Tobacco Use DisorderPhase 2NCT00710034
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
A Phase 2 study testing Oral tobacco and Nicotine Gum in people with Tobacco Use Disorder, run by University of Minnesota at 2 sites in United States.
Trial summary
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate… 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?
- Oral tobacco and Nicotine Gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to May 2014
- 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
- smoking at least 10 cigarettes daily for the past year,
- in good physical health (no unstable medical condition;
- no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
Who cannot join
- Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.
For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.
Read the detailed description
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).
- Conditions
- Tobacco Use Disorder
- Being tested
- Oral tobacco, Nicotine Gum
- Keywords
- Oral Tobacco Products, Snus, Smoking Substitution, Harm Reduction, Biomarkers of Tobacco Exposure
- Medical subject headings
- Tobacco Use Disorder, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tobaccoOther
Also called Camel Snus
Snus
Nicotine GumDrug
Also called Nicorette
4 mg Nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Gum | Active comparator | Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12. Receives: Drug: Nicotine Gum |
| Snus | Experimental | Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12. Receives: Other: Oral tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Effect on Complete Substitution for Smoking
Number of subjects using only the assigned study product at week 6
Measured: 6 week post smoking substitution
Number of Cigarettes Smoked
Cigarettes per day at mid intervention
Measured: 6 weeks post cigarette substitution
Number of Products Used
Pieces of product per week at mid intervention
Measured: 6 weeks post smoking substitution
Secondary outcomes (2)
Products Effect on Withdrawal Symptoms.
Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.
Measured: Week 1-12 post switching
Product Effect on Biomarkers of Exposure and Toxicity
Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).
Measured: Baseline and Week 4 post smoking substitution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startApr 2010
- Primary completionMay 2013
- Study completionMay 2014
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
- 391 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
- NCT00710034
- Sponsor's protocol ID
- 1R01 CA135884-2
- Other IDs
- 1R01CA135884
- Status last verified
- Oct 2017
- First submitted
- 2 Jul 2008
- Last updated
- 6 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will share data with both internal and external researchers. Those external researchers interested in accessing the data will be required to submit a data analyses proposal with specific aims, hypotheses, and data analyses plan. These proposals will be reviewed by the investigative team. The requested data will then be provided that includes the variable list, raw data and description of the measures and methods of data collection.
Publications
Hatsukami DK, Severson H, Anderson A, Vogel RI, Jensen J, Broadbent B, Murphy SE, Carmella S, Hecht SS. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching. Tob Control. 2016 May;25(3):267-74. doi: 10.1136/tobaccocontrol-2014-052080. Epub 2015 May 19.
PubMed 25991608
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking
- ClinicalTrials.gov ID
- NCT00710034
- Acronym / sponsor ID
- 1R01 CA135884-2
- Conditions
- Tobacco Use Disorder
- Keywords
- Oral Tobacco Products, Snus, Smoking Substitution, Harm Reduction, Biomarkers of Tobacco Exposure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.
For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.
Detailed description
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Gum | Active comparator | Drug: Nicotine GumNicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12. |
| Snus | Experimental | Other: Oral tobaccoOral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- smoking at least 10 cigarettes daily for the past year,
- in good physical health (no unstable medical condition;
- no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
Key exclusion criteria (1 listed)
- Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
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 |
|---|---|---|
| Oral tobaccoAlso: Camel SnusSnus | Other | Snus |
| Nicotine GumAlso: Nicorette4 mg Nicotine gum | Drug | Nicotine Gum |
Primary outcome
Product Effect on Complete Substitution for Smoking
Time frame: 6 week post smoking substitution
Number of subjects using only the assigned study product at week 6
Number of Cigarettes Smoked
Time frame: 6 weeks post cigarette substitution
Cigarettes per day at mid intervention
Number of Products Used
Time frame: 6 weeks post smoking substitution
Pieces of product per week at mid intervention
2 secondary outcomes
Products Effect on Withdrawal Symptoms.
Time frame: Week 1-12 post switching
Product Effect on Biomarkers of Exposure and Toxicity
Time frame: Baseline and Week 4 post smoking substitution
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25991608Hatsukami DK, Severson H, Anderson A, Vogel RI, Jensen J, Broadbent B, Murphy SE, Carmella S, Hecht SS. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching. Tob Control. 2016 May;25(3):267-74. doi: 10.1136/tobaccocontrol-2014-052080. Epub 2015 May 19.
- Individual participant dataSharing planned: Yes. We will share data with both internal and external researchers. Those external researchers interested in accessing the data will be required to submit a data analyses proposal with specific aims, hypotheses, and data analyses plan. These proposals will be reviewed by the investigative team. The requested data will then be provided that includes the variable list, raw data and description of the measures and methods of data collection.
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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 Phase 2 study testing Oral tobacco and Nicotine Gum 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 3 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 6 Dec 2017. 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.
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 6 Dec 2017). 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 Effect on Complete Substitution for Smoking (time frame: 6 week post smoking substitution). The study lists 3 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 NCT00710034, 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 6 Dec 2017.