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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance-Related Disorders; Smoking Cessation
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Department of Addiction Medicine, Haukeland University Hospital
  • Stavanger, Norway, 4010
    • LAR Helse Stavanger HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen; Helse Stavanger HF; Helse Vest
• Investigators: Principal Investigator: Lars Thore Fadnes, PhD, Haukeland University Hospital

Publications and helpful links

General Publications

• Druckrey-Fiskaaen KT, Furulund E, Daltveit JT, Vold JH, Lid TG, Madebo T, Fadnes LT; ATLAS4LAR Study Group. Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR). Trials. 2022 Aug 17;23(1):663. doi: 10.1186/s13063-022-06560-x.

Helpful Links

• Project home page

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Smoking Cessation; Opioid-Related Disorders; Opiate Substitution Treatment; Tobacco Use Cessation Devices
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 155386/ REK-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No