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Recruiting Not applicable

Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy

NCT07202351 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-06-05
Last updated
2025-10-01

Condition(s) studied

Sleep Disorder

Investigational drug(s) / intervention(s)

Screening and management of sleep disorders

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).

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Abstinence — 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.

Trial sites (1)

FacilityCityRegionStatus
GHU Paris Psychiatrie et Neurosciences Paris Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202351 on ClinicalTrials.gov ↗ ← All trials in France