Smoking CessationPhase 4NCT02859142
Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
A Phase 4 study testing Chantix, Behavioral Counseling Sessions and NicodermCQ in people with Smoking Cessation and Alcohol Drinking, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Alcohol Drinking
- What is being tested?
- Chantix, Behavioral Counseling Sessions and NicodermCQ
- 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
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 15 Oct 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoke 3-30 cigarettes/day
- Desire to quit smoking as indicated on a smoking stages ladder
- Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12 oz beer, 5 oz wine, 1.5 oz liquor)
- Ability to understand, read, and write in English, at least 8th grade education
- Willing and able to sign an informed consent
- Stable residence and contact information.
Who cannot join
- Hepatic panel indices > 2 SD
- History of seizures or DTs during alcohol withdrawal
- Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations, severe depression, obsessional thinking, self-injury risking significant blood loss, etc.) deemed by the study physician to be at significant risk for adverse interactions with study medications or measures.
- History of adverse reactions to varenicline (VAR) or nicotine patch
- Current suicidal ideation (past 6 months) and/or history of major suicide attempts.
- For women of child-bearing potential: currently pregnant, lactating, current plans to become pregnant in next three months, or unable to agree to adequate birth control during study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Addictions Research Laboratory
Chicago, Illinois, 60637
About this study
The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.
Read the detailed description
This study will conduct a real-world clinic-based smoking cessation trial examining the augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral counseling versus standard treatment of patch plus behavioral counseling only in heavy drinkers who smoke (HDS). While Chantix is approved for smoking cessation, it is not routinely given in practice for HDS patients
In this study, there will be 4 total in-person study visits over the trial (pre-quit, quit date, week 2 and week 12), ending 12 weeks after the quit date. Biochemical verification from breath tests for CO, as well as vital signs and weight, will be measured at each visit along with survey responses measuring smoking urge and withdrawal, negative affect, neurocognition, and alcohol and smoking behaviors. These will also be used at a 26-week follow-up by telephone with biochemical verification for CO in those reporting being smoke-free.
Screening and Randomization Participants will respond to advertisements and will undergo a brief phone screening to determine initial eligibility requirements. Qualified candidates will be invited into the lab to conduct a short screening and study information session at the Clinical Addictions Research Laboratory at the University of Chicago. At screening, participants will sign an informed consent document. Next, demographics, smoking, alcohol and substance use patterns, health history, medications, vital signs, a urine test (for pregnancy and/or drug toxicology) and a blood test will be obtained.
Eligible participants will be randomized into one of two treatment groups: Standard Treatment (w/ placebo) will proceed with the study receiving nicotine patches and brief counseling sessions; Augmented Treatment will proceed with the same nicotine patches and brief counseling sessions, but will also receive standard dosing of Chantix (Varenicline tartrate).
Nicotine Patches Nicotine patches will be utilized starting at study quit date, and proceed according to package insert directions (10+ cigs/day smokers will begin with 21mg patches for six weeks, followed by 14mg patches for four weeks, and finally 7mg patches for two weeks. Those smoking fewer than 10 cigarettes/day will follow the same process starting at the 14mg patch level.
Chantix (Varenicline Tartrate) Those receiving Augmented Treatment will receive varenicline. They will undergo an up-titration week prior to the quit date, 12 weeks of target dosing, and a down-titration week. As per Pfizer recommendations, up-titration will be 0.5mg tablets once daily for 3 days followed by twice daily for four days leading to the quit date on day 8. The sequence will reverse for a down-titration week on week 13.
Placebo for Varenicline Those receiving standard treatment will also receive placebo medication that will be identical in appearance to and follow the same distribution protocol as varenicline.
Smoking Cessation Behavioral Sessions:
Participants will attend one-on-one behavioral counseling sessions with a trained Masters or PhD. Level therapist at each study visit. Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. At each study visit, subjective measures (i.e. brief self-report surveys about
Follow-Up Interview (Week 26) At Study Week 26, participants will complete a follow-up telephone interview, completing similar subjective measures as those completed during study visits. Participants reporting being smoke-free during this interview will arrange for biochemical verification of this status via expired CO testing either by arranging for a time to stop into one of the study sites or by arranging for study staff to meet with them in their home or workplace.
