Clinical trial NCT05290025: Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Substance-Related Disorders
Keywords: Tobacco Use Cessation Devices
Smoking Cessation
Opioid-Related Disorders
Opiate Substitution Treatment
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Helse Vest
name: University of Bergen
First posted: 2022-03-22
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomised to the intervention arm will receive an individually tailored plan for smoking cessation or reduction of number of cigarettes smoked. Smoking cessation treamtent consist of brief behavoiural interventions and provision of prescription-free nicotin patches, nicotine lozenges or nicotine gum.

Participants will collect the medication for smoking cessation once a week in parallel with delivery of OAT medication. Medication is individually packed for each patient and one week's use. Staff handing out the medication will give the patients a brief intervention asking about how they are progressing in their smoking cessation attempt, how much the patient smoked the day before and if they took the medication as planned. At mid of the intervention period around week 16 (12-20 weeks after intervention initiation), treatment effect measures will be collected
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking cessation
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Smoking reduction
timeFrame: Mid of the intervention period 16 weeks after initiation
Secondary outcomes:
measure: impact on inflammation -CRP
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: impact on inflammation - leukocytes
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Number of cigarettes smoked
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: CO-levels in exhaled air
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Psychological distress
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Fatigue Symptom Scale
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Physical functioning
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Health-related quality of life
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Health-related quality of life
timeFrame: Mid of the intervention period 16 weeks after initiation
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Addiction Medicine, Haukeland University Hospital
city: Stavanger
country: Norway
facility: LAR Helse Stavanger HF
Study officials:
affiliation: Haukeland University Hospital
name: Lars Thore Fadnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.