Smoking CessationPhase 3NCT00943618
Combining Varenicline and Bupropion for Smoking Cessation
A Phase 3 study testing Varenicline, Bupropion and Counseling/Phone Calls in people with Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline, Bupropion and Counseling/Phone Calls
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 641 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2010to 9 Sep 2021
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 25-70 years old
- Smoking 5 or more cigarettes per day, on average, within the 2 months preceding the screening visit and expired CO of greater than or equal to 6ppm.
- 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 home telephone number where they may be reached
- Be the only participant in their household
Who cannot join
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study.
- Within the month immediately preceding the screening visit, use of marijuana in any form on 3 or more days within a week
- Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
- Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion. Classes of contraindicated medications include, but are not limited to, antiasthmatics, antipsychotics, some antidepressants, antihypertensives, antiarrhythmics, antineoplastics, some antiseizures, and MAO inhibitors (See Appendix U for specific list of excluded and precautionary medications).
- Uncontrolled hypertension (average reading of systolic blood pressure greater than 150 or diastolic blood pressure greater than 95) or other major contraindications for Bupropion or Varenicline (See section on Screening).
- Severe renal impairment (Creatinine Clearance less than 30 ml/min/1.73 m2).
Show all 17Show fewer
- Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator.
- Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI plus (major depressive episode) and the MINI for items B, D, I, J (Alcohol Addendum-past 6 months only), K, L, M and N including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
- Individuals rated as moderate (6 - 9) to high (10 or greater) on suicidality as assessed by Module C 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.
- Use of Varenicline or Bupropion within two weeks before the screening visit.
- History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
- Current or previous history of a seizure disorder.
- Current or previous history of anorexia.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Effectiveness of Varenicline vs. Varenicline Plus Bupropion or Placebo for Smoking Cessation
The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Researchers also want to learn if this drug combination can reduce cravings and other negative symptoms of nicotine withdrawal better than varenicline does alone. The safety of this drug combination will also be tested.
Read the detailed description
The Study Drugs:
Bupropion and varenicline are designed to imitate the effects that nicotine has on the body. This may reduce cigarette cravings and help patients quit smoking.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 treatment groups.
- If you are in Group 1, you will receive varenicline and bupropion.
- If you are in Group 2, you will receive varenicline and a placebo. A placebo is a substance that looks like the study drug (in this case, bupropion) but that has no active ingredients.
- If you are in Group 3, you will receive a placebo that looks like varenicline and a placebo that looks like bupropion.
You will have a higher chance (5 out of 6) of receiving study drug than receiving just placebo. Equal numbers of patients will be in Groups 1 and 2. Neither you nor the study doctor will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.
Study Drug Administration:
You will begin taking the study drugs/placebo 1 to 10 days after the first study visit. A dose of the study drug/placebo combination will be made up of 1 tablet of varenicline or placebo and 1 tablet of bupropion or placebo. You should take each dose of study drugs/placebo with a cup (8 oz.) of water after eating a full meal.
On Days 1-3, you will take 1 dose of the study drug/placebo combination in the morning.
Beginning on Day 4, and then every day after that, you will take 1 dose in the morning and 1 dose in the evening (for a total of 2 doses of the study drug/placebo combination each day). You must return any study drug bottles as well as any unused study drug to a study staff member at each study visit.
You will be given a smoking diary to record how many cigarettes you smoke (if any) each day while you are on study. You must turn in this diary at each study visit.
Study Visits:
About 1 time each week while you are taking the study drugs/placebo, the following tests and procedures will be performed:
- Your weight and blood pressure will be measured.
- Your CO level will be measured.
- You will be asked about any other drugs you may be taking and about any side effects you may be having.
- You will answer 8 questionnaires about several topics, including depression, suicide, your smoking behavior, any effects from the study drugs, and any symptoms of attention-deficit hyperactivity disorder (ADHD). These should take about 30-45 minutes total to complete.
- You will do tasks that will measure your logic and attention. These will take about 15 -20 minutes to complete.