- Conditions
- Smoking Cessation, Alcohol Drinking
- Being tested
- Chantix, Behavioral Counseling Sessions, NicodermCQ, Placebo
- Keywords
- Varenicline
- Medical subject headings
- Smoking Cessation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChantixDrug
Also called Varenicline Tartrate
Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
Behavioral Counseling SessionsBehavioural
One-to-one behavioral counseling sessions with a trained therapist
NicodermCQDrug
Also called Transdermal Nicotine Patch
Nicotine patches provided over 12 week participation
PlaceboDrug
Identical in appearance to varenicline [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
| Study group | Role | What they receive |
|---|---|---|
| Augmented Treatment | Experimental | Participants receive 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.
* Chantix (Varenicline) and NicodermCQ (Nicotine Patches): Administered according to package insert directions
* Behavioral Counseling Sessions: Participants will attend one-on-one behavioral counseling sessions with a trained therapist at each of 4 study visits (pre-quit, quit date, week 2, and week 12). Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. Receives: Drug: Chantix; Behavioral: Behavioral Counseling Sessions; Drug: NicodermCQ |
| Standard Treatment w/ placebo | Active comparator | Participants receive 12 weeks of standard smoking cessation treatment of nicotine patches and behavioral counseling visits in addition to placebo pills identical in appearance to varenicline
* Placebo pills (identical to varenicline)
* NicodermCQ (Nicotine Patches): Administered according to package insert directions
* Behavioral Counseling Sessions: Participants will attend one-on-one behavioral counseling sessions with a trained therapist at each of 4 study visits (pre-quit, quit date, week 2, and week 12). Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. Receives: Behavioral: Behavioral Counseling Sessions; Drug: NicodermCQ; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Smoking Abstinence Rates at 12 Weeks
Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.
Measured: 12 weeks
Secondary outcomes (5)
Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks
Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks
Measured: 12 weeks
Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks
Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks
Measured: 26 weeks
Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks
Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 12 weeks
Measured: 12 weeks
Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks
Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 26 weeks
Measured: 26 weeks
Change From Baseline Smoking Abstinence Rates at 26 Weeks
Number of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start29 Mar 2018
- Primary completion30 Sep 2020
- Study completion15 Oct 2020
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 (8)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 University of ChicagoThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrea King, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859142
- Sponsor's protocol ID
- 15-1615
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2016
- Last updated
- 27 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coe JW, Brooks PR, Vetelino MG, Wirtz MC, Arnold EP, Huang J, Sands SB, Davis TI, Lebel LA, Fox CB, Shrikhande A, Heym JH, Schaeffer E, Rollema H, Lu Y, Mansbach RS, Chambers LK, Rovetti CC, Schulz DW, Tingley FD 3rd, O'Neill BT. Varenicline: an alpha4beta2 nicotinic receptor partial agonist for smoking cessation. J Med Chem. 2005 May 19;48(10):3474-7. doi: 10.1021/jm050069n.
PubMed 15887955Perkins KA, Mercincavage M, Fonte CA, Lerman C. Varenicline's effects on acute smoking behavior and reward and their association with subsequent abstinence. Psychopharmacology (Berl). 2010 May;210(1):45-51. doi: 10.1007/s00213-010-1816-9. Epub 2010 Mar 20.
PubMed 20306175Tapper AR, McKinney SL, Nashmi R, Schwarz J, Deshpande P, Labarca C, Whiteaker P, Marks MJ, Collins AC, Lester HA. Nicotine activation of alpha4* receptors: sufficient for reward, tolerance, and sensitization. Science. 2004 Nov 5;306(5698):1029-32. doi: 10.1126/science.1099420.
PubMed 15528443Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
PubMed 16820547Koegelenberg CF, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O'Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen TM, Irusen EM. Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014 Jul;312(2):155-61. doi: 10.1001/jama.2014.7195.
