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

Not Applicable

Active, not recruiting

• Conditions: Smoking Cessation; Substance-Related Disorders
• Interventions: Drug: Nicotine patch; Drug: Nicotine gum; Drug: Nicotine lozenge; Behavioral: Smoking cessation counselling; Other: Screening for use of tobacco products; Other: Screening for interest in smoking cessation

• Registration Number: NCT05290025
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-22
• Study Start: 2022-04-07
• Primary Completion: 2023-10-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 266

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

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Exclusion Criteria

• Allergies or prior anaphylactic reactions to medication used
• Smoking less than three times a week

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Nicotine patch	Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.
Intervention	Screening for use of tobacco products	Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.
Intervention	Screening for interest in smoking cessation	Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.
Intitial screening only	Screening for use of tobacco products	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.
Intervention	Nicotine gum	Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.
Intervention	Smoking cessation counselling	Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.
Intitial screening only	Screening for interest in smoking cessation	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.
Intervention	Nicotine lozenge	Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.

Primary Outcome Measures

Name	Time	Method
Smoking cessation	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	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 Outcome Measures

Name	Time	Method
impact on inflammation -CRP	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	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	Mid of the intervention period 16 weeks after initiation	If primary outcomes are not reached the daily number of cigarettes smoked is recorded
Psychological distress	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	Mid of the intervention period 16 weeks after initiation	Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3)
Health-related quality of life	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
CO-levels in exhaled air	Mid of the intervention period 16 weeks after initiation	If primary outcomes are not reached the CO levels in the exhaled air is recorded
Physical functioning	Mid of the intervention period 16 weeks after initiation	Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period

Trial Locations

Locations (2)

LAR Helse Stavanger HF; 🇳🇴 Stavanger, Norway

Department of Addiction Medicine, Haukeland University Hospital; 🇳🇴 Bergen, Norway