Smoking CessationPhase 4SUNICNCT00861276
Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit
A Phase 4 study testing Nasal Spray Nicotine Substitute (Experimental) and Nasal Spray Nicotine Substitute (ad libitum) in people with Smoking Cessation, run by University of Lausanne at 1 site in Switzerland.
Trial summary
Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nasal Spray Nicotine Substitute (Experimental) and Nasal Spray Nicotine Substitute (ad libitum)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2000to Dec 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model
Who cannot join
- History of myocardial infarction in the preceding 3 months
- Pregnancy or breast-feeding
- Use of any form of smokeless tobacco or other nicotine replacement therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ambulatory Care and Community Medicine
Lausanne, Canton of Vaud, 1011
About this study
Official title: Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.
Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.
- Conditions
- Smoking Cessation
- Being tested
- Nasal Spray Nicotine Substitute (Experimental), Nasal Spray Nicotine Substitute (ad libitum)
- Keywords
- Smoking Cessation, Nicotine, Administration and dosage, Randomized Controlled Trial
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Spray Nicotine Substitute (Experimental)Drug
Also called Nicorette(R) nasal spray
During the first month, subjects in the intervention group received instruction from the physician to use NNS regularly (at least 2 puffs/hour, for an average of 1 mg nicotine/hour when awake).
Nasal Spray Nicotine Substitute (ad libitum)Drug
Also called Nicorette(R) Nasal Spray
In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm instructed to use spray at least once an hour when awake. Receives: Drug: Nasal Spray Nicotine Substitute (Experimental) |
| 2 | Active comparator | Ad libitum: patients were instructed to use NNS when craving appears. Receives: Drug: Nasal Spray Nicotine Substitute (ad libitum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado).
Measured: first 3 weeks
Secondary outcomes (1)
self-reported continuous abstinence from smoking from the beginning of the substitution to the end of the 6th month of follow-up, validated by an expired-air carbon monoxide (CO) concentration of less than 10 parts per million (ppm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJun 2000
- Primary completionJul 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia
- Investigators
- Jean-Pierre Zellweger, MD, Study director, Department of Ambulatory Care and Community Medicine, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861276
- Sponsor's protocol ID
- Prot 29/99
- Acronym
- SUNIC
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2009
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PubMed 37335995Rey L, Vaucher P, Secretan F, Zellweger JP, Bodenmann P. Use of nicotine substitute prescribed at hourly plus ab libitum intake or ad libitum for heavy smokers willing to quit: a randomized controlled trial. Subst Abuse Treat Prev Policy. 2009 Jun 2;4:12. doi: 10.1186/1747-597X-4-12.
PubMed 19490626
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00861276
- Acronym / sponsor ID
- SUNIC / Prot 29/99
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Nicotine, Administration and dosage, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Pharmacia
- Study start
- Jun 2000
- Primary completion
- Jul 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 13 Mar 2009 (estimated)
- 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.
Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.
Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nasal Spray Nicotine Substitute (Experimental)Arm instructed to use spray at least once an hour when awake. |
| 2 | Active comparator | Drug: Nasal Spray Nicotine Substitute (ad libitum)Ad libitum: patients were instructed to use NNS when craving appears. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model
Key exclusion criteria (3 listed)
- History of myocardial infarction in the preceding 3 months
- Pregnancy or breast-feeding
- Use of any form of smokeless tobacco or other nicotine replacement therapy
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 |
|---|---|---|
| Nasal Spray Nicotine Substitute (Experimental)Also: Nicorette(R) nasal sprayDuring the first month, subjects in the intervention group received instruction from the physician to use NNS regularly (at least 2 puffs/hour, for an average of 1 mg nicotine/hour when awake). | Drug | 1 |
| Nasal Spray Nicotine Substitute (ad libitum)Also: Nicorette(R) Nasal SprayIn the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared. | Drug | 2 |
Primary outcome
The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado).
Time frame: first 3 weeks
1 secondary outcome
self-reported continuous abstinence from smoking from the beginning of the substitution to the end of the 6th month of follow-up, validated by an expired-air carbon monoxide (CO) concentration of less than 10 parts per million (ppm)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2009.
- Derived from this study: PubMed 37335995Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
- Derived from this study: PubMed 19490626Rey L, Vaucher P, Secretan F, Zellweger JP, Bodenmann P. Use of nicotine substitute prescribed at hourly plus ab libitum intake or ad libitum for heavy smokers willing to quit: a randomized controlled trial. Subst Abuse Treat Prev Policy. 2009 Jun 2;4:12. doi: 10.1186/1747-597X-4-12.
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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.
Jean-Pierre Zellweger, MD study director
Department of Ambulatory Care and Community Medicine, University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nasal Spray Nicotine Substitute (Experimental) and Nasal Spray Nicotine Substitute (ad libitum) in people with Smoking Cessation, run by University of Lausanne at 1 site in Switzerland.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (time frame: first 3 weeks). 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 NCT00861276, which also lists 2 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 13 Mar 2009.