therapies); intervention group will benefit in addition of a systematic screening of sleep disorders, and in case of a diagnosed alteration, they will be addressed to the Chronos centre, for specific care to help them manage and reduce the consequences of their sleep disorders. Participants will be followed over a 6-month period, with visits at 1 and 3 months, to monitor smoking or cannabis cessation, and other criteria associated with their substance use or sleep.

Подробное описание

Smoking is a serious public health issue in France, with one quarter of the population who smokes on a daily base. Tobacco use represents the first avoidable death cause. Cannabis, often use with tobacco, is the most frequent drug use, worldwide and with a prevalence of 3.2% of regular users in France, including 2.1% of daily users. Both substances are associated with sleep disorders; for instance, nicotine has several side effects, such as a negative impact on sleep quality and structure. During cessation therapy, sleep disorders were identified as a risk factor of relapse and one of the main lasting symptoms. Therefore, relation between addiction and sleep disorders seem to be bidirectional, potentially increasing the impact of each other. Screening and managing sleep disorders as a preventive measure to avoid relapse represents an improvement during smoking or cannabis use cessation treatment.

The main objective of the study is to evaluate the impact of a specific intervention targeting sleep disorders during tobacco or cannabis cessation therapy. We will conduct a randomised pilot study among patients presenting at two participating addiction prevention and care centres, for smoking or cannabis use cessation treatment. Patients who are eligible and agree to participate will be randomised in either control group, and will benefit of the usual care, or intervention group, and will benefit in addition of a systematic and standardised screening of sleep disorders, and specific care at the Chronos centre, if any disorder is diagnosed.

Patients will be followed over a 6-month period, with two visits at 1 and 3 months, to monitor indicators related to substance consumption and sleep. The impact of the targeted intervention will be evaluate based on the abstinence duration over the 6 months, calculated on the total number of days without tobacco / cannabis use. We will also collect other information that can be associated with the success or failure of cessation therapy, such as depressive symptoms, anxiety disorders, the use of other psychoactive substances (alcohol for instance), other psychiatric disorder, etc.

Questions on sleep will be asked to patients in the control group, to assess comparability of both groups throughout the study. This pilot trial will allow us to determine the feasibility and efficacy of a targeted intervention on sleep disorders during smoking or cannabis use cessation therapy, in order to generalise such care in the usual practice.

Вмешательства

  • Другое Screening and management of sleep disorders
    Patients in the intervention group will undergo a systematic and standardised screening of sleep disorders. If any trouble is identified, a specific treatment plan is offered at the Chronos centre, including for instance, cognitive behavioural therapy for insomnia, or nightmares will be treated with Image Rehearsal Therapy (IRT).

Первичные конечные точки

  • Abstinence [Срок оценки: M6: 6 months after inclusion]
Вторичные конечные точки (9)
  • Relapse [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Abstinence number of days [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Consumption number of days [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Carbon monoxide [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Insomnia [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Sleep quality [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Sleepiness [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Medication [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
  • Anxiety and depression [Срок оценки: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]

Критерии участия

Критерии включения

  • patients over 18 years old
  • presenting at the participating addiction treatment centres for a smoking or cabannis use cessation therapy
  • who agree to participate to the study
  • affiliated to the French health insurance system

Критерии исключения

  • Patients hospitalised during the cessation therapy
  • Patients undergoing sleep disorders treatment
  • Patients participating to another study
  • Patients with psychotic disorders (according the DSM-5 classification)
  • Patients who do not want the additionnal intervention and care if randomised in the intervention group

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • GHU Paris Psychiatrie et Neurosciences — Paris

Идентификаторы

NCT: NCT07202351 · D22_EPI0029

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