Cigarette SmokerPhase 4NCT02271919
Varenicline and Combined NRT for Smoking Cessation
A Phase 4 study testing Nicotine Lozenge, Nicotine Patch and Tobacco Cessation Counseling in people with Cigarette Smoker and Tobacco Use Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Tobacco Use Disorder
- What is being tested?
- Nicotine Lozenge, Nicotine Patch and Tobacco Cessation Counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 631 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2015to 1 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then positive cotinine test)
- Interested in treatment that might change smoking behavior
- Able to follow verbal and written instructions in English and complete all aspects of the study
- Provide informed consent and agree to all assessments and study procedures
- Have an address and telephone number where he/she may be reached
- Be the only participant in his/her household
Who cannot join
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars and/or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
- Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
- Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
- Uncontrolled hypertension (systolic blood pressure; [SBP] greater than 180 or diastolic blood pressure; [DBP] greater than 110)
- History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level
- Laboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigator
Show all 18Show fewer
- Serious or unstable disease within the past 3 months
- History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
- Current use of certain medications: (1) smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (Amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month's duration)
- Meet criteria for the following psychiatric and/or substance use disorders as assessed by the MINI International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum - past 6 months only; current alcohol dependence), J (substance abuse - Substance Abuse Addendum - past 6 months only; current substance dependence), K (current/lifetime psychotic disorder or current/lifetime mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator and/or study physician
- Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI
- Psychiatric hospitalization within 1 year of screening date
- A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
- Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
- History of hypersensitivity or allergic reaction to varenicline, NRT, or any component of these formulations
- Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
- Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or tetrahydrocannabinol (THC); a. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; b. participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return; study physician may clear participant to continue on if there is a reasonable possibility the positive drug screen is the result of cross-reactivity with the participant's concomitant medications resulting in a false positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial
This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.
Read the detailed description
Primary Objectives: To estimate (a) the effects at 12 weeks of either continuing on their current medication, switching to the other medication, or increasing the dose of their current medication among smokers initially treated with either varenicline 2 mg (VAR) or nicotine patch + ad lib lozenge (combined nicotine replacement therapy; CNRT) but who relapsed to smoking by week 6 of treatment, and (b) the effects of 12 weeks of continued treatment on either VAR or CNRT among individuals who are abstinent from smoking at 6 weeks.
OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to CNRT, or receiving high-dose varenicline. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
GROUP II: Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to varenicline, or receiving high-dose CNRT. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
- Conditions
- Cigarette Smoker, Tobacco Use Disorder
- Being tested
- Nicotine Lozenge, Nicotine Patch, Placebo, Tobacco Cessation Counseling, Varenicline
- 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 LozengeDrug
Also called Commit
Given PO
Nicotine PatchDrug
Also called NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Given via patch
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO or via patch
Tobacco Cessation CounselingOther
Receive behavioral smoking cessation counseling
VareniclineDrug
Also called Champix, Chantix, CP-526555
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (varenicline and placebo) | Experimental | Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to CNRT, or receiving high-dose varenicline. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment. Receives: Drug: Nicotine Lozenge; Drug: Nicotine Patch; Other: Placebo; Other: Tobacco Cessation Counseling; Drug: Varenicline |
| Group II (placebo, nicotine patch and lozenge) | Placebo comparator | Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to varenicline, or receiving high-dose CNRT. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment. Receives: Drug: Nicotine Lozenge; Drug: Nicotine Patch; Other: Placebo; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
7-day point-prevalence smoking abstinence (i.e., no self-reported smoking in the past 7 days), verified by expired carbon monoxide <6 ppm (parts per millions)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start14 May 2015
- Primary completion30 Jun 2025
- Study completion1 Apr 2026
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 Cigarette SmokerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jason Robinson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271919
- Sponsor's protocol ID
- 2014-0213
- Other IDs
- NCI-2015-00610, 2014-0213
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2014
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cinciripini PM, Green CE, Shete S, Minnix JA, Robinson JD, Cui Y, Kim S, Kypriotakis G, Beneventi D, Blalock JA, Versace F, Karam-Hage M. Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial. JAMA. 2024 May 28;331(20):1722-1731. doi: 10.1001/jama.2024.4183.
PubMed 38696203Livingstone-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 37142273
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT02271919
- Acronym / sponsor ID
- 2014-0213
- Conditions
- Cigarette Smoker, Tobacco Use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 May 2015 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.
Detailed description
Primary Objectives: To estimate (a) the effects at 12 weeks of either continuing on their current medication, switching to the other medication, or increasing the dose of their current medication among smokers initially treated with either varenicline 2 mg (VAR) or nicotine patch + ad lib lozenge (combined nicotine replacement therapy; CNRT) but who relapsed to smoking by week 6 of treatment, and (b) the effects of 12 weeks of continued treatment on either VAR or CNRT among individuals who are abstinent from smoking at 6 weeks.
OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to CNRT, or receiving high-dose varenicline. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
GROUP II: Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to varenicline, or receiving high-dose CNRT. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (varenicline and placebo) | Experimental | Drug: Nicotine Lozenge, Drug: Nicotine Patch, Other: Placebo, Other: Tobacco Cessation Counseling, Drug: VareniclinePatients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to CNRT, or receiving high-dose varenicline. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment. |
| Group II (placebo, nicotine patch and lozenge) | Placebo comparator | Drug: Nicotine Lozenge, Drug: Nicotine Patch, Other: Placebo, Other: Tobacco Cessation CounselingPatients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to varenicline, or receiving high-dose CNRT. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then positive cotinine test)
- Interested in treatment that might change smoking behavior
- Able to follow verbal and written instructions in English and complete all aspects of the study
- Provide informed consent and agree to all assessments and study procedures
- Have an address and telephone number where he/she may be reached
Key exclusion criteria (18 listed)
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars and/or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
- Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
- Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
- Uncontrolled hypertension (systolic blood pressure; [SBP] greater than 180 or diastolic blood pressure; [DBP] greater than 110)
- History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level
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 LozengeAlso: CommitGiven PO | Drug | Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) |
| Nicotine PatchAlso: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal PatchGiven via patch | Drug | Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO or via patch | Other | Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) |
| Tobacco Cessation CounselingReceive behavioral smoking cessation counseling | Other | Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) |
| VareniclineAlso: Champix, Chantix, CP-526555Given PO | Drug | Group I (varenicline and placebo) |
Primary outcome
Smoking Abstinence
Time frame: 12 weeks
7-day point-prevalence smoking abstinence (i.e., no self-reported smoking in the past 7 days), verified by expired carbon monoxide <6 ppm (parts per millions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38696203Cinciripini PM, Green CE, Shete S, Minnix JA, Robinson JD, Cui Y, Kim S, Kypriotakis G, Beneventi D, Blalock JA, Versace F, Karam-Hage M. Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial. JAMA. 2024 May 28;331(20):1722-1731. doi: 10.1001/jama.2024.4183.
- 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.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Cigarette Smoker
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial
Lung Carcinoma
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
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.
Jason Robinson principal investigator
M.D. Anderson Cancer Center
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 Lozenge, Nicotine Patch and Tobacco Cessation Counseling in people with Cigarette Smoker and Tobacco Use Disorder, run by M.D. Anderson Cancer Center 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 6 inclusion and 18 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 24 Apr 2026. 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. 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 24 Apr 2026). 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 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 NCT02271919, 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 24 Apr 2026.