Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy

NCT ID: NCT07202351

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2026-08-31

Brief 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.

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.

Conditions

Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Contrôle

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

Screening and management of sleep disorders

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Pierre Alexis GEOFFROY

University professor and Hospital practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GHU Paris Psychiatrie et Neurosciences

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Anne PEROZZIELLO

Role: CONTACT

a.perozziello@ghu-paris.fr

01.80.52.67.54

Facility Contacts

Anne PEROZZIELLO, PhD

Role: primary

Other Identifiers

D22_EPI0029

Identifier Type: -

Identifier Source: org_study_id