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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Smoking Cessation Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Even though complete blinding is regarded as difficult and infeasible, patients will be informed of the follow-up they will receive but not on other follow-up alternatives that are used or the exact hypotheses for the study. Outcomes assessor will be blinded.

Study Groups

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Intervention

Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

\> 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

Nicotine gum

Intervention Type DRUG

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

Nicotine lozenge

Intervention Type DRUG

Nicotine lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day

Smoking cessation counselling

Intervention Type BEHAVIORAL

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.

Screening for use of tobacco products

Intervention Type OTHER

At the initiation of the trial screening questions about cigarett use for the last day and week.

Screening for interest in smoking cessation

Intervention Type OTHER

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.

Intitial screening only

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.

Group Type OTHER

Screening for use of tobacco products

Intervention Type OTHER

At the initiation of the trial screening questions about cigarett use for the last day and week.

Screening for interest in smoking cessation

Intervention Type OTHER

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.

Interventions

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Nicotine patch

\> 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

Intervention Type DRUG

Nicotine gum

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

Intervention Type DRUG

Nicotine lozenge

Nicotine lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day

Intervention Type DRUG

Smoking cessation counselling

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.

Intervention Type BEHAVIORAL

Screening for use of tobacco products

At the initiation of the trial screening questions about cigarett use for the last day and week.

Intervention Type OTHER

Screening for interest in smoking cessation

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.

Intervention Type OTHER

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