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

Smoking Cessation Clinical Trial

— BAReNikotin  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05290025
• Other study ID #: 155386/ REK-B
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 2026
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Substance-Related Disorders

Intervention

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
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Norway	Department of Addiction Medicine, Haukeland University Hospital	Bergen
Norway	LAR Helse Stavanger HF	Stavanger

Sponsors (4)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, Helse Vest, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation	Smoking cessation verified by CO-levels below 6 at the end of the intervention	Mid of the intervention period 16 weeks after initiation
Primary	Smoking reduction	at least 50% reduction in number of cigarettes smoked by week 16 of the intervention	Mid of the intervention period 16 weeks after initiation
Secondary	impact on inflammation -CRP	Impact of smoking cessation/ reduction on inflammation measured with C-reactive protein in serum	Mid of the intervention period 16 weeks after initiation
Secondary	impact on inflammation - leukocytes	Impact of smoking cessation/ reduction on inflammation measured with total leukocyte count in blood	Mid of the intervention period 16 weeks after initiation
Secondary	Number of cigarettes smoked	If primary outcomes are not reached the daily number of cigarettes smoked is recorded	Mid of the intervention period 16 weeks after initiation
Secondary	CO-levels in exhaled air	If primary outcomes are not reached the CO levels in the exhaled air is recorded	Mid of the intervention period 16 weeks after initiation
Secondary	Psychological distress	Changes in psychological well-being will be assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10)	Mid of the intervention period 16 weeks after initiation
Secondary	Fatigue Symptom Scale	Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3)	Mid of the intervention period 16 weeks after initiation
Secondary	Physical functioning	Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period	Mid of the intervention period 16 weeks after initiation
Secondary	Health-related quality of life	Changes in health-related quality of life will be assessed with EuroQoL EQ-5D-5L	Mid of the intervention period 16 weeks after initiation
Secondary	Health-related quality of life	Changes in health-related quality of life will be assessed with self-reported question on happiness on a 0 to 10 scale	Mid of the intervention period 16 weeks after initiation

External Links

•   Project home page