Smokeless TobaccoNCT01100216
Human Laboratory Study of Smokeless Tobacco Products
A study testing Nicotine Lozenge, Stonewall Dissolvable Tobacco Pieces and Camel Snus Frost in people with Smokeless Tobacco, run by University of Minnesota at 1 site in United States.
Trial summary
With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco
- What is being tested?
- Nicotine Lozenge, Stonewall Dissolvable Tobacco Pieces and Camel Snus Frost
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2010
- Phase
- Interventional
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT.
- Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant.
- Subjects will have used SLT for at least 1 year..
- Subjects will be English speaking and reading.
- Provide written informed consent.
Who cannot join
- Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months.
- Subjects who take medications that might affect the outcome of laboratory measures.
- Subjects with a history of major mood, thought, anxiety or attentional disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tobacco Research Center
Minneapolis, Minnesota, 55455
About this study
With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.
Read the detailed description
Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.
- Conditions
- Smokeless Tobacco
- Being tested
- Nicotine Lozenge, Stonewall Dissolvable Tobacco Pieces, Camel Snus Frost, Skoal Wintergreen
- Keywords
- smokeless tobacco, nicotine, snus, snuff, chewing tobacco, oral tobacco
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine LozengeOther
Also called Commit Nicotine Lozenge
4 mg for 12 days
Stonewall Dissolvable Tobacco PiecesOther
Also called Stonewall Spearmint Tablet
5.6 mg nicotine pieces for 12 days
Camel Snus FrostOther
Also called Camel Snus Frost Pouches
pouches, 6.2 mg nicotine, for 12 days
Skoal WintergreenOther
Also called Skoal
Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Lozenge | Active comparator | 4 mg nicotine lozenge (LOZ Receives: Other: Nicotine Lozenge |
| Camel Snus Frost | Active comparator | Not described Receives: Other: Camel Snus Frost |
| Stonewall Spearment Tablet | Active comparator | Not described Receives: Other: Stonewall Dissolvable Tobacco Pieces |
| Skoal Wintergreen | Active comparator | Not described Receives: Other: Skoal Wintergreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal Severity
Comparing withdrawal symptoms between the different products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
Measured: Week 10
Secondary outcomes (3)
Cognition Impairments
Comparing differences between the smokeless tobacco products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
Measured: Week 10
Startle Response
Negative emotional responses to nicotine-relevant stimulant (based on physiologoical and electrophysiological measures, and self-reports of affective valence, arousal and control/dominance) differences between products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
Measured: Week 10
Reinforcement
The break point (response workload at which subjects do not respond sufficiently to obtain a dosage of product in a defined time period) is expected to differ significantly between products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Funding expired prior to implementing subject recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokeless TobaccoStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Mooney, Ph.D., Principal investigator, Dept. Psychiatry, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100216
- Sponsor's protocol ID
- 2009NTLS097
- Other IDs
- 0911M74614
- Status last verified
- Dec 2014
- First submitted
- 6 Apr 2010
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Study of Smokeless Tobacco Products
- ClinicalTrials.gov ID
- NCT01100216
- Acronym / sponsor ID
- 2009NTLS097
- Conditions
- Smokeless Tobacco
- Keywords
- smokeless tobacco, nicotine, snus, snuff, chewing tobacco, oral tobacco
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding expired prior to implementing subject recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Apr 2010 (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.
With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.
Detailed description
Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine Lozenge | Active comparator | Other: Nicotine Lozenge4 mg nicotine lozenge (LOZ |
| Camel Snus Frost | Active comparator | Other: Camel Snus Frost |
| Stonewall Spearment Tablet | Active comparator | Other: Stonewall Dissolvable Tobacco Pieces |
| Skoal Wintergreen | Active comparator | Other: Skoal Wintergreen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT.
- Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant.
- Subjects will have used SLT for at least 1 year..
- Subjects will be English speaking and reading.
- Provide written informed consent.
Key exclusion criteria (3 listed)
- Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months.
- Subjects who take medications that might affect the outcome of laboratory measures.
- Subjects with a history of major mood, thought, anxiety or attentional disorders.
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 LozengeAlso: Commit Nicotine Lozenge4 mg for 12 days | Other | Nicotine Lozenge |
| Stonewall Dissolvable Tobacco PiecesAlso: Stonewall Spearmint Tablet5.6 mg nicotine pieces for 12 days | Other | Stonewall Spearment Tablet |
| Camel Snus FrostAlso: Camel Snus Frost Pouchespouches, 6.2 mg nicotine, for 12 days | Other | Camel Snus Frost |
| Skoal WintergreenAlso: SkoalUsed at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period. | Other | Skoal Wintergreen |
Primary outcome
Withdrawal Severity
Time frame: Week 10
Comparing withdrawal symptoms between the different products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
3 secondary outcomes
Cognition Impairments
Time frame: Week 10
Startle Response
Time frame: Week 10
Reinforcement
Time frame: Week 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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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.
Marc Mooney, Ph.D. principal investigator
Dept. Psychiatry, 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 study testing Nicotine Lozenge, Stonewall Dissolvable Tobacco Pieces and Camel Snus Frost in people with Smokeless Tobacco, 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Dec 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Withdrawal Severity (time frame: Week 10). 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 Dec 2014.