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NCT Number: NCT05290025

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

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

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

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

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

Other

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

Screening for interest in smoking cessation

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.

Primary outcomes

  1. Smoking cessation

    Time frame: Mid of the intervention period 16 weeks after initiation

    Smoking cessation verified by CO-levels below 6 at the end of the intervention

  2. Smoking reduction

    Time frame: Mid of the intervention period 16 weeks after initiation

    at least 50% reduction in number of cigarettes smoked by week 16 of the intervention

Secondary outcomes

  1. impact on inflammation -CRP

    Time frame: Mid of the intervention period 16 weeks after initiation

    Impact of smoking cessation/ reduction on inflammation measured with C-reactive protein in serum

  2. impact on inflammation - leukocytes

    Time frame: Mid of the intervention period 16 weeks after initiation

    Impact of smoking cessation/ reduction on inflammation measured with total leukocyte count in blood

  3. Number of cigarettes smoked

    Time frame: Mid of the intervention period 16 weeks after initiation

    If primary outcomes are not reached the daily number of cigarettes smoked is recorded

  4. CO-levels in exhaled air

    Time frame: Mid of the intervention period 16 weeks after initiation

    If primary outcomes are not reached the CO levels in the exhaled air is recorded

  5. Psychological distress

    Time frame: Mid of the intervention period 16 weeks after initiation

    Changes in psychological well-being will be assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10)

  6. Fatigue Symptom Scale

    Time frame: Mid of the intervention period 16 weeks after initiation

    Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3)

  7. Physical functioning

    Time frame: Mid of the intervention period 16 weeks after initiation

    Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period

  8. Health-related quality of life

    Time frame: Mid of the intervention period 16 weeks after initiation

    Changes in health-related quality of life will be assessed with EuroQoL EQ-5D-5L

  9. Health-related quality of life

    Time frame: Mid of the intervention period 16 weeks after initiation

    Changes in health-related quality of life will be assessed with self-reported question on happiness on a 0 to 10 scale

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Stavanger HF
  • Helse Vest
  • University of Bergen

Registry information

Official study title

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

Acronym: BAReNikotin

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Mar 22, 2022
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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