Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integration of Smoking Cessation Into Standard Treatment for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco: Protocol for a Randomised Controlled Trial

Conditions
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Smoking Cessation, Substance-Related Disorders

Intervention / Treatment
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* Drug: Nicotine patch
* Drug: Nicotine gum
* Drug: Nicotine lozenge
* Behavioral: Smoking cessation counselling
* Other: Screening for use of tobacco products
* Other: Screening for interest in smoking cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving OAT from an included outpatient clinic with weekly follow-up Smoking at least one cigarette per day or seven cigarettes per week Obtaining informed consent Exclusion Criteria: Allergies or prior anaphylactic reactions to medication used Smoking less than three times a week

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomised to the intervention arm will receive an individually tailored plan for smoking cessation or reduction of number of cigarettes smoked. Smoking cessation treamtent consist of brief behavoiural interventions and provision of prescription-free nicotin patches, nicotine lozenges or nicotine gum. Participants will collect the medication for smoking cessation once a week in parallel with delivery of OAT medication. Medication is individually packed for each patient and one week's use. Staff handing out the medication will give the patients a brief intervention asking about how they are progressing in their smoking cessation attempt, how much the patient smoked the day before and if they took the medication as planned. At mid of the intervention period around week 16 (12-20 weeks after intervention initiation), treatment effect measures will be collected
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy. | Drug: Nicotine patch<br>* > 20 cigarettes per day: 21 mg nicotine/ 24 hours 10-20 cigarettes per day: 14 mg nicotine/ 24 hours 5-10 cigarettes per day: 7 mg nicotine/ 24 hours<br>Drug: Nicotine gum<br>* Nicotine chewing gum will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 chewing gums per day<br>Drug: Nicotine lozenge<br>* Nicotine lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day<br>Behavioral: Smoking cessation counselling<br>* Once a week patients are asked about progress in cessation attempt. Sigaretts smoked the last week are recorded. Goal is set for the next week. Information on typical nicotine withdrawal symptoms and ameliorating techniques.<br>Other: Screening for use of tobacco products<br>* At the initiation of the trial screening questions about cigarett use for the last day and week.<br>Other: Screening for interest in smoking cessation<br>* At the initiation of the trial all smoking participants are asked if the are interested in changing their smoking habits. They are given three alternatives: will make cessation attempt; will make reduction attempt; not certain.<br>|
| Other: Intitial screening only<br>Participants will receive standard opioid replacement therapy. At the start of the intervention number of cigarettes smoked during the past week will be recorded. Smokers will be adviced to make a cessation or reduction attempt. Advice that nicotine replacement products ( patches, lozenges or gum) may be bought over the counter in grocery-stores and pharmacies and information about goverment home-pages giving cessation advice. | Other: Screening for use of tobacco products<br>* At the initiation of the trial screening questions about cigarett use for the last day and week.<br>Other: Screening for interest in smoking cessation<br>* At the initiation of the trial all smoking participants are asked if the are interested in changing their smoking habits. They are given three alternatives: will make cessation attempt; will make reduction attempt; not certain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation | Smoking cessation verified by CO-levels below 6 at the end of the intervention | Mid of the intervention period 16 weeks after initiation | 
| Smoking reduction | at least 50% reduction in number of cigarettes smoked by week 16 of the intervention | Mid of the intervention period 16 weeks after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact on inflammation -CRP | Impact of smoking cessation/ reduction on inflammation measured with C-reactive protein in serum | Mid of the intervention period 16 weeks after initiation | 
| impact on inflammation - leukocytes | Impact of smoking cessation/ reduction on inflammation measured with total leukocyte count in blood | Mid of the intervention period 16 weeks after initiation | 
| Number of cigarettes smoked | If primary outcomes are not reached the daily number of cigarettes smoked is recorded | Mid of the intervention period 16 weeks after initiation | 
| CO-levels in exhaled air | If primary outcomes are not reached the CO levels in the exhaled air is recorded | Mid of the intervention period 16 weeks after initiation | 
| Psychological distress | Changes in psychological well-being will be assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10) | Mid of the intervention period 16 weeks after initiation | 
| Fatigue Symptom Scale | Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3) | Mid of the intervention period 16 weeks after initiation | 
| Physical functioning | Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period | Mid of the intervention period 16 weeks after initiation | 
| Health-related quality of life | Changes in health-related quality of life will be assessed with EuroQoL EQ-5D-5L | Mid of the intervention period 16 weeks after initiation | 
| Health-related quality of life | Changes in health-related quality of life will be assessed with self-reported question on happiness on a 0 to 10 scale | Mid of the intervention period 16 weeks after initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Use Cessation Devices, Smoking Cessation, Opioid-Related Disorders, Opiate Substitution Treatment