Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco (BAReNikotin)
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| ClinicalTrials.gov Identifier: NCT05290025 |
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Recruitment Status :
Active, not recruiting
First Posted : March 22, 2022
Last Update Posted : September 25, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Cessation Substance-Related Disorders | 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 | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 133 participants |
| 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 |
| 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 |
| Actual Study Start Date : | April 7, 2022 |
| Estimated Primary Completion Date : | October 2023 |
| Estimated Study Completion Date : | December 2026 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05290025
| Norway | |
| Department of Addiction Medicine, Haukeland University Hospital | |
| Bergen, Norway, 5021 | |
| LAR Helse Stavanger HF | |
| Stavanger, Norway, 4010 | |
| Principal Investigator: | Lars Thore Fadnes, PhD | Haukeland University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT05290025 |
| Other Study ID Numbers: |
155386/ REK-B |
| First Posted: | March 22, 2022 Key Record Dates |
| Last Update Posted: | September 25, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Tobacco Use Cessation Devices Smoking Cessation Opioid-Related Disorders Opiate Substitution Treatment |
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Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |