Acute Coronary SyndromePhase 3ZESCANCT00689611
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
A Phase 3 study testing Bupropion HCl ER in people with Acute Coronary Syndrome and Myocardial Infarction, run by Mark Eisenberg at 38 sites in 7 countries.
Trial summary
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Smoking
- What is being tested?
- Bupropion HCl ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 38 sitesin 7 countries
- Study dates
- Dec 2005to Jun 2010
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Smoke at least 10 cigarettes/day for the past year
- Suffered an enzyme-positive ACS
- Planned hospitalization of ≥24 hours
- Motivated to quit smoking
- Likely to be available for follow-up
- Able to understand and read English or French
Who cannot join
- Medical condition with a prognosis of < 1 year
- Pregnant or lactating
- Current use of Wellbutrin or any other medications that contain bupropion
- Current use of any medical therapy for smoking cessation (e.g. BuSpar, fluoxetine, doxepin, nicotine gum, or nicotine patch)
- Current seizure disorder, history of seizures or predisposition to seizures (e.g. history of brain tumor, severe head trauma, or stroke)
- History of bulimia or anorexia nervosa
Show all 15Show fewer
- Current diagnosis of major depression (requiring medication), bipolar disease, or dementia
- History of suicidal events (previous suicide attempt, suicidal ideation) or family history of suicide
- Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST or ALT levels ≥ 2 times upper limit of normal prior to admission for ACS)
- Renal impairment with creatinine levels ≥ 2 times the upper limit of normal
- Excessive alcohol consumption defined as ≥ 14 alcoholic drinks per week
- Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates)
- Current use of medications that lower seizure threshold e.g. amantadine, anti-depressants, anti-malarials, anti-psychotics, levodopa, lithium, quinolone antibiotics, ritonavir, systemic steroids, theophyllin, type 1C antiarrhythmics (e.g. encainide, flecainide, propafenone)
- Use of MAO inhibitors or thioridazine in the past 15 days
- Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or anoretics
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
Canada20 sites
Peter Lougheed Centre of the Calgary General Hospital
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta
Valley Regional Hospital
Kentville, Nova Scotia
Hopital de la Cite de la Sante
Laval, Quebec, H7M 3L9
CHA Hotel-Dieu de Levis
Lévis, Quebec
SMBD- Jewish General Hospital
Montreal, Quebec, H3T 1E2
Hopital Sacre-Coeur de Montreal
Montreal, Quebec
Hotel-Dieu
Montreal, Quebec
Montreal General Hospital
Montreal, Quebec
The Ottawa Hospital, General Campus
Ottawa, Ontario
Hopital Laval
Québec, Quebec, G1V 4G5
New Brunswick Heart Centre
Saint Johns, New Brunswick
Saskatchewan Drug Research Institute
Saskatoon, Saskatchewan, S7N 0W8
Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
CSSS de Sorel-Tracy
Sorel-Tracy, Quebec
CSSS de la Region de Thetford
Thetford-Mines, Quebec
St. Michael's Hospital
Toronto, Ontario
Vancouver Coastal Health
Vancouver, British Columbia, V5M 1L9
Victoria General Hospital
Winnipeg, Manitoba, R3T 2E8
St. Boniface General Hospital
Winnipeg, Manitoba
United States13 sites
Bay Regional Medical Center
Bay City, Michigan
Medical University of South Carolina
Charleston, South Carolina, 29403
Bassett Healthcare
Cooperstown, New York, 13326
United Health Services
Johnson City, New York, 13790
Schuster Cardiology
Kettering, Ohio, 45429
Southwest Cardiology
Kettering, Ohio, 45429
Central Maine Medical Center
Lewiston, Maine, 04240
Riverside Hospital
Newport News, Virginia, 23601
DVA Medical Center
Oklahoma City, Oklahoma, 73104
Parkview Medcial Center
Pueblo, Colorado, 81003
Advanced Cardiology Specialists
Scranton, Pennsylvania, 18501
Charleston Area Medical Center
South Charleston, West Virginia, 25309
Stony Brook Hospital and Medical Center
Stony Brook, New York, 11794-8167
About this study
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.
Read the detailed description
Patients who continue smoking after ACS have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an acute coronary syndrome (ACS), but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects. Bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers by approximately 50%. Although bupropion has successfully been used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown.
The ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS. The ZESCA Trial will be a multi-center effort, coordinated from the Jewish General Hospital/McGill University (Montreal, Quebec). A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site. Prior to the start of the treatment, patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation. Patients will begin treatment in-hospital and will be monitored in-hospital for ≥ 2 days prior to discharge. Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks. Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks. Prior to discharge, the patients will receive an information sheet listing the possible side effects of bupropion. They will be advised to consult the treating physician should they experience any listed side effects. While in-hospital, patients will have quit smoking and they will be instructed to not restart smoking when discharged. Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period. In addition, the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12. Smoking abstinence will be assessed at 4 weeks, 9 weeks, 6 months, and 12 months after randomization. Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide ≤ 10 ppm. Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 (by telephone calls), and weeks 4 and 9 as well as months 6 and 12 (by clinic visits). Withdrawal symptoms will also be assessed by the nurses during their weekly calls.
Trials previously conducted with bupropion involved young healthy smokers. The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Smoking
- Being tested
- Bupropion HCl ER, Placebo
- Keywords
- Acute coronary syndrome, Myocardial infarction, Smoking cessation, Zyban, Secondary intervention post-ACS
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion HCl ERDrug
Also called Zyban
150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Half of patients will receive placebo for 9 weeks. Receives: Drug: Placebo |
| A | Active comparator | Half of patients will receive bupropion for 9 weeks. Receives: Drug: Bupropion HCl ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.
