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临床试验/NCT07202351
NCT07202351招募中不适用

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

Centre Hospitalier St Anne1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Abstinence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Contrôle

No Intervention

In the control group, patients benefit from care as usual in one of the two addiction prevention and care clinics.

Intervention

Experimental

In the intervention group, patients will be benefit, in addition to the usual care of the smoking / tobacco cessation therapy, from a specific intervention to screen and care for sleep disorders, at the Chronos centre.

干预措施: Screening and management of sleep disorders (Other)

结局指标

主要结局

Abstinence

时间窗: M6: 6 months after inclusion

Abstinence to the substance (tobacco or cannabis, or both) defined by the absence of use of tobacco / cannabis products over the 6 month period after inclusion. Abstinence will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.

次要结局

  • Relapse(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Abstinence number of days(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Consumption number of days(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Carbon monoxide(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Insomnia(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Sleep quality(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Sleepiness(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Medication(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)
  • Anxiety and depression(M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion)

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Alexis GEOFFROY

University professor and Hospital practitioner

Centre Hospitalier St Anne

研究点 (1)

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