PubMed 25005652Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569King A, Vena A, de Wit H, Grant JE, Cao D. Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220951. doi: 10.1001/jamanetworkopen.2022.0951.
PubMed 35244704Hartmann-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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
- ClinicalTrials.gov ID
- NCT02859142
- Acronym / sponsor ID
- 15-1615
- Conditions
- Smoking Cessation, Alcohol Drinking
- Keywords
- Varenicline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 27 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.
Detailed description
This study will conduct a real-world clinic-based smoking cessation trial examining the augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral counseling versus standard treatment of patch plus behavioral counseling only in heavy drinkers who smoke (HDS). While Chantix is approved for smoking cessation, it is not routinely given in practice for HDS patients
In this study, there will be 4 total in-person study visits over the trial (pre-quit, quit date, week 2 and week 12), ending 12 weeks after the quit date. Biochemical verification from breath tests for CO, as well as vital signs and weight, will be measured at each visit along with survey responses measuring smoking urge and withdrawal, negative affect, neurocognition, and alcohol and smoking behaviors. These will also be used at a 26-week follow-up by telephone with biochemical verification for CO in those reporting being smoke-free.
Screening and Randomization Participants will respond to advertisements and will undergo a brief phone screening to determine initial eligibility requirements. Qualified candidates will be invited into the lab to conduct a short screening and study information session at the Clinical Addictions Research Laboratory at the University of Chicago. At screening, participants will sign an informed consent document. Next, demographics, smoking, alcohol and substance use patterns, health history, medications, vital signs, a urine test (for pregnancy and/or drug toxicology) and a blood test will be obtained.
Eligible participants will be randomized into one of two treatment groups: Standard Treatment (w/ placebo) will proceed with the study receiving nicotine patches and brief counseling sessions; Augmented Treatment will proceed with the same nicotine patches and brief counseling sessions, but will also receive standard dosing of Chantix (Varenicline tartrate).
Nicotine Patches Nicotine patches will be utilized starting at study quit date, and proceed according to package insert directions (10+ cigs/day smokers will begin with 21mg patches for six weeks, followed by 14mg patches for four weeks, and finally 7mg patches for two weeks. Those smoking fewer than 10 cigarettes/day will follow the same process starting at the 14mg patch level.
Chantix (Varenicline Tartrate) Those receiving Augmented Treatment will receive varenicline. They will undergo an up-titration week prior to the quit date, 12 weeks of target dosing, and a down-titration week. As per Pfizer recommendations, up-titration will be 0.5mg tablets once daily for 3 days followed by twice daily for four days leading to the quit date on day 8. The sequence will reverse for a down-titration week on week 13.
Placebo for Varenicline Those receiving standard treatment will also receive placebo medication that will be identical in appearance to and follow the same distribution protocol as varenicline.
Smoking Cessation Behavioral Sessions:
Participants will attend one-on-one behavioral counseling sessions with a trained Masters or PhD. Level therapist at each study visit. Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. At each study visit, subjective measures (i.e. brief self-report surveys about
Follow-Up Interview (Week 26) At Study Week 26, participants will complete a follow-up telephone interview, completing similar subjective measures as those completed during study visits. Participants reporting being smoke-free during this interview will arrange for biochemical verification of this status via expired CO testing either by arranging for a time to stop into one of the study sites or by arranging for study staff to meet with them in their home or workplace.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Treatment | Experimental | Drug: Chantix, Behavioral: Behavioral Counseling Sessions, Drug: NicodermCQParticipants receive 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits. * Chantix (Varenicline) and NicodermCQ (Nicotine Patches): Administered according to package insert directions * Behavioral Counseling Sessions: Participants will attend one-on-one behavioral counseling sessions with a trained therapist at each of 4 study visits (pre-quit, quit date, week 2, and week 12). Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. |
| Standard Treatment w/ placebo | Active comparator | Behavioral: Behavioral Counseling Sessions, Drug: NicodermCQ, Drug: PlaceboParticipants receive 12 weeks of standard smoking cessation treatment of nicotine patches and behavioral counseling visits in addition to placebo pills identical in appearance to varenicline * Placebo pills (identical to varenicline) * NicodermCQ (Nicotine Patches): Administered according to package insert directions * Behavioral Counseling Sessions: Participants will attend one-on-one behavioral counseling sessions with a trained therapist at each of 4 study visits (pre-quit, quit date, week 2, and week 12). Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoke 3-30 cigarettes/day
- Desire to quit smoking as indicated on a smoking stages ladder
- Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12 oz beer, 5 oz wine, 1.5 oz liquor)
- Ability to understand, read, and write in English, at least 8th grade education
- Willing and able to sign an informed consent
Key exclusion criteria (6 listed)
- Hepatic panel indices > 2 SD
- History of seizures or DTs during alcohol withdrawal
- Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations, severe depression, obsessional thinking, self-injury risking significant blood loss, etc.) deemed by the study physician to be at significant risk for adverse interactions with study medications or measures.
