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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05290025
Acronym
BAReNikotin
Enrollment
266
Registered
2022-03-22
Start date
2022-04-07
Completion date
2026-12-31
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Substance-Related Disorders

Keywords

Tobacco Use Cessation Devices, Smoking Cessation, Opioid-Related Disorders, Opiate Substitution Treatment

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.

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.

Interventions

DRUGNicotine 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

DRUGNicotine 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

DRUGNicotine 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

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.

OTHERScreening for use of tobacco products

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

OTHERScreening 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.

Sponsors

Helse Stavanger HF
CollaboratorOTHER_GOV
Helse Vest
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking cessationMid of the intervention period 16 weeks after initiationSmoking cessation verified by CO-levels below 6 at the end of the intervention
Smoking reductionMid of the intervention period 16 weeks after initiationat least 50% reduction in number of cigarettes smoked by week 16 of the intervention

Secondary

MeasureTime frameDescription
Number of cigarettes smokedMid of the intervention period 16 weeks after initiationIf primary outcomes are not reached the daily number of cigarettes smoked is recorded
CO-levels in exhaled airMid of the intervention period 16 weeks after initiationIf primary outcomes are not reached the CO levels in the exhaled air is recorded
Psychological distressMid of the intervention period 16 weeks after initiationChanges in psychological well-being will be assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10)
impact on inflammation -CRPMid of the intervention period 16 weeks after initiationImpact of smoking cessation/ reduction on inflammation measured with C-reactive protein in serum
Physical functioningMid of the intervention period 16 weeks after initiationPhysical functioning assessed with 4-minute step-test measuring number of steps climbed in period
Health-related quality of lifeMid of the intervention period 16 weeks after initiationChanges in health-related quality of life will be assessed with EuroQoL EQ-5D-5L
Fatigue Symptom ScaleMid of the intervention period 16 weeks after initiationChanges in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3)
impact on inflammation - leukocytesMid of the intervention period 16 weeks after initiationImpact of smoking cessation/ reduction on inflammation measured with total leukocyte count in blood

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026