Tobacco Use DisorderPhase 2NCT00218296
Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
A Phase 2 study testing Reduction Group in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Reduction Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jan 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No interest in stopping ST use within 90 days of study entry
- Daily use of ST in the 6 months prior to study entry
Who cannot join
- Current use of tobacco or nicotine products, other than ST
- Current unstable medical and mental health conditions
- Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Treatment of Smokeless Tobacco Users
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.
Read the detailed description
Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.
This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.
- Conditions
- Tobacco Use Disorder
- Being tested
- Usual Care Group, Reduction Group
- Keywords
- Nicotine Dependence, Tobacco Dependence
- 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.
Usual Care GroupDrug
Also called 21 mg Nicotine Patch, Nicoderm
Nicotine replacement therapy
Reduction GroupOther
Also called Commit Nicotine Lozenge or, Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)
Subject selects preferred method for reduction.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied. Receives: Drug: Usual Care Group |
| Reduction Group | Experimental | Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco. Receives: Other: Reduction Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)
No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)
Measured: 12 weeks
Percent Prolonged Abstinence From Tobacco at Week 12
Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)
Measured: 12 weeks
Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)
Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)
Measured: 26 week
Percent Prolonged Abstinence From Tobacco at Week 26
Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
Measured: 26 weeks
Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)
Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).
Measured: 32 Weeks
Percent Prolonged Abstinence From Tobacco at Week 32
Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
Measured: 32 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2006
- Primary completionJan 2009
- Study completionJan 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 Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218296
- Sponsor's protocol ID
- NIDA-14404-4
- Other IDs
- R01-DA14404-4, DPMCDA, R01DA014404
- Status last verified
- Sep 2017
- First submitted
- 16 Sep 2005
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res. 2012 Aug;14(8):902-9. doi: 10.1093/ntr/ntr302. Epub 2012 Jan 4.
PubMed 22218402
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Smokeless Tobacco Users
- ClinicalTrials.gov ID
- NCT00218296
- Acronym / sponsor ID
- NIDA-14404-4
- Conditions
- Tobacco Use Disorder
- Keywords
- Nicotine Dependence, Tobacco Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 19 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.
Detailed description
Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.
This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Drug: Usual Care GroupUsual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied. |
| Reduction Group | Experimental | Other: Reduction GroupReduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No interest in stopping ST use within 90 days of study entry
- Daily use of ST in the 6 months prior to study entry
Key exclusion criteria (4 listed)
- Current use of tobacco or nicotine products, other than ST
- Current unstable medical and mental health conditions
- Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
- Pregnant or breastfeeding
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 |
|---|---|---|
| Usual Care GroupAlso: 21 mg Nicotine Patch, NicodermNicotine replacement therapy | Drug | Usual Care Group |
| Reduction GroupAlso: Commit Nicotine Lozenge or, Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)Subject selects preferred method for reduction. | Other | Reduction Group |
Primary outcome
Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)
Time frame: 12 weeks
No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)
Percent Prolonged Abstinence From Tobacco at Week 12
Time frame: 12 weeks
Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)
Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)
Time frame: 26 week
Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)
Percent Prolonged Abstinence From Tobacco at Week 26
Time frame: 26 weeks
Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)
Time frame: 32 Weeks
Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).
Percent Prolonged Abstinence From Tobacco at Week 32
Time frame: 32 Weeks
Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22218402Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res. 2012 Aug;14(8):902-9. doi: 10.1093/ntr/ntr302. Epub 2012 Jan 4.
- Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res 2012.Link provided by the sponsor.
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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.
Dorothy Hatsukami, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reduction Group in people with Tobacco Use Disorder, run by University of Minnesota 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 2 inclusion and 4 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 16 Oct 2017. 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. 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 19 Dec 2013). 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?
Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 NCT00218296, 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 16 Oct 2017.