Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy

NCT07202351 | Recruiting

• 1 other identifier: D22_EPI0029
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

sleep disorder; tobacco; cannabis; addiction

Outcome Measures

Primary Outcomes (1)

• Abstinence

  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.

  M6: 6 months after inclusion

Secondary Outcomes (9)

• 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

Study Arms (2)

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.

Other: Screening and management of sleep disorders

Interventions

Screening and management of sleep disorders 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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Psychiatrie et Neurosciences

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

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Marijuana Abuse; Behavior, Addictive

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Anne PEROZZIELLO

CONTACT

01.80.52.67.54; a.perozziello@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor and Hospital practitioner

Model Details: Randomised pilot clinical trial

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: June 5, 2023
• Primary Completion: February 27, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

FR (1)