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

NCT05290025 | Active Not Recruiting

• 1 other identifier: 155386/ REK-B
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation; Substance-Related Disorders

Keywords

Tobacco Use Cessation Devices; Smoking Cessation; Opioid-Related Disorders; Opiate Substitution Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• impact on inflammation -CRP

  Mid of the intervention period 16 weeks after initiation

• impact on inflammation - leukocytes

  Mid of the intervention period 16 weeks after initiation

• Number of cigarettes smoked

  Mid of the intervention period 16 weeks after initiation

• CO-levels in exhaled air

  Mid of the intervention period 16 weeks after initiation

• Psychological distress

  Mid of the intervention period 16 weeks after initiation

Study Arms (2)

Intervention

EXPERIMENTAL

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; 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

OTHER

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; Other: Screening for interest in smoking cessation

Interventions

Nicotine patch DRUG

\> 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

Intervention

Nicotine gum DRUG

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

Intervention

Nicotine lozenge DRUG

Nicotine lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day

Intervention

Smoking cessation counselling BEHAVIORAL

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.

Intervention

Screening for use of tobacco products OTHER

At the initiation of the trial screening questions about cigarett use for the last day and week.

Intervention; Intitial screening only

Screening for interest in smoking cessation OTHER

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.

Intervention; Intitial screening only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergies or prior anaphylactic reactions to medication used
• Smoking less than three times a week

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator
• Helse Vest: collaborator
• University of Bergen: collaborator

Study Sites (2)

Department of Addiction Medicine, Haukeland University Hospital

Bergen, 5021, Norway

Location

LAR Helse Stavanger HF

Stavanger, 4010, Norway

Location

Related Publications (3)

• Druckrey-Fiskaaen KT, Madebo T, Daltveit JT, Vold JH, Furulund E, Chalabianloo F, Gilje Lid T, Fadnes LT. Integrated Nicotine Replacement and Behavioral Support to Reduce Smoking in Opioid Agonist Therapy: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):406-414. doi: 10.1001/jamapsychiatry.2024.4801.

  PMID: 39937506 DERIVED

• Druckrey-Fiskaaen KT, Madebo T, Daltveit JT, Vold JH, Furulund E, Lid TG, Fadnes LT. Update of statistical analysis plan for: 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. 2024 Jan 6;25(1):29. doi: 10.1186/s13063-023-07894-w.

  PMID: 38184633 DERIVED

• 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.

  PMID: 35978355 DERIVED

Related Links

• Project home page

MeSH Terms

Conditions

Smoking Cessation; Substance-Related Disorders; Opioid-Related Disorders

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum; Mass Screening

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Lars Thore Fadnes, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 22, 2022
• Study Start: April 7, 2022
• Primary Completion: October 31, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)