Tobacco DependencePhase 4QUITSNCT03176784
UW Quitting Using Intensive Treatment Study (QUITS)
A Phase 4 study testing Varenicline and Nicotine patch in people with Tobacco Dependence, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Varenicline and Nicotine patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,251 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Nov 2017to 9 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must: plan to stay in the area for the next 12 months, ability to read and write in English, smoke on average ≥5 cigarettes per day over the last 6 months, be ≥18 years old, desire to quit smoking but not be engaged currently in cessation treatment, report no use of pipe tobacco, cigars, snuff, e-cigarettes or chew in the last 30 days, have reliable phone access, willing and able to use both nicotine patch and varenicline, access to transportation to come to our clinic and, if female, not be pregnant and be using an acceptable birth control method/ method to prevent pregnancy. Smoking will be biochemically confirmed via a carbon monoxide (CO) breath test at the orientation session visit. Potential participants must have a CO test result of ≥5ppm for eligibility to participate.
Who cannot join
- Current treatment for schizophrenia or a psychotic disorder; suicidal ideation in the past 12 months; history of suicidal attempts within the last 10 years; on dialysis or being told you have severe kidney disease; hospitalization for a stroke, heart attack, congestive heart failure or uncontrolled diabetes mellitus within the past year; history of seizure within the last year; currently taking Wellbutrin, Zyban, or Buproprion (Contrave is a weight-loss drug that has Wellbutrin in it) for reasons other than to quit smoking or taking to help quit smoking and not willing to stop for duration of the study; currently using any form of nicotine replacement (e.g., nicotine patch, nicotine gum, nicotine lozenge) or using Chantix or varenicline and not willing to stop for duration of the study; had a reaction to the nicotine patch that prevented them from continuing to use it; or currently participating in another smoking cessation study.
- Pregnancy:
- Even though we screen out participants who are pregnant, plan to become pregnant, nursing, or are unwilling to take steps to avoid pregnancy, there is a chance that a participant eligible at consent could become pregnant later. She would then be considered part of a vulnerable group. Given the longitudinal nature of the research, a participant who becomes pregnant after enrolling will be given the choice of whether to 1) continue in the study (for counseling and other assessments) and agree to immediately stop taking study meds for the remaining duration of the study and return any unused medications, OR 2) withdraw. No further medications will be given to this study participant while in the study.
- Incarcerated Individuals:
- Incarcerated individuals will not be enrolled in this study. However, given the longitudinal nature of the research, participants could be incarcerated for periods during their participation. If study staff learn that a participant is incarcerated at a time point before or at their Week 8 phone call, the participant will be withdrawn from the study. If study staff learn that a participant is incarcerated subsequent to Week 8, the participant will not be withdrawn unless that incarceration will take them beyond the study period. In that case, staff will not contact the participant while incarcerated and will not provide any treatment (counseling or medication) nor conduct any assessments during the period of incarceration. Services and assessments will be re-initiated if the participant is released at a later study time point.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UW Center For Tobacco Research and Intervention
Madison, Wisconsin, 53711
UW Center for Tobacco Research and Intervention
Milwaukee, Wisconsin, 53233
About this study
Official title: UW Quitting Using Intensive Treatment Study
This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.
Read the detailed description
Building on our recent NHLBI-funded publication in JAMA (see references below) that described the modest effectiveness of varenicline pharmacotherapy, this study will use a 2 X 2 factorial design to evaluate two different medication use strategies on their ability to markedly enhance varenicline effectiveness in a large cohort of current smokers. Smokers (N=1000) will be randomly assigned to one of two levels for each of two factors: 1) an Adjuvant factor (varenicline + placebo patch versus varenicline + nicotine patch), and 2) a Duration factor (12 versus 24 weeks of active medication). Thus, this factorial design yields a "standard" varenicline treatment (12 weeks of active varenicline and 12 weeks of placebo varenicline + 24 weeks of placebo patch), and 3 enhanced treatments: 1) 12 weeks of active varenicline and 12 weeks of placebo varenicline + 24 weeks of active patch, 2) 24-weeks of active varenicline + 24 weeks of placebo patch, and 3) 24 weeks of active varenicline + 24 weeks of active patch.
