Smoking CessationPhase 4NCT01078298
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
A Phase 4 study testing varenicline in people with Smoking Cessation and Depression, run by Pfizer at 41 sites in 8 countries.
Trial summary
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation, Depression
- What is being tested?
- varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 525 participants
- Where
- 41 sitesin 8 countries
- Study dates
- Mar 2010to Jun 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
- Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening
- Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
- On stable antidepressant treatment for MDD (stable dose for at least 2 months)
- Major depressive episode, using DSM IV TR, in the past 2 years successfully treated
Who cannot join
- Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
- Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
- Current use of either bupropion or nortryptiline.
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
United States17 sites
Behavioral Health and Wellness Program, University of Colorado Denver
Aurora, Colorado, 80045
FutureSearch Trials
Austin, Texas, 78731
Clinical Trials of Memphis
Bartlett, Tennessee, 38134
NorthCoast Clinical Trials Inc.
Beachwood, Ohio, 44122
University of Cincinnati
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45237
Emerald Coast Mood & Memory, PA
Fort Walton Beach, Florida, 32547
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, 77008
Clinical Neuroscience Solutions Incorporated
Jacksonville, Florida, 32216
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Clinical Neuroscience Solutions Incorporated
Orlando, Florida, 32806
Vince and Associates Clinical Research
Overland, Kansas, 66211
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
CRI Worldwide LLC
Philadelphia, Pennsylvania, 19139
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Hungary6 sites
Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
Budapest, 1135
Processus Kft., Varoskapu Rendelo
Budapest, 1137
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
Gyula, 5700
Varosi Egeszsegugyi Kozpont
Kunszentmárton, 5440
Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
Székesfehérvár, 8000
Donatella 99 Bt.
Szentes, 6600
Russia4 sites
Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
Moscow, 107076
Institution of Russian Academy of Medical Sciences Mental Health Research Center
Moscow, 115522
Moscow State Healthcare Institution Clinical Mental Hospital No 12
Moscow, 125367
St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
Saint Petersburg, 190121
Spain4 sites
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, 08025
Hospital General de La Vall D'Hebron
Barcelona, Barcelona, 08035
Centro de Salud Mental Ii "La Corredoria"
Oviedo, Principality of Asturias, 33011
Centro de Salud Torrero La Paz
Zaragoza, Zaragoza, 50007
Germany3 sites
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79104
Ludwig Maximilians-Universitaet Muenchen
München, 80336
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
Tübingen, 72076
Romania3 sites
Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
Bucharest, Sector 4
Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
Bucharest, 041902
Spitalul Clinic de Psihiatrie Socola, sectia VII
Iași, Iaşi, 700282
Bosnia and Herzegovina2 sites
Psychiatric Clinic, Clinical Center Banja Luka
Banja Luka, 78000
Clinic of Psychiatry, Clinical Center University of Sarajevo
Sarajevo, 71000
Croatia2 sites
"Poliklinika Neuron" - Croatian Institute for Brain Research
Zagreb, 10000
Psychiatric Hospital Vrapce
Zagreb, 10000
About this study
Official title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
- Conditions
- Smoking Cessation, Depression
- Being tested
- varenicline, placebo
- Keywords
- smoking, smoking cessation, smoking cessation in depressed subjects
- Medical subject headings
- Smoking Cessation, Depression, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Champix/Chantix
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
placeboDrug
placebo tablets matched in appearance and dosage to varenicline tablets
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Experimental | Not described Receives: Drug: varenicline |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
Measured: Week 9 through Week 12
Secondary outcomes (3)
Percentage of Participants With Continuous Abstinence Rate (CAR)
Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Measured: Week 9 through Week 24, Week 9 through Week 52
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Measured: Weeks 12, 24, 52
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 2012
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 PfizerThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078298
- Sponsor's protocol ID
- A3051122
- Status last verified
- Mar 2013
- First submitted
- 26 Feb 2010
- Last updated
- 16 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005.
PubMed 24042367
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
- ClinicalTrials.gov ID
- NCT01078298
- Acronym / sponsor ID
- A3051122
- Conditions
- Smoking Cessation, Depression
- Keywords
- smoking, smoking cessation, smoking cessation in depressed subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 16 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Experimental | Drug: varenicline |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
- Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening
- Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
- On stable antidepressant treatment for MDD (stable dose for at least 2 months)
- Major depressive episode, using DSM IV TR, in the past 2 years successfully treated
Key exclusion criteria (3 listed)
- Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
- Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
- Current use of either bupropion or nortryptiline.
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 |
|---|---|---|
| vareniclineAlso: Champix/Chantixvarenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks | Drug | varenicline |
| placeboplacebo tablets matched in appearance and dosage to varenicline tablets | Drug | placebo |
Primary outcome
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Time frame: Week 9 through Week 12
Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
3 secondary outcomes
Percentage of Participants With Continuous Abstinence Rate (CAR)
Time frame: Week 9 through Week 24, Week 9 through Week 52
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Time frame: Weeks 12, 24, 52
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 24042367Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing varenicline in people with Smoking Cessation and Depression, run by Pfizer at 41 sites in 8 countries.
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 5 inclusion and 3 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 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Hungary, Russia, Spain, Germany and 3 more countries. 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 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 16 Apr 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?
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (time frame: Week 9 through Week 12). 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 NCT01078298, 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 16 Apr 2013.