Smoking CessationPhase 4NCT01330043
Extended Treatment for Smoking Cessation
A Phase 4 study testing Bupropion, Nicotine patch and Varenicline in people with Smoking Cessation, run by Stanford University at 1 site in United States.
Trial summary
Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Bupropion, Nicotine patch and Varenicline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)
Who cannot join
- Currently pregnant
- Currently breastfeeding
- Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
- History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- Family history of seizures
- Currently using intravenous drugs
Show all 12Show fewer
- Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
- Currently using any over-the-counter stimulants and anorectics (diet pills)
- Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
- Currently on NRT or bupropion (Zyban)
- Current or past diagnosis of anorexia nervosa or bulimia nervosa
- Previous allergic response to bupropion or NRT
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.
Read the detailed description
During open label treatment, all receive CBT and bupropion and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.
- Conditions
- Smoking Cessation
- Being tested
- Bupropion, Nicotine patch, Varenicline
- Keywords
- smoking cessation intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban
Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
Nicotine patchDrug
Also called NRT
Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
VareniclineDrug
Also called Chantix
Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
| Study group | Role | What they receive |
|---|---|---|
| Non-extended treatment | Active comparator | * 26 weeks of CBT
* 10 weeks of combination bupropion plus nicotine patch
* Additional 16 weeks of bupropion plus nicotine patch if increased craving or depression scores or varenicline if smoking at 10 weeks Receives: Drug: Bupropion; Drug: Nicotine patch; Drug: Varenicline |
| Extended treatment | Experimental | * 26 weeks of CBT
* 10 weeks of combination bupropion plus nicotine patch
* Additional 16 weeks of bupropion plus nicotine patch if increased craving or depression scores or varenicline if smoking at 10 weeks
* 24 additional weeks of CBT Receives: Drug: Bupropion; Drug: Nicotine patch; Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired-air CO Verified Point-prevalence Abstinence
Self-reported no smoking in last 7 days verified by CO<10 ppm
Measured: 52 weeks
Secondary outcomes (1)
Expired-air CO Verified Point-prevalence Abstinence
Self-reported no smoking in last 7 days verified by CO<10 ppm
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2015
- Study completionMar 2015
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 Smoking CessationStudies of the same condition, open and under way.
- More trials run by Stanford 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to extended or non-extended treatment and followed for 104 weeks.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sean P. David, Stanford University
- Investigators
- Sean P. David, MD, DPhil, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330043
- Sponsor's protocol ID
- SU-09272010-6949
- Other IDs
- R01DA017441
- Status last verified
- Jul 2017
- First submitted
- 7 Oct 2010
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leyro TM, Crew EE, Bryson SW, Lembke A, Bailey SR, Prochaska JJ, Henriksen L, Fortmann SP, Killen JD, Killen DT, Hall SM, David SP. Retrospective analysis of changing characteristics of treatment-seeking smokers: implications for further reducing smoking prevalence. BMJ Open. 2016 Jun 29;6(6):e010960. doi: 10.1136/bmjopen-2015-010960.
PubMed 27357195Laude JR, Bailey SR, Crew E, Varady A, Lembke A, McFall D, Jeon A, Killen D, Killen JD, David SP. Extended treatment for cigarette smoking cessation: a randomized control trial. Addiction. 2017 Aug;112(8):1451-1459. doi: 10.1111/add.13806. Epub 2017 May 2.
PubMed 28239942
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Treatment for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01330043
- Acronym / sponsor ID
- SU-09272010-6949
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.
Detailed description
During open label treatment, all receive CBT and bupropion and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Participants were randomized to extended or non-extended treatment and followed for 104 weeks.
| Arm | Type | Receives |
|---|---|---|
| Non-extended treatment | Active comparator | Drug: Bupropion, Drug: Nicotine patch, Drug: Varenicline* 26 weeks of CBT * 10 weeks of combination bupropion plus nicotine patch * Additional 16 weeks of bupropion plus nicotine patch if increased craving or depression scores or varenicline if smoking at 10 weeks |
| Extended treatment | Experimental | Drug: Bupropion, Drug: Nicotine patch, Drug: Varenicline* 26 weeks of CBT * 10 weeks of combination bupropion plus nicotine patch * Additional 16 weeks of bupropion plus nicotine patch if increased craving or depression scores or varenicline if smoking at 10 weeks * 24 additional weeks of CBT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)
Key exclusion criteria (12 listed)
- Currently pregnant
- Currently breastfeeding
- Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
- History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- Family history of seizures
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 |
|---|---|---|
| BupropionAlso: ZybanBoth groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26. | Drug | Extended treatment, Non-extended treatment |
| Nicotine patchAlso: NRTBoth groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26. | Drug | Extended treatment, Non-extended treatment |
| VareniclineAlso: ChantixBoth groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26. | Drug | Extended treatment, Non-extended treatment |
Primary outcome
Expired-air CO Verified Point-prevalence Abstinence
Time frame: 52 weeks
Self-reported no smoking in last 7 days verified by CO<10 ppm
1 secondary outcome
Expired-air CO Verified Point-prevalence Abstinence
Time frame: 104 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27357195Leyro TM, Crew EE, Bryson SW, Lembke A, Bailey SR, Prochaska JJ, Henriksen L, Fortmann SP, Killen JD, Killen DT, Hall SM, David SP. Retrospective analysis of changing characteristics of treatment-seeking smokers: implications for further reducing smoking prevalence. BMJ Open. 2016 Jun 29;6(6):e010960. doi: 10.1136/bmjopen-2015-010960.
- Results publication: PubMed 28239942Laude JR, Bailey SR, Crew E, Varady A, Lembke A, McFall D, Jeon A, Killen D, Killen JD, David SP. Extended treatment for cigarette smoking cessation: a randomized control trial. Addiction. 2017 Aug;112(8):1451-1459. doi: 10.1111/add.13806. Epub 2017 May 2.
- Individual participant dataSharing planned: Undecided
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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.
Sean P. David, MD, DPhil principal investigator
Stanford University
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 Bupropion, Nicotine patch and Varenicline in people with Smoking Cessation, run by Stanford University 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 12 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 1 Aug 2017. 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 1 Aug 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?
Expired-air CO Verified Point-prevalence Abstinence (time frame: 52 weeks). 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 NCT01330043, 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 1 Aug 2017.