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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2023

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

  • Drug: 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
  • 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
  • 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
  • Behavioral: 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.
  • Other: Screening for use of tobacco products
    • At the initiation of the trial screening questions about cigarett use for the last day and week.
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Haukeland University Hospital
  • Collaborator
    • Helse Stavanger HF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lars Thore Fadnes, PhD, Principal Investigator, Haukeland University Hospital

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