Smoking CessationBAReNikotinNCT05290025
Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco
A study testing Nicotine patch, Nicotine gum and Nicotine lozenge in people with Smoking Cessation and Substance-Related Disorders, run by Haukeland University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Substance-Related Disorders
- What is being tested?
- Nicotine patch, Nicotine gum and Nicotine lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 2 sitesNorway
- Study dates
- 7 Apr 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergies or prior anaphylactic reactions to medication used
- Smoking less than three times a week
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Addiction Medicine, Haukeland University Hospital
Bergen, 5021
LAR Helse Stavanger HF
Stavanger, 4010
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Smoking Cessation, Substance-Related Disorders
- Being tested
- Nicotine patch, Nicotine gum, Nicotine lozenge, Smoking cessation counselling, Screening for use of tobacco products
- Keywords
- Tobacco Use Cessation Devices, Smoking Cessation, Opioid-Related Disorders, Opiate Substitution Treatment
- Medical subject headings
- Smoking Cessation, Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
> 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
Nicotine gumDrug
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
Nicotine lozengeDrug
Nicotine lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day
Smoking cessation counsellingBehavioural
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.
Screening for use of tobacco productsOther
At the initiation of the trial screening questions about cigarett use for the last day and week.
Screening for interest in smoking cessationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Screening for use of tobacco products; Other: Screening for interest in smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Smoking cessation verified by CO-levels below 6 at the end of the intervention
Measured: 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
Measured: Mid of the intervention period 16 weeks after initiation
Secondary outcomes (9)
impact on inflammation -CRP
Impact of smoking cessation/ reduction on inflammation measured with C-reactive protein in serum
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Mid of the intervention period 16 weeks after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start7 Apr 2022
- Primary completion31 Oct 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, Helse Vest, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Lars Thore Fadnes, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290025
- Sponsor's protocol ID
- 155386/ REK-B
- Acronym
- BAReNikotin
- Status last verified
- Jun 2024
- First submitted
- 31 Jan 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39937506Druckrey-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.
PubMed 38184633Druckrey-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.
PubMed 35978355
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05290025
- Acronym / sponsor ID
- BAReNikotin / 155386/ REK-B
- Conditions
- Smoking Cessation, Substance-Related Disorders
- Keywords
- Tobacco Use Cessation Devices, Smoking Cessation, Opioid-Related Disorders, Opiate Substitution Treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, Helse Vest, University of Bergen
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | 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 cessationPatients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy. |
| Intitial screening only | Other | Other: Screening for use of tobacco products, Other: Screening for interest in smoking cessationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Allergies or prior anaphylactic reactions to medication used
- Smoking less than three times a week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intervention |
| Nicotine gumNicotine 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 | Intervention |
| Nicotine lozengeNicotine lozenges will be available in 1 and 2 mg strengths. Patients may individually choose which strength to use. Maximum 12 lozenges per day | Drug | Intervention |
| Smoking cessation counsellingOnce 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. | Behavioural | Intervention |
| Screening for use of tobacco productsAt the initiation of the trial screening questions about cigarett use for the last day and week. | Other | Intervention, Intitial screening only |
| Screening for interest in smoking cessationAt 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 | Intervention, Intitial screening only |
Primary outcome
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
9 secondary outcomes
impact on inflammation -CRP
Time frame: Mid of the intervention period 16 weeks after initiation
impact on inflammation - leukocytes
Time frame: Mid of the intervention period 16 weeks after initiation
Number of cigarettes smoked
Time frame: Mid of the intervention period 16 weeks after initiation
CO-levels in exhaled air
Time frame: Mid of the intervention period 16 weeks after initiation
Psychological distress
Time frame: Mid of the intervention period 16 weeks after initiation
Fatigue Symptom Scale
Time frame: Mid of the intervention period 16 weeks after initiation
Physical functioning
Time frame: Mid of the intervention period 16 weeks after initiation
Health-related quality of life
Time frame: Mid of the intervention period 16 weeks after initiation
Health-related quality of life
Time frame: Mid of the intervention period 16 weeks after initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 39937506Druckrey-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.
- Derived from this study: PubMed 38184633Druckrey-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.
- Derived from this study: PubMed 35978355Druckrey-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.
- Project home pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Thore Fadnes, PhD principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch, Nicotine gum and Nicotine lozenge in people with Smoking Cessation and Substance-Related Disorders, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: Mid of the intervention period 16 weeks after initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290025, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.