Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT07202351
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy
Sponsor:
Centre Hospitalier St Anne
Organization:
Study Overview
Official Title:
Impact of an Intervention Targeting Sleep Disorders During Tobacco or Cannabis Cessation Therapy: a Randomised Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISAC
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: