Tobacco Use DisorderPhase 1/2BrandswitchNCT00218244
Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
A Phase 1/2 study testing Lower Nicotine Smokeless Tobacco Product and Behavioral Counseling in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Lower Nicotine Smokeless Tobacco Product and Behavioral Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Nov 2004
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not interested in quitting ST use within 90 days of study entry
- Has been using ST at least six times a day for 6 months prior to study entry
- Agrees to use an effective form of contraception throughout the study
Who cannot join
- Current use of other tobacco or nicotine products
- Pregnant or breastfeeding
- Any unstable medical condition
- Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
- DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
- Use of any psychotropic medications within 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use
Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Read the detailed description
Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.
- Conditions
- Tobacco Use Disorder
- Being tested
- Lower Nicotine Smokeless Tobacco Product, Behavioral Counseling
- Keywords
- Brand Switching, smokeless tobacco use
- 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.
Lower Nicotine Smokeless Tobacco ProductOther
Also called Skoal and Skoal Bandits
Skoal for 50% reduction;Skoal bandits for 75% reduction.
Behavioral CounselingOther
Behavioral counseling alone for reduction in tobacco use.
| Study group | Role | What they receive |
|---|---|---|
| 1 Controlled use | Active comparator | Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition. Receives: Other: Lower Nicotine Smokeless Tobacco Product |
| 2 Uncontrolled use | Active comparator | Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition. Receives: Other: Lower Nicotine Smokeless Tobacco Product |
| 3 Behavioral | Placebo comparator | Reduction in smokeless tobacco use using behavioral techniques only. Receives: Other: Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in ST use
Measured: 26 weeks
Toxicity profile of carcinogen metabolites
Measured: 26 weeks
Number of unsuccessful quit attempts
Measured: 26 weeks
Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion)
Measured: 26 weeks
Secondary outcomes (1)
Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)
Measured: 26 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 startAug 2001
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dorothy Hatsukami, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218244
- Sponsor's protocol ID
- NIDA-14404-1
- Other IDs
- R01-14404-1, DPMC
- Acronym
- Brandswitch
- Status last verified
- Jun 2008
- First submitted
- 16 Sep 2005
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use
- ClinicalTrials.gov ID
- NCT00218244
- Acronym / sponsor ID
- Brandswitch / NIDA-14404-1
- Conditions
- Tobacco Use Disorder
- Keywords
- Brand Switching, smokeless tobacco use
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2001
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 22 Sep 2005 (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.
Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Detailed description
Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Controlled use | Active comparator | Other: Lower Nicotine Smokeless Tobacco ProductReduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition. |
| 2 Uncontrolled use | Active comparator | Other: Lower Nicotine Smokeless Tobacco ProductReduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition. |
| 3 Behavioral | Placebo comparator | Other: Behavioral CounselingReduction in smokeless tobacco use using behavioral techniques only. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not interested in quitting ST use within 90 days of study entry
- Has been using ST at least six times a day for 6 months prior to study entry
- Agrees to use an effective form of contraception throughout the study
Key exclusion criteria (6 listed)
- Current use of other tobacco or nicotine products
- Pregnant or breastfeeding
- Any unstable medical condition
- Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
- DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
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 |
|---|---|---|
| Lower Nicotine Smokeless Tobacco ProductAlso: Skoal and Skoal BanditsSkoal for 50% reduction;Skoal bandits for 75% reduction. | Other | 1 Controlled use, 2 Uncontrolled use |
| Behavioral CounselingBehavioral counseling alone for reduction in tobacco use. | Other | 3 Behavioral |
Primary outcome
Percent reduction in ST use
Time frame: 26 weeks
Toxicity profile of carcinogen metabolites
Time frame: 26 weeks
Number of unsuccessful quit attempts
Time frame: 26 weeks
Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion)
Time frame: 26 weeks
1 secondary outcome
Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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 1/2 study testing Lower Nicotine Smokeless Tobacco Product and Behavioral Counseling in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) 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 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: finished, as of the sponsor's last update on 10 Jan 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 reduction in ST use (time frame: 26 weeks). The study lists 4 primary outcomes in all. 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 10 Jan 2017.