Tobacco DependencePhase 2/3NCT00313105
Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
A Phase 2/3 study testing Smokeless tobacco (Oliver Twist pellets) and smoking cessation counseling in people with Tobacco Dependence, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches. Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Smokeless tobacco (Oliver Twist pellets) and smoking cessation counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2006to Aug 2010
- Phase
- Phase 2/3
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smokers (>7 cig/day)
- Healthy
- Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
- mild asthma and COPD,
- Motivated to quit smoking
- Motivated to follow the protocol
- Motivated to use medication in this trial
Who cannot join
- Severe diseases
- Psychiatric diseases
- Used NRT or Zyban the last 2 weeks
- Stopped smoking >2 days during last 3 months
- More than 6 alcoholic drinks per day
- Smokes other products than cigarettes
- Pregnant of lactating
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen, Hellerup, 2900
About this study
Official title: Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years
To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.
Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.
Read the detailed description
This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.
- Conditions
- Tobacco Dependence
- Being tested
- Smokeless tobacco (Oliver Twist pellets), smoking cessation counseling
- Keywords
- smoking cessation, smokeless tobacco, nicotine patch, nicotine buccal tablets, retreatment, adherence
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smokeless tobacco (Oliver Twist pellets)Drug
individual visits with counseling
smoking cessation counselingBehavioural
individual visits
| Study group | Role | What they receive |
|---|---|---|
| Smokeless Tobacco | Experimental | Smokeless Tobacco and individual visits Receives: Drug: Smokeless tobacco (Oliver Twist pellets); Behavioral: smoking cessation counseling |
| Nicotine tablets | Active comparator | Nicotine tablets Receives: Behavioral: smoking cessation counseling |
| 3 | Placebo comparator | 7-mg nicotine patch acts as placebo Receives: Behavioral: smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from smoking after ½ year (point and continuous abstinence)
Measured: 6 months from entry
Secondary outcomes (5)
Adverse events between 3 arms
Measured: Up to 6 months from entry
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
Measured: 3 and 6 months from entry
Adherence to study
Measured: 6,12,24 months from entry
Effect of retreatment (abstinence after 1, 1½ and 2 years)
Measured: 12,18 and 24 months from entry
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
Measured: 6,12,24 months from entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Foundation, FSS, Copenhagen, Denmark
- Investigators
- Philip Tønnesen, M.D., Ph.D., Principal investigator, Chair dept. pulm. medicine, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313105
- Sponsor's protocol ID
- 2005-004626-10
- Other IDs
- 2005
- Status last verified
- Sep 2009
- First submitted
- 10 Apr 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years
- ClinicalTrials.gov ID
- NCT00313105
- Acronym / sponsor ID
- 2005-004626-10
- Conditions
- Tobacco Dependence
- Keywords
- smoking cessation, smokeless tobacco, nicotine patch, nicotine buccal tablets, retreatment, adherence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Danish Research Foundation, FSS, Copenhagen, Denmark
- Study start
- Apr 2006
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 11 Apr 2006 (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.
To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.
Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.
Detailed description
This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokeless Tobacco | Experimental | Drug: Smokeless tobacco (Oliver Twist pellets), Behavioral: smoking cessation counselingSmokeless Tobacco and individual visits |
| Nicotine tablets | Active comparator | Behavioral: smoking cessation counselingNicotine tablets |
| 3 | Placebo comparator | Behavioral: smoking cessation counseling7-mg nicotine patch acts as placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- smokers (>7 cig/day)
- Healthy
- Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
- mild asthma and COPD,
- Motivated to quit smoking
Key exclusion criteria (7 listed)
- Severe diseases
- Psychiatric diseases
- Used NRT or Zyban the last 2 weeks
- Stopped smoking >2 days during last 3 months
- More than 6 alcoholic drinks per day
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 |
|---|---|---|
| Smokeless tobacco (Oliver Twist pellets)individual visits with counseling | Drug | Smokeless Tobacco |
| smoking cessation counselingindividual visits | Behavioural | 3, Nicotine tablets, Smokeless Tobacco |
Primary outcome
Abstinence from smoking after ½ year (point and continuous abstinence)
Time frame: 6 months from entry
5 secondary outcomes
Adverse events between 3 arms
Time frame: Up to 6 months from entry
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
Time frame: 3 and 6 months from entry
Adherence to study
Time frame: 6,12,24 months from entry
Effect of retreatment (abstinence after 1, 1½ and 2 years)
Time frame: 12,18 and 24 months from entry
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
Time frame: 6,12,24 months from entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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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.
Philip Tønnesen, M.D., Ph.D. principal investigator
Chair dept. pulm. medicine, Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Smokeless tobacco (Oliver Twist pellets) and smoking cessation counseling in people with Tobacco Dependence, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Sep 2009. 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Abstinence from smoking after ½ year (point and continuous abstinence) (time frame: 6 months from entry). 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 15 Sep 2009.