Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05290025
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2022-01-31
Brief Title:
Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Integration of Smoking Cessation Into Standard Treatment for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco Protocol for a Randomised Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
BAReNikotin
Brief Summary:
Background About 85 of those receiving opioid agonist therapy OAT for opioid dependence are smoking tobacco Cigarette smoke lead to lunge diseases and cause illness and death within this group BAReNikotin is a multicentre randomised controlled clinical trial that will test if integration of smoking cessation therapy to clinical practice at OAT-clinics will increase the rate of OAT-patients that quit smoking
Intervention The patients selected for the intervention arm will receive smoking cessation therapy including weekly brief behavioural interventions and prescription-free nicotine replacement products such as nicotine lozenges patches and chewing gum for at least 16 weeks This will be compared to a group of patients who does not receive any help to quit smoking apart from intial screening of smoking behaviour and advice on where to buy nicotine replacement products
The patients will have to attend OAT outpatient clinics in Bergen and Stavanger Norway The main evaluation will take place 16 weeks after the start of the study
Study population The target group will be patients with severe opioid dependence receiving OAT from outpatient clinics in the aforementioned cities who are smoking tobacco daily
Expected outcome The primary goal of the study is to see how many of those patients that are offered smoking cessation treatment that have stopped smoking or reduced the number of cigarettes smoked by at least one half by the end of the intervention We will also investigate if quitting smoking changes the well-being physical fitness and quality of life of the participants If the nicotine replacement therapy is safe and efficacious it can be considered for further scale-up
Intervention The patients selected for the intervention arm will receive smoking cessation therapy including weekly brief behavioural interventions and prescription-free nicotine replacement products such as nicotine lozenges patches and chewing gum for at least 16 weeks This will be compared to a group of patients who does not receive any help to quit smoking apart from intial screening of smoking behaviour and advice on where to buy nicotine replacement products
The patients will have to attend OAT outpatient clinics in Bergen and Stavanger Norway The main evaluation will take place 16 weeks after the start of the study
Study population The target group will be patients with severe opioid dependence receiving OAT from outpatient clinics in the aforementioned cities who are smoking tobacco daily
Expected outcome The primary goal of the study is to see how many of those patients that are offered smoking cessation treatment that have stopped smoking or reduced the number of cigarettes smoked by at least one half by the end of the intervention We will also investigate if quitting smoking changes the well-being physical fitness and quality of life of the participants If the nicotine replacement therapy is safe and efficacious it can be considered for further scale-up
Detailed Description:
Background About 85 of those receiving opioid agonist therapy OAT for opioid dependence are smoking tobacco Smoke-related pulmonary diseases are significant contributors to morbidity and mortality within this group BAReNikotin is a multicentre randomised controlled clinical trial that will compare if integrated smoking cessation therapy increases the rate om smoking cessation compared to standard treatment at OAT-clinics among patients who receive OAT
Study design BAReNikotin is a multicentre randomised controlled clinical trial that will recruit 266 patients receiving OAT in Bergen and Stavanger Norway
Intervention The patients selected for the intervention arm will receive smoking cessation therapy including weekly brief behavioural interventions and prescription-free nicotine replacement products such as nicotine lozenges patches and chewing gum for at least 16 weeks This will be compared to a group of patients who does not receive any help to quit smoking apart from intial screening of smoking behaviour and advice on where to buy nicotine replacement products
Study population The target group will be patients with severe opioid dependence receiving OAT from outpatient clinics in the aforementioned cities who are smoking tobacco daily
Expected outcome The primary outcomes are smoking cessation verified by carbon monoxide CO-levels or at least a 50 reduction in the number of cigarettes smoked The study will assess changes in psychological well-being impact of smoking cessation and reduction on inflammation changes in physical health relative quality of life and fatigue If the integraded approach increases the number of successful cessation attempts this would be a strong argument for including smoking cessation therapy into regulart OAT-treatment
Study design BAReNikotin is a multicentre randomised controlled clinical trial that will recruit 266 patients receiving OAT in Bergen and Stavanger Norway
Intervention The patients selected for the intervention arm will receive smoking cessation therapy including weekly brief behavioural interventions and prescription-free nicotine replacement products such as nicotine lozenges patches and chewing gum for at least 16 weeks This will be compared to a group of patients who does not receive any help to quit smoking apart from intial screening of smoking behaviour and advice on where to buy nicotine replacement products
Study population The target group will be patients with severe opioid dependence receiving OAT from outpatient clinics in the aforementioned cities who are smoking tobacco daily
Expected outcome The primary outcomes are smoking cessation verified by carbon monoxide CO-levels or at least a 50 reduction in the number of cigarettes smoked The study will assess changes in psychological well-being impact of smoking cessation and reduction on inflammation changes in physical health relative quality of life and fatigue If the integraded approach increases the number of successful cessation attempts this would be a strong argument for including smoking cessation therapy into regulart OAT-treatment
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None