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

Haukeland University Hospital

Status: Active, not recruiting

Conditions: Substance-Related Disorders; Smoking Cessation

Treatments: Other: Screening for interest in smoking cessation; Drug: Nicotine gum; Behavioral: Smoking cessation counselling; Drug: Nicotine lozenge; Other: Screening for use of tobacco products; Drug: Nicotine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05290025

155386/ REK-B

Details and patient eligibility

About

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 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.

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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266 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Nicotine patch

Other: Screening for use of tobacco products

Behavioral: Smoking cessation counselling

Drug: Nicotine lozenge

Drug: Nicotine gum

Other: Screening for interest in smoking cessation

Intitial screening only

Other group

Description:

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.

Treatment:

Other: Screening for use of tobacco products

Other: Screening for interest in smoking cessation