Smokeless Tobacco UsePhase 2/3NCT00939029
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
A Phase 2/3 study testing nicotine replacement therapy (nicotine patches) in people with Smokeless Tobacco Use, run by Mayo Clinic at 1 site in United States.
Trial summary
Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco Use
- What is being tested?
- nicotine replacement therapy (nicotine patches)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- Phase
- Phase 2/3
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- are at least 18 years of age and at most 55 years of age;
- report daily ST use for the past 12 months;
- identify ST as their primary tobacco product;
- use an average of ≥ 3 cans/pouches per week;
- 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
- are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- are currently pregnant or lactating;
- have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;
- have a history of arrhythmia or an abnormal tracing on the baseline EKG;
- have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;
- have a history of severe skin allergies or dermatoses;
Show all 10Show fewer
- have a history of intolerance to nicotine patches;
- have another member of their household already participating in this study;
- are taking a medication known to interact with nicotine (i.e., clozapine);
- are taking any prescription medication for depression or asthma
Trial locations and contacts
1 site in 1 country.
About this study
Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.
Read the detailed description
Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality.
A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.
- Conditions
- Smokeless Tobacco Use
- Being tested
- nicotine replacement therapy (nicotine patches), placebo NRT
- Keywords
- tobacco use, smokeless tobacco, chewing tobacco, snuff, nicotine replacement, tobacco dependence, tobacco cessation, tobacco abstinence
- Medical subject headings
- Tobacco Use, 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 replacement therapy (nicotine patches)Drug
2- 21 mg patches per day for 8 weeks
placebo NRTDrug
2 placebo patches (containing no active ingredient)per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks Receives: Drug: nicotine replacement therapy (nicotine patches) |
| placebo | Placebo comparator | 2 patches (containing non active ingredients) per day for 8 weeks Receives: Drug: placebo NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Treatment (Week 8) Point Prevalence Abstinence
7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml
Measured: weeks 8
Secondary outcomes (2)
Point-prevalence Abstinence at 3 Months
7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml
Measured: week 12
Point-prevalence Abstinence at 6 Months
7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2013
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Ebbert, Mayo Clinic
- Investigators
- Jon O Ebbert, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939029
- Sponsor's protocol ID
- 09-002581
- Other IDs
- CA140125, 09-001763
- Status last verified
- May 2014
- First submitted
- 10 Jul 2009
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ebbert JO, Croghan IT, Schroeder DR, Hurt RD. A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users. Nicotine Tob Res. 2013 Dec;15(12):2037-44. doi: 10.1093/ntr/ntt097. Epub 2013 Jul 19.
PubMed 23873976
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
- ClinicalTrials.gov ID
- NCT00939029
- Acronym / sponsor ID
- 09-002581
- Conditions
- Smokeless Tobacco Use
- Keywords
- tobacco use, smokeless tobacco, chewing tobacco, snuff, nicotine replacement, tobacco dependence, tobacco cessation, tobacco abstinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.
Detailed description
Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality.
A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.
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 therapy (nicotine patches)2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks |
| placebo | Placebo comparator | Drug: placebo NRT2 patches (containing non active ingredients) per day for 8 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- are at least 18 years of age and at most 55 years of age;
- report daily ST use for the past 12 months;
- identify ST as their primary tobacco product;
- use an average of ≥ 3 cans/pouches per week;
- are in general good health (determined by medical history and screening physical examination);
Key exclusion criteria (10 listed)
- are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- are currently pregnant or lactating;
- have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;
- have a history of arrhythmia or an abnormal tracing on the baseline EKG;
- have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;
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 therapy (nicotine patches)2- 21 mg patches per day for 8 weeks | Drug | Active |
| placebo NRT2 placebo patches (containing no active ingredient)per day for 8 weeks | Drug | placebo |
Primary outcome
End of Treatment (Week 8) Point Prevalence Abstinence
Time frame: weeks 8
7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml
2 secondary outcomes
Point-prevalence Abstinence at 3 Months
Time frame: week 12
Point-prevalence Abstinence at 6 Months
Time frame: week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23873976Ebbert JO, Croghan IT, Schroeder DR, Hurt RD. A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users. Nicotine Tob Res. 2013 Dec;15(12):2037-44. doi: 10.1093/ntr/ntt097. Epub 2013 Jul 19.
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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 study chair
Mayo Clinic
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 nicotine replacement therapy (nicotine patches) in people with Smokeless Tobacco Use, run by Mayo Clinic at 1 site 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 10 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 19 May 2014. 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 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 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?
Yes. Results are posted in the registry (first posted 25 Apr 2014). 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?
End of Treatment (Week 8) Point Prevalence Abstinence (time frame: weeks 8). 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 NCT00939029, 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 19 May 2014.