Sleep Disorder
Conditions
Keywords
sleep disorder, tobacco, cannabis, addiction
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.
Interventions
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).
Sponsors
Study design
Intervention model description
Randomised pilot clinical trial
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence number of days | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | 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. |
| Consumption number of days | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | 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. |
| Carbon monoxide | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | Exhaled carbon monoxide test to monitor CO to assess objectively smoking level |
| Insomnia | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | 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) |
| Relapse | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | 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. |
| Sleepiness | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | 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. |
| Medication | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | Patients will be asked if they take any medication to help reduce their sleep disorders (hypnotics, melatonin, etc.). |
| Anxiety and depression | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | 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. |
| Sleep quality | M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion | Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). Total score ranges form 0 (better) to 21 (worse) sleeping quality. |
Countries
France