Tobacco DependencePhase 4NCT00296647
Smoking Cessation Intervention: Effectiveness in Primary Care
A Phase 4 study testing nicotine patch, nicotine lozenge and bupropion in people with Tobacco Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- nicotine patch, nicotine lozenge and bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,346 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient
Who cannot join
- Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
UW-CTRI Milwaukee Research site
Milwaukee, Wisconsin, 53233
About this study
Official title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.
Read the detailed description
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.
- Conditions
- Tobacco Dependence
- Being tested
- nicotine patch, nicotine lozenge, bupropion, patch + lozenge, bupropion + lozenge
- 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.
nicotine patchDrug
Decreasing dosages from 21 to 7 mg over 12 week period
nicotine patchDrug
Decreasing dosage from 21 to 7 mg over 12 weeks
nicotine lozengeDrug
4 mg nicotine lozenge: dosage according to package directions for 16 weeks
bupropionDrug
dosage according to prescription directions: 12 weeks
patch + lozengeDrug
dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
bupropion + lozengeDrug
dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
| Study group | Role | What they receive |
|---|---|---|
| patch | Active comparator | Not described Receives: Drug: nicotine patch |
| nicotine lozenge | Active comparator | Not described Receives: Drug: nicotine lozenge |
| bupropion | Active comparator | Not described Receives: Drug: bupropion |
| patch + lozenge | Active comparator | Not described Receives: Drug: patch + lozenge |
| buproion + lozenge | Active comparator | Not described Receives: Drug: bupropion + lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Self-reported Abstinence From Smoking
Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startSep 2004
- Primary completionJul 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Thomas C Jackson, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296647
- Sponsor's protocol ID
- H-2004-0462
- Other IDs
- P50DA019706
- Status last verified
- Oct 2015
- First submitted
- 24 Feb 2006
- Last updated
- 14 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hockenberry JM, Curry SJ, Fishman PA, Baker TB, Fraser DL, Cisler RA, Jackson TC, Fiore MC. Healthcare costs around the time of smoking cessation. Am J Prev Med. 2012 Jun;42(6):596-601. doi: 10.1016/j.amepre.2012.02.019.
PubMed 22608375Smith SS, McCarthy DE, Japuntich SJ, Christiansen B, Piper ME, Jorenby DE, Fraser DL, Fiore MC, Baker TB, Jackson TC. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med. 2009 Dec 14;169(22):2148-55. doi: 10.1001/archinternmed.2009.426.
PubMed 20008701
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
- ClinicalTrials.gov ID
- NCT00296647
- Acronym / sponsor ID
- H-2004-0462
- Conditions
- Tobacco Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,346 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Posted 30 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.
Detailed description
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| patch | Active comparator | Drug: nicotine patch |
| nicotine lozenge | Active comparator | Drug: nicotine lozenge |
| bupropion | Active comparator | Drug: bupropion |
| patch + lozenge | Active comparator | Drug: patch + lozenge |
| buproion + lozenge | Active comparator | Drug: bupropion + lozenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient
Key exclusion criteria (1 listed)
- Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
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 patchDecreasing dosages from 21 to 7 mg over 12 week period | Drug | patch |
| nicotine patchDecreasing dosage from 21 to 7 mg over 12 weeks | Drug | patch |
| nicotine lozenge4 mg nicotine lozenge: dosage according to package directions for 16 weeks | Drug | nicotine lozenge |
| bupropiondosage according to prescription directions: 12 weeks | Drug | bupropion |
| patch + lozengedosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge) | Drug | patch + lozenge |
| bupropion + lozengedosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge) | Drug | buproion + lozenge |
Primary outcome
6 Month Self-reported Abstinence From Smoking
Time frame: 6 months
Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22608375Hockenberry JM, Curry SJ, Fishman PA, Baker TB, Fraser DL, Cisler RA, Jackson TC, Fiore MC. Healthcare costs around the time of smoking cessation. Am J Prev Med. 2012 Jun;42(6):596-601. doi: 10.1016/j.amepre.2012.02.019.
- Derived from this study: PubMed 20008701Smith SS, McCarthy DE, Japuntich SJ, Christiansen B, Piper ME, Jorenby DE, Fraser DL, Fiore MC, Baker TB, Jackson TC. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med. 2009 Dec 14;169(22):2148-55. doi: 10.1001/archinternmed.2009.426.
- web site of the study lead investigatorsLink provided by the sponsor.
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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.
Thomas C Jackson, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nicotine patch, nicotine lozenge and bupropion in people with Tobacco Dependence, run by University of Wisconsin, Madison 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 1 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 14 Oct 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 Nov 2011). 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?
6 Month Self-reported Abstinence From Smoking (time frame: 6 months). 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 NCT00296647, which also lists 2 linked publications.
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 14 Oct 2015.