- History of adverse reactions to varenicline (VAR) or nicotine patch
- Current suicidal ideation (past 6 months) and/or history of major suicide attempts.
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 |
|---|---|---|
| ChantixAlso: Varenicline TartrateChantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day] | Drug | Augmented Treatment |
| Behavioral Counseling SessionsOne-to-one behavioral counseling sessions with a trained therapist | Behavioural | Augmented Treatment, Standard Treatment w/ placebo |
| NicodermCQAlso: Transdermal Nicotine PatchNicotine patches provided over 12 week participation | Drug | Augmented Treatment, Standard Treatment w/ placebo |
| PlaceboIdentical in appearance to varenicline [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day] | Drug | Standard Treatment w/ placebo |
Primary outcome
Change From Baseline Smoking Abstinence Rates at 12 Weeks
Time frame: 12 weeks
Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.
5 secondary outcomes
Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks
Time frame: 12 weeks
Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks
Time frame: 26 weeks
Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks
Time frame: 12 weeks
Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks
Time frame: 26 weeks
Change From Baseline Smoking Abstinence Rates at 26 Weeks
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15887955Coe JW, Brooks PR, Vetelino MG, Wirtz MC, Arnold EP, Huang J, Sands SB, Davis TI, Lebel LA, Fox CB, Shrikhande A, Heym JH, Schaeffer E, Rollema H, Lu Y, Mansbach RS, Chambers LK, Rovetti CC, Schulz DW, Tingley FD 3rd, O'Neill BT. Varenicline: an alpha4beta2 nicotinic receptor partial agonist for smoking cessation. J Med Chem. 2005 May 19;48(10):3474-7. doi: 10.1021/jm050069n.
- Background: PubMed 20306175Perkins KA, Mercincavage M, Fonte CA, Lerman C. Varenicline's effects on acute smoking behavior and reward and their association with subsequent abstinence. Psychopharmacology (Berl). 2010 May;210(1):45-51. doi: 10.1007/s00213-010-1816-9. Epub 2010 Mar 20.
- Background: PubMed 15528443Tapper AR, McKinney SL, Nashmi R, Schwarz J, Deshpande P, Labarca C, Whiteaker P, Marks MJ, Collins AC, Lester HA. Nicotine activation of alpha4* receptors: sufficient for reward, tolerance, and sensitization. Science. 2004 Nov 5;306(5698):1029-32. doi: 10.1126/science.1099420.
- Background: PubMed 16820547Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
- Background: PubMed 25005652Koegelenberg CF, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O'Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen TM, Irusen EM. Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014 Jul;312(2):155-61. doi: 10.1001/jama.2014.7195.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 35244704King A, Vena A, de Wit H, Grant JE, Cao D. Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220951. doi: 10.1001/jamanetworkopen.2022.0951.
- 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.
- Individual participant dataSharing planned: No
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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.
Andrea King, Ph.D. principal investigator
University of Chicago
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 Chantix, Behavioral Counseling Sessions and NicodermCQ in people with Smoking Cessation and Alcohol Drinking, run by University of Chicago 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 6 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 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?
Change From Baseline Smoking Abstinence Rates at 12 Weeks (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 NCT02859142, which also lists 8 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 27 Sep 2021.