Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy
ConditionSleep Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Screening and management of sleep disorders
Other interventionPatients 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).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ContrôleNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
M6: 6 months after inclusionSecondary outcomes
1
Relapse
Relapse rate. Relapse is defined as ≥ 7 consecutive days of smoking tobacco or cannabis. Relapse will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.
Time frame
M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion2
Abstinence number of days
Longest period (number of consecutive days) without substance use, which will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.
Time frame
M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion3
Consumption number of days
Longest period (number of consecutive days) with substance use, which will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.
Time frame
M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion4
Carbon monoxide
Exhaled carbon monoxide test to monitor CO to assess objectively smoking level
Time frame
M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusionSponsors and contacts
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Source ClinicalTrials.gov