Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening and management of sleep disorders.
- Who it may be relevant to
- Registry conditions: Sleep Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of an Intervention Targeting Sleep Disorders During Tobacco or Cannabis Cessation Therapy: a Randomised Pilot Study
Overview
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.
Detailed description
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.
Interventions
- Other 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).
Primary outcome measures
- Abstinence [Time frame: M6: 6 months after inclusion]
Secondary outcome measures (9)
- Relapse [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Abstinence number of days [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Consumption number of days [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Carbon monoxide [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Insomnia [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Sleep quality [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Sleepiness [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Medication [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
- Anxiety and depression [Time frame: M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- GHU Paris Psychiatrie et Neurosciences — Paris
Identifiers
NCT: NCT07202351 · D22_EPI0029