- You will receive counseling about quitting smoking in which you discuss possible "triggers" for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each time.
During counseling at the first study visit, you will set a "quit date" for stopping smoking for about 1 week after you start taking the study drug. You should not quit smoking before the quit date. You should stay smoke-free after the quit date. Additionally, you will be given a medication instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling.
At Week 2, saliva will be collected to check your cotinine level.
At Week 4, blood (about 2 teaspoons) will be drawn to assess liver and kidney function.
Lab Sessions:
You may be asked to take part in lab sessions during Visits 1, 2, and 6 to test your brain activity and attention span. You will be asked to watch slides and listen to a series of tones. The slides will include pictures of people, nature, and artwork. Slides showing nude people, medical procedures, and victims of car crashes will also be shown. You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study.
During the lab sessions, your brain electrical activity (EEG) will be monitored. To do this, small sensors will be placed on your scalp and face. You should not drink more than 2 cups of coffee or other caffeinated drinks for at least 2.5 hours before each session. At the first lab session, you may be asked to smoke a cigarette if the doctor thinks it is needed for you to exhibit your normal smoking behavior.
Length of Study:
You will receive the study drug for up to 12 weeks. However, the entire length of the study is about 13 months (55 weeks), which includes 3, 6, and 12-month post-quit follow up visits. You will be taken off study if the doctor thinks it is in your best interest.
End-of-Study Visit:
After you have finished taking the study drugs/placebo, the following tests and procedures will be performed:
- Your weight and blood pressure will be measured.
- Your CO level will be measured.
- You will be asked about any side effects you may be having and about any other drugs you may be taking.
- Blood (about 2 teaspoons) will be drawn to assess liver and kidney function.
- You will answer the same questionnaires you completed at the regular study visits. These should take about 30-45 minutes total to complete.
- Saliva will be collected to measure your cotinine level.
Follow-Up Visits:
About 3, 6, and 12 months after you have stopped smoking, the following tests and procedures will be performed:
- Your weight, heart rate, and blood pressure will be measured.
- Your CO level will be measured.
- You will be asked about any side effects you may be having and about any other drugs you may be taking.
- You will answer the same questionnaires you completed at the regular study visits. These should take about 30-45 minutes total to complete.
- Saliva will be collected to measure your cotinine level.
You will be called by the study staff 1 day before your quit date, 3 days after your quit date, and at Weeks 14, 20, 34, 42, and 48 weeks after your quit date to check on your progress in quitting smoking. Each call should take about 10-15 minutes.
This is an investigational study. Varenicline and bupropion are both FDA approved and commercially available to help people stop smoking. The use of the drugs in combination is investigational.
Up to 385 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, Bupropion, Placebo, Counseling/Phone Calls
- Keywords
- Smoking Cessation, Nicotine Withdrawal, Smoking Reduction, Varenicline, Chantix, Bupropion, Zyban
- Medical subject headings
- Smoking Cessation, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
On Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses).
BupropionDrug
Also called Zyban
On Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses).
PlaceboOther
On Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day.
Counseling/Phone CallsBehavioural
Brief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Varenicline and Bupropion Receives: Drug: Varenicline; Drug: Bupropion; Behavioral: Counseling/Phone Calls |
| Group 2 | Placebo comparator | Varenicline and Placebo Receives: Drug: Varenicline; Other: Placebo; Behavioral: Counseling/Phone Calls |
| Group 3 | Placebo comparator | Placebo that looks like varenicline and a placebo that looks like bupropion. Receives: Other: Placebo; Behavioral: Counseling/Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence at 12 Months
Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date.
Measured: From quit date to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study start17 May 2010
- Primary completion31 May 2020
- Study completion9 Sep 2021
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Pfizer
- Responsible party
- Sponsor
- Investigators
- Paul M Cinciripini, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943618
- Sponsor's protocol ID
- 2008-0850
- Other IDs
- R01DA024709-01A1, NCI-2011-01101
- Status last verified
- Apr 2025
- First submitted
- 20 Jul 2009
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cinciripini PM, Minnix JA, Green CE, Robinson JD, Engelmann JM, Versace F, Wetter DW, Shete S, Karam-Hage M. An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use. Addiction. 2018 Apr 21:10.1111/add.14250. doi: 10.1111/add.14250. Online ahead of print.
PubMed 29679432Hartmann-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 34611902
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Varenicline vs. Varenicline Plus Bupropion or Placebo for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00943618
- Acronym / sponsor ID
- 2008-0850
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Nicotine Withdrawal, Smoking Reduction, Varenicline, Chantix, Bupropion, Zyban
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Pfizer
- Study start
- 17 May 2010 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Researchers also want to learn if this drug combination can reduce cravings and other negative symptoms of nicotine withdrawal better than varenicline does alone. The safety of this drug combination will also be tested.
Detailed description
The Study Drugs:
Bupropion and varenicline are designed to imitate the effects that nicotine has on the body. This may reduce cigarette cravings and help patients quit smoking.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 treatment groups.
- If you are in Group 1, you will receive varenicline and bupropion.
- If you are in Group 2, you will receive varenicline and a placebo. A placebo is a substance that looks like the study drug (in this case, bupropion) but that has no active ingredients.
- If you are in Group 3, you will receive a placebo that looks like varenicline and a placebo that looks like bupropion.
You will have a higher chance (5 out of 6) of receiving study drug than receiving just placebo. Equal numbers of patients will be in Groups 1 and 2. Neither you nor the study doctor will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.
Study Drug Administration:
You will begin taking the study drugs/placebo 1 to 10 days after the first study visit. A dose of the study drug/placebo combination will be made up of 1 tablet of varenicline or placebo and 1 tablet of bupropion or placebo. You should take each dose of study drugs/placebo with a cup (8 oz.) of water after eating a full meal.
On Days 1-3, you will take 1 dose of the study drug/placebo combination in the morning.
Beginning on Day 4, and then every day after that, you will take 1 dose in the morning and 1 dose in the evening (for a total of 2 doses of the study drug/placebo combination each day). You must return any study drug bottles as well as any unused study drug to a study staff member at each study visit.
You will be given a smoking diary to record how many cigarettes you smoke (if any) each day while you are on study. You must turn in this diary at each study visit.
Study Visits:
About 1 time each week while you are taking the study drugs/placebo, the following tests and procedures will be performed:
- Your weight and blood pressure will be measured.
- Your CO level will be measured.
- You will be asked about any other drugs you may be taking and about any side effects you may be having.
- You will answer 8 questionnaires about several topics, including depression, suicide, your smoking behavior, any effects from the study drugs, and any symptoms of attention-deficit hyperactivity disorder (ADHD). These should take about 30-45 minutes total to complete.
- You will do tasks that will measure your logic and attention. These will take about 15 -20 minutes to complete.
- You will receive counseling about quitting smoking in which you discuss possible "triggers" for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each time.
During counseling at the first study visit, you will set a "quit date" for stopping smoking for about 1 week after you start taking the study drug. You should not quit smoking before the quit date. You should stay smoke-free after the quit date. Additionally, you will be given a medication instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling.
At Week 2, saliva will be collected to check your cotinine level.
At Week 4, blood (about 2 teaspoons) will be drawn to assess liver and kidney function.
Lab Sessions:
You may be asked to take part in lab sessions during Visits 1, 2, and 6 to test your brain activity and attention span. You will be asked to watch slides and listen to a series of tones. The slides will include pictures of people, nature, and artwork. Slides showing nude people, medical procedures, and victims of car crashes will also be shown. You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study.
During the lab sessions, your brain electrical activity (EEG) will be monitored. To do this, small sensors will be placed on your scalp and face. You should not drink more than 2 cups of coffee or other caffeinated drinks for at least 2.5 hours before each session. At the first lab session, you may be asked to smoke a cigarette if the doctor thinks it is needed for you to exhibit your normal smoking behavior.
Length of Study:
You will receive the study drug for up to 12 weeks. However, the entire length of the study is about 13 months (55 weeks), which includes 3, 6, and 12-month post-quit follow up visits. You will be taken off study if the doctor thinks it is in your best interest.
End-of-Study Visit:
After you have finished taking the study drugs/placebo, the following tests and procedures will be performed:
- Your weight and blood pressure will be measured.
- Your CO level will be measured.
- You will be asked about any side effects you may be having and about any other drugs you may be taking.
- Blood (about 2 teaspoons) will be drawn to assess liver and kidney function.
- You will answer the same questionnaires you completed at the regular study visits. These should take about 30-45 minutes total to complete.
- Saliva will be collected to measure your cotinine level.
Follow-Up Visits:
About 3, 6, and 12 months after you have stopped smoking, the following tests and procedures will be performed:
- Your weight, heart rate, and blood pressure will be measured.
- Your CO level will be measured.
- You will be asked about any side effects you may be having and about any other drugs you may be taking.
- You will answer the same questionnaires you completed at the regular study visits. These should take about 30-45 minutes total to complete.
- Saliva will be collected to measure your cotinine level.
You will be called by the study staff 1 day before your quit date, 3 days after your quit date, and at Weeks 14, 20, 34, 42, and 48 weeks after your quit date to check on your progress in quitting smoking. Each call should take about 10-15 minutes.
This is an investigational study. Varenicline and bupropion are both FDA approved and commercially available to help people stop smoking. The use of the drugs in combination is investigational.
Up to 385 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Varenicline, Drug: Bupropion, Behavioral: Counseling/Phone CallsVarenicline and Bupropion |
| Group 2 | Placebo comparator | Drug: Varenicline, Other: Placebo, Behavioral: Counseling/Phone CallsVarenicline and Placebo |
| Group 3 | Placebo comparator | Other: Placebo, Behavioral: Counseling/Phone CallsPlacebo that looks like varenicline and a placebo that looks like bupropion. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 25-70 years old
- Smoking 5 or more cigarettes per day, on average, within the 2 months preceding the screening visit and expired CO of greater than or equal to 6ppm.
- 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 home telephone number where they may be reached
Key exclusion criteria (17 listed)
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study.
- Within the month immediately preceding the screening visit, use of marijuana in any form on 3 or more days within a week
- Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
- Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion. Classes of contraindicated medications include, but are not limited to, antiasthmatics, antipsychotics, some antidepressants, antihypertensives, antiarrhythmics, antineoplastics, some antiseizures, and MAO inhibitors (See Appendix U for specific list of excluded and precautionary medications).
- Uncontrolled hypertension (average reading of systolic blood pressure greater than 150 or diastolic blood pressure greater than 95) or other major contraindications for Bupropion or Varenicline (See section on Screening).
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: ChantixOn Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses). | Drug | Group 1, Group 2 |
| BupropionAlso: ZybanOn Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses). | Drug | Group 1 |
| PlaceboOn Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day. | Other | Group 2, Group 3 |
| Counseling/Phone CallsBrief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date. | Behavioural | Group 1, Group 2, Group 3 |
Primary outcome
Smoking Abstinence at 12 Months
Time frame: From quit date to 12 months.
Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29679432Cinciripini PM, Minnix JA, Green CE, Robinson JD, Engelmann JM, Versace F, Wetter DW, Shete S, Karam-Hage M. An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use. Addiction. 2018 Apr 21:10.1111/add.14250. doi: 10.1111/add.14250. Online ahead of print.
- 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.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Paul M Cinciripini, PhD 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 3 study testing Varenicline, Bupropion and Counseling/Phone Calls in people with Smoking Cessation, 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 17 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 4 May 2025. 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 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 8 Jul 2021). 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 at 12 Months (time frame: From quit date to 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 NCT00943618, 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 4 May 2025.