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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
266
\> 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 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 lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day
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.
At the initiation of the trial screening questions about cigarett use for the last day and week.
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.
Department of Addiction Medicine, Haukeland University Hospital
Bergen, Norway
LAR Helse Stavanger HF
Stavanger, Norway
Smoking cessation
Smoking cessation verified by CO-levels below 6 at the end of the intervention
Time frame: 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
Time frame: Mid of the intervention period 16 weeks after initiation
impact on inflammation -CRP
Impact of smoking cessation/ reduction on inflammation measured with C-reactive protein in serum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Mid of the intervention period 16 weeks after initiation
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