Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy

Last updated: September 23, 2025
Sponsor: Centre Hospitalier St Anne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Restless Leg Syndrome

Insomnia

Treatment

Screening and management of sleep disorders

Clinical Study ID

NCT07202351
D22_EPI0029
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients over 18 years old

  • presenting at the participating addiction treatment centres for a smoking orcabannis use cessation therapy

  • who agree to participate to the study

  • affiliated to the French health insurance system

Exclusion

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 theintervention group

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Screening and management of sleep disorders
Phase:
Study Start date:
June 05, 2023
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • GHU Paris Psychiatrie et Neurosciences

    Paris 2988507, Île-de-France Region 3012874 75014
    France

    Active - Recruiting

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