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

• ClinicalTrials.gov Identifier: NCT05290025
• Recruitment Status: Active, not recruiting
• First Posted: March 22, 2022
• Last Update Posted: September 25, 2023
• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF; Helse Vest; University of Bergen
• Information provided by (Responsible Party): Haukeland University Hospital

Tracking Information

• First Submitted Date: January 31, 2022
• First Posted Date: March 22, 2022
• Last Update Posted Date: September 25, 2023
• Actual Study Start Date: April 7, 2022
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 11, 2022)

• Smoking cessation [ Time Frame: 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 [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
  at least 50% reduction in number of cigarettes smoked by week 16 of the intervention

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 11, 2022)

• impact on inflammation -CRP [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
  If primary outcomes are not reached the daily number of cigarettes smoked is recorded
• CO-levels in exhaled air [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
  If primary outcomes are not reached the CO levels in the exhaled air is recorded
• Psychological distress [ Time Frame: 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 [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
  Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3)
• Physical functioning [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
  Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period
• Health-related quality of life [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
  Changes in health-related quality of life will be assessed with EuroQoL EQ-5D-5L
• Health-related quality of life [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: Single (Outcomes Assessor)
Masking Description:

Even though complete blinding is regarded as difficult and infeasible, patients will be informed of the follow-up they will receive but not on other follow-up alternatives that are used or the exact hypotheses for the study. Outcomes assessor will be blinded.

Primary Purpose: Health Services Research

Condition

• 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
• 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.

Study Arms

• 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.
  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
• 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.
  Interventions:

  • Other: Screening for use of tobacco products
  • Other: Screening for interest in smoking cessation

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 11, 2022): 133
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT05290025
• Other Study ID Numbers: 155386/ REK-B
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Haukeland University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Haukeland University Hospital
• Original Study Sponsor: Same as current

Collaborators

• Helse Stavanger HF
• Helse Vest
• University of Bergen

Investigators

• Principal Investigator: Lars Thore Fadnes, PhD; Haukeland University Hospital

• PRS Account: Haukeland University Hospital
• Verification Date: September 2023