Smokeless Tobacco UsePhase 3NCT00392379
Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
A Phase 3 study testing Nicotine Lozenges in people with Smokeless Tobacco Use, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smokeless Tobacco Use
- What is being tested?
- Nicotine Lozenges
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- are at least 18 years of age;
- report smokeless tobacco (ST) as their primary tobacco of use;
- have used ST daily for the past 6 months;
- are in general good health (determined by medical history and screening physical examination);
- have been provided with, understand, and have signed the informed consent.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.
Read the detailed description
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment
- Conditions
- Smokeless Tobacco Use
- Being tested
- Nicotine Lozenges, Placebo lozenge
- Keywords
- Tobacco use disorder, Tobacco cessation
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine LozengesDrug
Also called Commit nicotine lozenge
Nicotine lozenges, 4 mg
Placebo lozengeDrug
Placebo lozenge
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 4 mg nicotine lozenges for 3 months Receives: Drug: Nicotine Lozenges |
| B | Placebo comparator | Placebo nicotine lozenges for 3 months Receives: Drug: Placebo lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Smokeless Tobacco Abstinence at 3 Months
Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
Measured: 3 months
Secondary outcomes (2)
Self-reported Point Prevalence All Tobacco Abstinence at 3 Months
Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.
Measured: 3 months
Prolonged Smokeless Tobacco Abstinence at 6 Months
Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).
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 posted26 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smokeless Tobacco UseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jon Ebbert, Mayo Clinic
- Investigators
- Jon O. Ebbert, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392379
- Sponsor's protocol ID
- 06-003091
- Other IDs
- R01CA121165
- Status last verified
- Apr 2013
- First submitted
- 24 Oct 2006
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
- ClinicalTrials.gov ID
- NCT00392379
- Acronym / sponsor ID
- 06-003091
- Conditions
- Smokeless Tobacco Use
- Keywords
- Tobacco use disorder, Tobacco cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Posted 30 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.
Detailed description
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment
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 |
|---|---|---|
| A | Experimental | Drug: Nicotine Lozenges4 mg nicotine lozenges for 3 months |
| B | Placebo comparator | Drug: Placebo lozengePlacebo nicotine lozenges for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are at least 18 years of age;
- report smokeless tobacco (ST) as their primary tobacco of use;
- have used ST daily for the past 6 months;
- are in general good health (determined by medical history and screening physical examination);
- have been provided with, understand, and have signed the informed consent.
Key exclusion criteria (0 listed)
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 LozengesAlso: Commit nicotine lozengeNicotine lozenges, 4 mg | Drug | A |
| Placebo lozengePlacebo lozenge | Drug | B |
Primary outcome
Prolonged Smokeless Tobacco Abstinence at 3 Months
Time frame: 3 months
Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
2 secondary outcomes
Self-reported Point Prevalence All Tobacco Abstinence at 3 Months
Time frame: 3 months
Prolonged Smokeless Tobacco Abstinence at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon O. Ebbert, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine Lozenges in people with Smokeless Tobacco Use, run by Mayo Clinic at 2 sites in United States.
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 5 inclusion and 0 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 24 Apr 2013. 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 United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 30 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prolonged Smokeless Tobacco Abstinence at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2013.