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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Abstinence number of days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne PEROZZIELLO | Contact | 01.80.52.67.54 | a.perozziello@ghu-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHU Paris Psychiatrie et Neurosciences | Recruiting | Paris | ÃŽle-de-France Region | 75014 | France |
Data will be provided upon reasonable request addressed to the investigators.
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D002189 | Marijuana Abuse |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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Randomised pilot clinical trial
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|
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. |
| M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| 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. | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Carbon monoxide | Exhaled carbon monoxide test to monitor CO to assess objectively smoking level | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Insomnia | The severity of insomnia will be measured with the Insomnia Severity Index (ISI). Total score ranges from 0-28. INterpretation of the score 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). Total score ranges form 0 (better) to 21 (worse) sleeping quality. | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Sleepiness | Sleepiness will be evaluated with the Epworth Sleepiness Scale, which ranges from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness and from 11 to 24 indicates excessive (abnormal) daytime sleepiness. | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Medication | Patients will be asked if they take any medication to help reduce their sleep disorders (hypnotics, melatonin, etc.). | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| Anxiety and depression | Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression scale (HADs). There are two scores for items in each subscale : anxiety score (HADS-A) and depression score (HADS-D). Total score ranging from 0-21 for each subscale. A higher score indicates higher distress. Usually, a cut-off score of 11 for the total HADS, and 8 for the HADS-D are used. | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |