Cigarette SmokingPhase 2/3LiveForLife2NCT01560507
Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
A Phase 2/3 study testing varenicline (Chantix), bupropion (Zyban) and nicotine patches in people with Cigarette Smoking and Nicotine Dependence, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an adaptive treatment algorithm developed in previous clinical trials, in order to calculate cost-effectiveness of the treatment; 2) the relationship between genotype and response to cigarette smoking cessation treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cigarette Smoking, Nicotine Dependence
- What is being tested?
- varenicline (Chantix), bupropion (Zyban) and nicotine patches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jul 2013
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duke employees who are enrolled in a Duke Health Plan and intend to remain employed at Duke for the next six months;
- Dependents of Duke employees who meet the above criteria;
- 18-65 years old;
- Currently smoke an average of at least 10 cigarettes per day;
- Willing to take Chantix or Zyban;
- Express a desire to quit smoking within the next 30 days.
Who cannot join
- Hypertension;
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);
- Coronary heart disease;
- Lifetime history of heart attack;
- Cardiac rhythm disorder (irregular heart rhythm);
- Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
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- Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
- Extensive active skin disorder;
- Liver or kidney disorder (except kidney stones, gallstones);
- Gastrointestinal disease other than gastroesophageal reflux or heartburn;
- Active ulcers in the past 30 days;
- Currently symptomatic lung disorder/disease (including but not limited to COPD, emphysema, and asthma);
- Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
- Migraine headaches that occur more frequently than once per week;
- Recent, unexplained fainting spells;
- Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
- Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
- Other major medical condition;
- Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
- Pregnant or nursing mothers;
- Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);
- Current depression;
- Bulimia or anorexia;
- Alcohol abuse;
- Significant adverse reaction to bupropion/Wellbutrin/Zyban, Chantix/Varenicline or nicotine patches in the past.
- Use (within the past 30 days) of:
- Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
- Medications that are known to affect smoking cessation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Center forSmoking Cessation
Durham, North Carolina, 27705
Duke Center for Smoking Cessation
Raleigh, North Carolina, 27609
About this study
The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an adaptive treatment algorithm developed in previous clinical trials, in order to calculate cost-effectiveness of the treatment; 2) the relationship between genotype and response to cigarette smoking cessation treatment.
Read the detailed description
Previous research has shown that the initial response to nicotine patch treatment can be used to decide whether the patch alone is likely to help smokers to quit or whether alternative prescription medications may be needed to achieve smoking abstinence. This study applies the knowledge gained from this previous research to adapt the smoking cessation treatment provided to participants, based on their degree of smoking reduction during the first four weeks of nicotine patch treatment. By demonstrating effectiveness of this algorithm, this study may lead to further dissemination of the adaptive treatment strategy to other health care settings. Additionally, by gathering further information relating genomic markers to outcome, the foundation will be laid for potential practical application of this index in other settings.
- Conditions
- Cigarette Smoking, Nicotine Dependence
- Being tested
- varenicline (Chantix), bupropion (Zyban), nicotine patches
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varenicline (Chantix)Drug
Also called Chantix, varenicline
For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
bupropion (Zyban)Drug
Also called Zyban, bupropion
After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
nicotine patchesDrug
21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| varenicline (Chantix) | Active comparator | This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation Nicotine Replacement Therapy (NRT) assessed the day before the scheduled quit day. They will receive varenicline. Receives: Drug: varenicline (Chantix) |
| nicotine patches | Active comparator | This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They will continue to using only nicotine patches. Receives: Drug: nicotine patches |
| bupropion (Zyban) and nicotine patches | Active comparator | This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They will receive bupropion with nicotine patches. Receives: Drug: bupropion (Zyban); Drug: nicotine patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Measured: End of study drug treatment period (11-12 weeks)
Secondary outcomes (1)
Quit Success Genotype Score
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed."
Measured: After 6 month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Low Recruitment
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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris USA, Inc.
- Responsible party
- Sponsor
- Investigators
- Jed E Rose, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560507
- Sponsor's protocol ID
- Pro00032605
- Acronym
- LiveForLife2
- Status last verified
- Nov 2014
- First submitted
- 20 Mar 2012
- Last updated
- 24 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
- ClinicalTrials.gov ID
- NCT01560507
- Acronym / sponsor ID
- LiveForLife2 / Pro00032605
- Conditions
- Cigarette Smoking, Nicotine Dependence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Philip Morris USA, Inc.
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Posted 19 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an adaptive treatment algorithm developed in previous clinical trials, in order to calculate cost-effectiveness of the treatment; 2) the relationship between genotype and response to cigarette smoking cessation treatment.
Detailed description
Previous research has shown that the initial response to nicotine patch treatment can be used to decide whether the patch alone is likely to help smokers to quit or whether alternative prescription medications may be needed to achieve smoking abstinence. This study applies the knowledge gained from this previous research to adapt the smoking cessation treatment provided to participants, based on their degree of smoking reduction during the first four weeks of nicotine patch treatment. By demonstrating effectiveness of this algorithm, this study may lead to further dissemination of the adaptive treatment strategy to other health care settings. Additionally, by gathering further information relating genomic markers to outcome, the foundation will be laid for potential practical application of this index in other settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| varenicline (Chantix) | Active comparator | Drug: varenicline (Chantix)This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation Nicotine Replacement Therapy (NRT) assessed the day before the scheduled quit day. They will receive varenicline. |
| nicotine patches | Active comparator | Drug: nicotine patchesThis group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They will continue to using only nicotine patches. |
| bupropion (Zyban) and nicotine patches | Active comparator | Drug: bupropion (Zyban), Drug: nicotine patchesThis group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They will receive bupropion with nicotine patches. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Duke employees who are enrolled in a Duke Health Plan and intend to remain employed at Duke for the next six months;
- Dependents of Duke employees who meet the above criteria;
- 18-65 years old;
- Currently smoke an average of at least 10 cigarettes per day;
- Willing to take Chantix or Zyban;
Key exclusion criteria (28 listed)
- Hypertension;
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);
- Coronary heart disease;
- Lifetime history of heart attack;
- Cardiac rhythm disorder (irregular heart rhythm);
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 |
|---|---|---|
| varenicline (Chantix)Also: Chantix, vareniclineFor the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. | Drug | varenicline (Chantix) |
| bupropion (Zyban)Also: Zyban, bupropionAfter being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks. | Drug | bupropion (Zyban) and nicotine patches |
| nicotine patches21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks. | Drug | bupropion (Zyban) and nicotine patches, nicotine patches |
Primary outcome
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
Time frame: End of study drug treatment period (11-12 weeks)
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
1 secondary outcome
Quit Success Genotype Score
Time frame: After 6 month Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jed E Rose, Ph.D. principal investigator
Duke University
2 sites 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 varenicline (Chantix), bupropion (Zyban) and nicotine patches in people with Cigarette Smoking and Nicotine Dependence, run by Duke University 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 6 inclusion and 28 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: stopped early, as of the sponsor's last update on 24 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 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 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?
Yes. Results are posted in the registry (first posted 19 Nov 2013). 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?
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation (time frame: End of study drug treatment period (11-12 weeks)). 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 24 Dec 2014.