GHU Paris Psychiatrie et Neurosciences
Paris, Île-de-France Region, 75014, France
Location status: Recruiting
Location contact
Anne PEROZZIELLO, PhD
CONTACT
NCT Number: NCT07202351
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, Île-de-France Region, 75014, France
Location status: Recruiting
Anne PEROZZIELLO, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier St Anne
Other
Impact of an Intervention Targeting Sleep Disorders During Tobacco or Cannabis Cessation Therapy: a Randomised Pilot Study
Acronym: ISAC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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