Tobacco Use DisorderNCT00711100
Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers
A study testing Camel Snus, Marlboro Snus and Stonewall in people with Tobacco Use Disorder, run by University of Minnesota at 2 sites in United States.
Trial summary
Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. 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?
- Camel Snus, Marlboro Snus and Stonewall
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Dec 2010
- Phase
- Interventional
- 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
- Cigarette smokers who smoke 10 or more cigarettes per day
- Generally good health
Who cannot join
- Unstable medical or psychiatric condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 47404
Univeristy of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Preference, Health Effects and Efficacy of Four Oral Tobacco Products for Smoking Cessation
Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. These two studies will examine four oral tobacco products to answer some of these questions.
The goals of this first study will be to examine: 1) the brand of oral tobacco products which is preferred by cigarette smokers and the pattern and amount of product use when used as a switching tool; 2) the characteristics that are associated with product choice; 3) nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use.
Read more
Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most smokers will be based on taste and sensory aspects of the product with products higher in nicotine content more likely to be chosen as the preferred product; and 2) subjects will experience no difficulty using the product for complete cigarette substitution, but a small minority will engage in dual product use.
For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.
Read the detailed description
This study will be accomplished by allowing subjects to sample the products and choose one oral tobacco product that they will use instead of cigarettes for a two week period. After the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence rates will be observed.
Subjects will attend an orientation visit where the study will be explained in detail. Interested subjects will sign a consent form and be scheduled to return for baseline measures. Subjects will have a review of medical history to verify that they are in generally good health and do not have contraindications to the study products. Eligible subjects will collect one week of baseline measures while smoking at their normal rate: measures include daily diaries of smoking, questionnaires and urine samples. At the second baseline visit, they will receive samples of the oral tobacco products. The tobacco products tested are five novel oral products recently introduced to the market: 1) Camel Snus (higher nicotine); 2) General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two compressed tobacco tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine). All of these tobacco products are purported to have reduced levels of tobacco-specific nitrosamines.
During sample weeks, subjects will be given 10 pouches/tablets of each product in a within-subject design and instructed to use at least three of the daily products in the morning of sample day and resume smoking in the afternoon and through the following day. They will sample the next product in a similar manner. The order of product was randomized. All subjects will sample all five products. This design will allow a short, but adequate trial of each product to determine preference. After the sampling weeks, subjects will choose the product they will want to use to quit smoking. They will be supplied that product over the next two weeks.
During the two weeks of product use during smoking abstinence, subjects will come to weekly clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the end of treatment. At baseline, and 2 weeks post cigarette cessation, subjects will bring in a urine sample from their first morning void and bloods will be drawn. At each visit, subjects will have vital signs obtained (blood pressure, heart rate, weight and carbon monoxide level), they will complete several subjective forms regarding tobacco use, withdrawal symptoms, and mood. Subjects will receive brief behavioral counseling for smoking cessation at all visits.
In addition, during the sample weeks and at the end of two weeks of study product use, subjects will submit three used chews that will be sent to CDC to be analyzed for the tobacco constituents.
- Conditions
- Tobacco Use Disorder
- Being tested
- Camel Snus, Marlboro Snus, Stonewall, Ariva, General Snus
- Keywords
- Substitution for cigarettes, Oral tobacco products
- 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.
Camel SnusOther
All subjects will sample Camel Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Camel Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Camel Snus is chosen for use) during abstinence phase.
Marlboro SnusOther
All subjects will sample Marlboro Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Marlboro Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Marlboro Snus is chosen for use) during abstinence phase.
StonewallOther
All subjects will sample Stonewall and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Stonewall. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Stonewall is chosen for use) during abstinence phase.
ArivaOther
All subjects will sample Ariva and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Ariva. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Ariva is chosen for use) during abstinence phase.
General SnusOther
All subjects will sample General Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of General Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if General Snus is chosen for use) during abstinence phase.
| Study group | Role | What they receive |
|---|---|---|
| Camel Snus | Experimental | Camel Snus (oral smokeless tobacco product). Dosage: 1.74-1.97 mg nicotine per portion. Receives: Other: Camel Snus |
| Marlboro Snus | Experimental | Marlboro Snus (oral smokeless tobacco product). Dosage: 0.14 - 0.38 mg nicotine per portion. Receives: Other: Marlboro Snus |
| Stonewall | Experimental | Stonewall (oral dissolvable tobacco product). Dosage: 0.28-0.57 mg nicotine per portion. Receives: Other: Stonewall |
| Ariva | Experimental | Ariva (oral dissolvable tobacco product). Dosage: 0.24-0.25 mg nicotine per portion. Receives: Other: Ariva |
| General Snus | Experimental | General Snus (oral smokeless tobacco product); Dosage: 3.37 mg nicotine. Receives: Other: General Snus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Preference
Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).
Measured: 2 weeks
Abstinence From Cigarettes
Abstinence from cigarettes during Abstinence Phase.