The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.
Measured: 12 months
Secondary outcomes (1)
Composite Major Adverse Cardiovascular Events (MACE)
All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.
Composite MACE (death, myocardial infarction, unstable angina)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startDec 2005
- Primary completionJun 2010
- Study completionJun 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 (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Eisenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor-investigator, Mark Eisenberg, McGill University
- Investigators
- Mark J Eisenberg, MD, MPH, Principal investigator, Jewish General Hospital/ McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689611
- Sponsor's protocol ID
- ZESCA 9197
- Other IDs
- ISRCTN75356261
- Acronym
- ZESCA
- Status last verified
- Apr 2015
- First submitted
- 30 May 2008
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2.
PubMed 33687070Zhang DD, Eisenberg MJ, Grandi SM, Joseph L, O'Loughlin J, Paradis G, Lozano P, Filion KB. Bupropion, smoking cessation, and health-related quality of life following an acute myocardial infarction. J Popul Ther Clin Pharmacol. 2014;21(3):e346-56. Epub 2014 Oct 8.
PubMed 25326910Shimony A, Grandi SM, Pilote L, Joseph L, O'Loughlin J, Paradis G, Rinfret S, Sarrafzadegan N, Adamjee N, Yadav R, Gamra H, Diodati JG, Eisenberg MJ; ZESCA Investigators. Utilization of evidence-based therapy for acute coronary syndrome in high-income and low/middle-income countries. Am J Cardiol. 2014 Mar 1;113(5):793-7. doi: 10.1016/j.amjcard.2013.11.024. Epub 2013 Dec 12.
PubMed 24440324
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
- ClinicalTrials.gov ID
- NCT00689611
- Acronym / sponsor ID
- ZESCA / ZESCA 9197
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Smoking
- Keywords
- Acute coronary syndrome, Myocardial infarction, Smoking cessation, Zyban, Secondary intervention post-ACS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Mark EisenbergUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Study start
- Dec 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.
Detailed description
Patients who continue smoking after ACS have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an acute coronary syndrome (ACS), but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects. Bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers by approximately 50%. Although bupropion has successfully been used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown.
The ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS. The ZESCA Trial will be a multi-center effort, coordinated from the Jewish General Hospital/McGill University (Montreal, Quebec). A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site. Prior to the start of the treatment, patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation. Patients will begin treatment in-hospital and will be monitored in-hospital for ≥ 2 days prior to discharge. Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks. Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks. Prior to discharge, the patients will receive an information sheet listing the possible side effects of bupropion. They will be advised to consult the treating physician should they experience any listed side effects. While in-hospital, patients will have quit smoking and they will be instructed to not restart smoking when discharged. Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period. In addition, the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12. Smoking abstinence will be assessed at 4 weeks, 9 weeks, 6 months, and 12 months after randomization. Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide ≤ 10 ppm. Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 (by telephone calls), and weeks 4 and 9 as well as months 6 and 12 (by clinic visits). Withdrawal symptoms will also be assessed by the nurses during their weekly calls.
Trials previously conducted with bupropion involved young healthy smokers. The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: PlaceboHalf of patients will receive placebo for 9 weeks. |
| A | Active comparator | Drug: Bupropion HCl ERHalf of patients will receive bupropion for 9 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Smoke at least 10 cigarettes/day for the past year
- Suffered an enzyme-positive ACS
- Planned hospitalization of ≥24 hours
- Motivated to quit smoking
Key exclusion criteria (15 listed)
- Medical condition with a prognosis of < 1 year
- Pregnant or lactating
- Current use of Wellbutrin or any other medications that contain bupropion
- Current use of any medical therapy for smoking cessation (e.g. BuSpar, fluoxetine, doxepin, nicotine gum, or nicotine patch)
- Current seizure disorder, history of seizures or predisposition to seizures (e.g. history of brain tumor, severe head trauma, or stroke)
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 |
|---|---|---|
| Bupropion HCl ERAlso: Zyban150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks | Drug | A |
| PlaceboPlacebo | Drug | P |
Primary outcome
Smoking Abstinence
Time frame: 12 months
The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm. The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.
1 secondary outcome
Composite Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Derived from this study: PubMed 33687070Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2.
- Derived from this study: PubMed 25326910Zhang DD, Eisenberg MJ, Grandi SM, Joseph L, O'Loughlin J, Paradis G, Lozano P, Filion KB. Bupropion, smoking cessation, and health-related quality of life following an acute myocardial infarction. J Popul Ther Clin Pharmacol. 2014;21(3):e346-56. Epub 2014 Oct 8.
- Derived from this study: PubMed 24440324Shimony A, Grandi SM, Pilote L, Joseph L, O'Loughlin J, Paradis G, Rinfret S, Sarrafzadegan N, Adamjee N, Yadav R, Gamra H, Diodati JG, Eisenberg MJ; ZESCA Investigators. Utilization of evidence-based therapy for acute coronary syndrome in high-income and low/middle-income countries. Am J Cardiol. 2014 Mar 1;113(5):793-7. doi: 10.1016/j.amjcard.2013.11.024. Epub 2013 Dec 12.
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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.
Mark J Eisenberg, MD, MPH principal investigator
Jewish General Hospital/ McGill University
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupropion HCl ER in people with Acute Coronary Syndrome and Myocardial Infarction, run by Mark Eisenberg at 38 sites in 7 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 7 inclusion and 15 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Canada, United States, Bangladesh, India, Iran and 2 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 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 23 Apr 2015). 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?
Smoking Abstinence (time frame: 12 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 NCT00689611, which also lists 5 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 23 Apr 2015.