Tobacco DependencePhase 2/3NCT00977249
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
A Phase 2/3 study testing support and visits and varenicline in people with Tobacco Dependence, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop? Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- support and visits and varenicline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 2/3
- 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
- Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
- More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
- more than 10 puffs of nasal spray per day.
Who cannot join
- Age < 18 years,
- CO Smokers,
- Pregnant and lactating women,
- Used varenicline before,
- Not able to cooperate,
- Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air > 7 ppm.
Trial locations and contacts
1 site in 1 country.
Helle Johnson, reg. nurse contact
Denmark1 site, 1 recruiting
- Recruiting
Gentofte Hospital
Copenhagen, Hellerup, 2900
Helle Johnson, reg Nures, +4539773512
Helle Johnson, reg.nures
About this study
Official title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?
Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.
Read the detailed description
100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.
Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.
- Conditions
- Tobacco Dependence
- Being tested
- support and visits, varenicline, placebo
- Keywords
- long term nicotine gum use, varenicline, adverse effects
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
support and visitsBehavioural
visits at weeks 0,2,4,6,9 and 12 and 12 months
vareniclineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Active comparator | Varenicline for 12 weeks.
The treatment schedule for varenicline is:
Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks Receives: Behavioral: support and visits; Drug: varenicline |
| placebo | Placebo comparator | Placebo for 12 weeks Receives: Behavioral: support and visits; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Measured: 12 weeks +/- 1 week
Secondary outcomes (1)
is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Measured: 12 months +/- 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Tobacco DependenceStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Philip Tønnesen, M.D., Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977249
- Sponsor's protocol ID
- EudraCTnumber 2008-006426-24
- Status last verified
- Sep 2009
- First submitted
- 14 Sep 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Tonnesen P, Mikkelsen K. Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Nicotine Tob Res. 2013 Feb;15(2):419-27. doi: 10.1093/ntr/nts146. Epub 2012 Sep 27.
PubMed 23024246
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00977249
- Acronym / sponsor ID
- EudraCTnumber 2008-006426-24
- Conditions
- Tobacco Dependence
- Keywords
- long term nicotine gum use, varenicline, adverse effects
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Sep 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.
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?
Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.
Detailed description
100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.
Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Active comparator | Behavioral: support and visits, Drug: vareniclineVarenicline for 12 weeks. The treatment schedule for varenicline is: Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks |
| placebo | Placebo comparator | Behavioral: support and visits, Drug: placeboPlacebo for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
- More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
- more than 10 puffs of nasal spray per day.
Key exclusion criteria (6 listed)
- Age < 18 years,
- CO Smokers,
- Pregnant and lactating women,
- Used varenicline before,
- Not able to cooperate,
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 |
|---|---|---|
| support and visitsvisits at weeks 0,2,4,6,9 and 12 and 12 months | Behavioural | placebo, varenicline |
| varenicline | Drug | varenicline |
| placebo | Drug | placebo |
Primary outcome
Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Time frame: 12 weeks +/- 1 week
1 secondary outcome
is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Time frame: 12 months +/- 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 23024246Tonnesen P, Mikkelsen K. Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Nicotine Tob Res. 2013 Feb;15(2):419-27. doi: 10.1093/ntr/nts146. Epub 2012 Sep 27.
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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.
Helle Johnson, reg. nurse contact
Philip Tønnesen, M.D. principal investigator
Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing support and visits and varenicline in people with Tobacco Dependence, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Sep 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Tønnesen, M.D: (+4539773508, philipt@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (time frame: 12 weeks +/- 1 week). 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 NCT00977249, 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 15 Sep 2009.