Measured: Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionDec 2010
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711100
- Sponsor's protocol ID
- 0712M22343
- Other IDs
- 1R01CA135884
- Status last verified
- Oct 2019
- First submitted
- 2 Jul 2008
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference, Health Effects and Efficacy of Four Oral Tobacco Products for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00711100
- Acronym / sponsor ID
- 0712M22343
- Conditions
- Tobacco Use Disorder
- Keywords
- Substitution for cigarettes, Oral tobacco products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. These two studies will examine four oral tobacco products to answer some of these questions.
The goals of this first study will be to examine: 1) the brand of oral tobacco products which is preferred by cigarette smokers and the pattern and amount of product use when used as a switching tool; 2) the characteristics that are associated with product choice; 3) nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use.
Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most smokers will be based on taste and sensory aspects of the product with products higher in nicotine content more likely to be chosen as the preferred product; and 2) subjects will experience no difficulty using the product for complete cigarette substitution, but a small minority will engage in dual product use.
For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.
Detailed description
This study will be accomplished by allowing subjects to sample the products and choose one oral tobacco product that they will use instead of cigarettes for a two week period. After the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence rates will be observed.
Subjects will attend an orientation visit where the study will be explained in detail. Interested subjects will sign a consent form and be scheduled to return for baseline measures. Subjects will have a review of medical history to verify that they are in generally good health and do not have contraindications to the study products. Eligible subjects will collect one week of baseline measures while smoking at their normal rate: measures include daily diaries of smoking, questionnaires and urine samples. At the second baseline visit, they will receive samples of the oral tobacco products. The tobacco products tested are five novel oral products recently introduced to the market: 1) Camel Snus (higher nicotine); 2) General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two compressed tobacco tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine). All of these tobacco products are purported to have reduced levels of tobacco-specific nitrosamines.
During sample weeks, subjects will be given 10 pouches/tablets of each product in a within-subject design and instructed to use at least three of the daily products in the morning of sample day and resume smoking in the afternoon and through the following day. They will sample the next product in a similar manner. The order of product was randomized. All subjects will sample all five products. This design will allow a short, but adequate trial of each product to determine preference. After the sampling weeks, subjects will choose the product they will want to use to quit smoking. They will be supplied that product over the next two weeks.
During the two weeks of product use during smoking abstinence, subjects will come to weekly clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the end of treatment. At baseline, and 2 weeks post cigarette cessation, subjects will bring in a urine sample from their first morning void and bloods will be drawn. At each visit, subjects will have vital signs obtained (blood pressure, heart rate, weight and carbon monoxide level), they will complete several subjective forms regarding tobacco use, withdrawal symptoms, and mood. Subjects will receive brief behavioral counseling for smoking cessation at all visits.
In addition, during the sample weeks and at the end of two weeks of study product use, subjects will submit three used chews that will be sent to CDC to be analyzed for the tobacco constituents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Camel Snus | Experimental | Other: Camel SnusCamel Snus (oral smokeless tobacco product). Dosage: 1.74-1.97 mg nicotine per portion. |
| Marlboro Snus | Experimental | Other: Marlboro SnusMarlboro Snus (oral smokeless tobacco product). Dosage: 0.14 - 0.38 mg nicotine per portion. |
| Stonewall | Experimental | Other: StonewallStonewall (oral dissolvable tobacco product). Dosage: 0.28-0.57 mg nicotine per portion. |
| Ariva | Experimental | Other: ArivaAriva (oral dissolvable tobacco product). Dosage: 0.24-0.25 mg nicotine per portion. |
| General Snus | Experimental | Other: General SnusGeneral Snus (oral smokeless tobacco product); Dosage: 3.37 mg nicotine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cigarette smokers who smoke 10 or more cigarettes per day
- Generally good health
Key exclusion criteria (1 listed)
- Unstable medical or psychiatric condition.
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 |
|---|---|---|
| Camel SnusAll subjects will sample Camel Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Camel Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Camel Snus is chosen for use) during abstinence phase. | Other | Camel Snus |
| Marlboro SnusAll subjects will sample Marlboro Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Marlboro Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Marlboro Snus is chosen for use) during abstinence phase. | Other | Marlboro Snus |
| StonewallAll subjects will sample Stonewall and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Stonewall. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Stonewall is chosen for use) during abstinence phase. | Other | Stonewall |
| ArivaAll subjects will sample Ariva and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Ariva. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Ariva is chosen for use) during abstinence phase. | Other | Ariva |
| General SnusAll subjects will sample General Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of General Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if General Snus is chosen for use) during abstinence phase. | Other | General Snus |
Primary outcome
Product Preference
Time frame: 2 weeks
Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).
Abstinence From Cigarettes
Time frame: Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)
Abstinence from cigarettes during Abstinence Phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camel Snus, Marlboro Snus and Stonewall in people with Tobacco Use Disorder, run by University of Minnesota 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 2 inclusion and 1 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 18 Nov 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2015). 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?
Product Preference (time frame: 2 weeks). The study lists 2 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 18 Nov 2019.