Both treatment modifications, longer duration therapy and use of a nicotine replacement therapy (NRT) adjuvant, have produced some quite promising effects. However, in both cases these modifications have been little researched, their effects are not consistently positive, and they have not been implemented in a potentially optimal manner. We will implement each modification in an innovative manner designed to enhance its effectiveness. In addition, all participants will be given counseling that supports adherent medication use and that is readily translatable to healthcare settings. The scientific rigor of this work will be enhanced by the use of placebo medication, a large sample, and a factorial design. The latter will allow us to test both the main and interaction effects of the experimental factors. We will also be able to compare each enhanced treatment with standard 12-week varenicline-only therapy to determine whether any of these medication use strategies significantly enhances treatment effectiveness.
- Conditions
- Tobacco Dependence
- Being tested
- Varenicline, Nicotine patch, Placebo Patch, Placebo Pill
- Keywords
- Varenicline, Nicotine Patch, Quit Smoking, Tobacco, Cigarettes
- 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.
VareniclineDrug
Also called Chantix
0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patchDrug
Also called Nicoderm CQ
14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo PatchOther
Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo PillOther
Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
| Study group | Role | What they receive |
|---|---|---|
| Varenicline + Patch Standard Duration | Experimental | Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24 Receives: Drug: Varenicline; Drug: Nicotine patch; Other: Placebo Patch; Other: Placebo Pill |
| Varenicline Only Standard Duration | Experimental | Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit Receives: Drug: Varenicline; Other: Placebo Patch; Other: Placebo Pill |
| Varenicline + Patch Extended Duration | Experimental | Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit. Receives: Drug: Varenicline; Drug: Nicotine patch |
| Varenicline Only Extended Duration | Experimental | Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit Receives: Drug: Varenicline; Other: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
52-Week Point-Prevalence Abstinence
Biochemically-confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Measured: Assessed 52 weeks after quit date
Secondary outcomes (3)
23-Week Point-Prevalence Abstinence
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Measured: Assessed 23 weeks after quit date
52-Week Prolonged Abstinence
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 52 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Measured: Assessed 52 weeks after quit date
23-Week Prolonged Abstinence
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 23 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Measured: Assessed 23 weeks after quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start11 Nov 2017
- Primary completion9 Jul 2020
- Study completion9 Jul 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 (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Double Blinded Placebo Controlled Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Timothy B Baker, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176784
- Sponsor's protocol ID
- 2017-0404
- Other IDs
- R01HL109031, A534253, SMPH/MEDICINE/GEN INT MD, Protocol Version 6/11/2020
- Acronym
- QUITS
- Status last verified
- Jan 2023
- First submitted
- 1 Jun 2017
- Last updated
- 23 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data set will be posted by UW-CTRI in accord with NHLBI policies
Publications
Baker TB, Piper ME, Stein JH, Smith SS, Bolt DM, Fraser DL, Fiore MC. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):371-9. doi: 10.1001/jama.2015.19284.
PubMed 26813210Baker TB, Piper ME, Smith SS, Bolt DM, Stein JH, Fiore MC. Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2021 Oct 19;326(15):1485-1493. doi: 10.1001/jama.2021.15333.
PubMed 34665204
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW Quitting Using Intensive Treatment Study
- ClinicalTrials.gov ID
- NCT03176784
- Acronym / sponsor ID
- QUITS / 2017-0404
- Conditions
- Tobacco Dependence
- Keywords
- Varenicline, Nicotine Patch, Quit Smoking, Tobacco, Cigarettes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,251 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.
Detailed description
Building on our recent NHLBI-funded publication in JAMA (see references below) that described the modest effectiveness of varenicline pharmacotherapy, this study will use a 2 X 2 factorial design to evaluate two different medication use strategies on their ability to markedly enhance varenicline effectiveness in a large cohort of current smokers. Smokers (N=1000) will be randomly assigned to one of two levels for each of two factors: 1) an Adjuvant factor (varenicline + placebo patch versus varenicline + nicotine patch), and 2) a Duration factor (12 versus 24 weeks of active medication). Thus, this factorial design yields a "standard" varenicline treatment (12 weeks of active varenicline and 12 weeks of placebo varenicline + 24 weeks of placebo patch), and 3 enhanced treatments: 1) 12 weeks of active varenicline and 12 weeks of placebo varenicline + 24 weeks of active patch, 2) 24-weeks of active varenicline + 24 weeks of placebo patch, and 3) 24 weeks of active varenicline + 24 weeks of active patch.
