Smokeless Tobacco UsePhase 2NCT00888459
A Pilot Study Evaluating Nicotine Lozenges and Self Help
A Phase 2 study testing nicotine replacement therapy in people with Smokeless Tobacco Use, run by Mayo Clinic at 2 sites in United States.
Trial summary
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco Use
- What is being tested?
- nicotine replacement therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to May 2009
- Phase
- Phase 2
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male;
- ≥18 years of age;
- report ST as their primary tobacco of use;
- have used ST daily for the past 6 months;
- indicate that they want to quit;
- have been provided with, understand, and have signed the informed consent.
Who cannot join
- previously enrolled in a study involving the use of the nicotine lozenge;
- currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- currently enrolled in another research study;
- describe having a medical history of: a) unstable angina; b) myocardial infarction within the past 6 months; c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
- have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
- have another member of their household already participating in this study;
- have other medical or psychiatric conditions that would exclude the participant;
- have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
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: A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Read the detailed description
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.
- Conditions
- Smokeless Tobacco Use
- Being tested
- nicotine replacement therapy, placebo NRT
- Keywords
- tobacco, chew, nrt, nicotine lozenges, self-help
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine replacement therapyDrug
Also called Nicotine Lozenges
4 mg nicotine lozenges, ad lib, for 12 weeks.
placebo NRTDrug
Also called placebo
Placebo nicotine lozenges
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | Self-help counseling material and 4 mg nicotine lozenges Receives: Drug: nicotine replacement therapy |
| 2 | Placebo comparator | self help counseling material and placebo nicotine lozenges Receives: Drug: placebo NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tobacco Abstinence
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Research Institute
- Investigators
- Jon O Ebbert, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888459
- Sponsor's protocol ID
- 07-008574
- Other IDs
- CA121165
- Status last verified
- Oct 2023
- First submitted
- 24 Apr 2009
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 Jan 4.
PubMed 20060229
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
- ClinicalTrials.gov ID
- NCT00888459
- Acronym / sponsor ID
- 07-008574
- Conditions
- Smokeless Tobacco Use
- Keywords
- tobacco, chew, nrt, nicotine lozenges, self-help
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Oregon Research Institute
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Posted 4 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Detailed description
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.
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 |
|---|---|---|
| active | Active comparator | Drug: nicotine replacement therapySelf-help counseling material and 4 mg nicotine lozenges |
| 2 | Placebo comparator | Drug: placebo NRTself help counseling material and placebo nicotine lozenges |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male;
- ≥18 years of age;
- report ST as their primary tobacco of use;
- have used ST daily for the past 6 months;
- indicate that they want to quit;
Key exclusion criteria (8 listed)
- previously enrolled in a study involving the use of the nicotine lozenge;
- currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- currently enrolled in another research study;
- describe having a medical history of: a) unstable angina; b) myocardial infarction within the past 6 months; c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
- have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
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 replacement therapyAlso: Nicotine Lozenges4 mg nicotine lozenges, ad lib, for 12 weeks. | Drug | active |
| placebo NRTAlso: placeboPlacebo nicotine lozenges | Drug | 2 |
Primary outcome
Number of Participants With Tobacco Abstinence
Time frame: 12 weeks
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20060229Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 Jan 4.
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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, MD 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 2 study testing nicotine replacement therapy 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 6 inclusion and 8 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 23 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Nov 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?
Number of Participants With Tobacco Abstinence (time frame: 12 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 NCT00888459, which also lists 1 linked publication.
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 23 Oct 2023.