Both treatment modifications, longer duration therapy and use of a nicotine replacement therapy (NRT) adjuvant, have produced some quite promising effects. However, in both cases these modifications have been little researched, their effects are not consistently positive, and they have not been implemented in a potentially optimal manner. We will implement each modification in an innovative manner designed to enhance its effectiveness. In addition, all participants will be given counseling that supports adherent medication use and that is readily translatable to healthcare settings. The scientific rigor of this work will be enhanced by the use of placebo medication, a large sample, and a factorial design. The latter will allow us to test both the main and interaction effects of the experimental factors. We will also be able to compare each enhanced treatment with standard 12-week varenicline-only therapy to determine whether any of these medication use strategies significantly enhances treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Double Blinded Placebo Controlled Factorial
| Arm | Type | Receives |
|---|---|---|
| Varenicline + Patch Standard Duration | Experimental | Drug: Varenicline, Drug: Nicotine patch, Other: Placebo Patch, Other: Placebo PillStandard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Nicotine Patches: Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24 |
| Varenicline Only Standard Duration | Experimental | Drug: Varenicline, Other: Placebo Patch, Other: Placebo PillStandard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit |
| Varenicline + Patch Extended Duration | Experimental | Drug: Varenicline, Drug: Nicotine patchExtended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22 Extended Condition Nicotine Patches: 14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit. |
| Varenicline Only Extended Duration | Experimental | Drug: Varenicline, Other: Placebo PatchExtended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22 Extended Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must: plan to stay in the area for the next 12 months, ability to read and write in English, smoke on average ≥5 cigarettes per day over the last 6 months, be ≥18 years old, desire to quit smoking but not be engaged currently in cessation treatment, report no use of pipe tobacco, cigars, snuff, e-cigarettes or chew in the last 30 days, have reliable phone access, willing and able to use both nicotine patch and varenicline, access to transportation to come to our clinic and, if female, not be pregnant and be using an acceptable birth control method/ method to prevent pregnancy. Smoking will be biochemically confirmed via a carbon monoxide (CO) breath test at the orientation session visit. Potential participants must have a CO test result of ≥5ppm for eligibility to participate.
Key exclusion criteria (5 listed)
- Current treatment for schizophrenia or a psychotic disorder; suicidal ideation in the past 12 months; history of suicidal attempts within the last 10 years; on dialysis or being told you have severe kidney disease; hospitalization for a stroke, heart attack, congestive heart failure or uncontrolled diabetes mellitus within the past year; history of seizure within the last year; currently taking Wellbutrin, Zyban, or Buproprion (Contrave is a weight-loss drug that has Wellbutrin in it) for reasons other than to quit smoking or taking to help quit smoking and not willing to stop for duration of the study; currently using any form of nicotine replacement (e.g., nicotine patch, nicotine gum, nicotine lozenge) or using Chantix or varenicline and not willing to stop for duration of the study; had a reaction to the nicotine patch that prevented them from continuing to use it; or currently participating in another smoking cessation study.
- Even though we screen out participants who are pregnant, plan to become pregnant, nursing, or are unwilling to take steps to avoid pregnancy, there is a chance that a participant eligible at consent could become pregnant later. She would then be considered part of a vulnerable group. Given the longitudinal nature of the research, a participant who becomes pregnant after enrolling will be given the choice of whether to 1) continue in the study (for counseling and other assessments) and agree to immediately stop taking study meds for the remaining duration of the study and return any unused medications, OR 2) withdraw. No further medications will be given to this study participant while in the study.
- Incarcerated individuals will not be enrolled in this study. However, given the longitudinal nature of the research, participants could be incarcerated for periods during their participation. If study staff learn that a participant is incarcerated at a time point before or at their Week 8 phone call, the participant will be withdrawn from the study. If study staff learn that a participant is incarcerated subsequent to Week 8, the participant will not be withdrawn unless that incarceration will take them beyond the study period. In that case, staff will not contact the participant while incarcerated and will not provide any treatment (counseling or medication) nor conduct any assessments during the period of incarceration. Services and assessments will be re-initiated if the participant is released at a later study time point.
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: Chantix0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.) | Drug | Varenicline + Patch Extended Duration, Varenicline + Patch Standard Duration, Varenicline Only Extended Duration, Varenicline Only Standard Duration |
| Nicotine patchAlso: Nicoderm CQ14 mg and 7 mg nicotine patches used. See arms for specific durations. | Drug | Varenicline + Patch Extended Duration, Varenicline + Patch Standard Duration |
| Placebo PatchPlacebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations. | Other | Varenicline + Patch Standard Duration, Varenicline Only Extended Duration, Varenicline Only Standard Duration |
| Placebo PillPlacebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.) | Other | Varenicline + Patch Standard Duration, Varenicline Only Standard Duration |
Primary outcome
52-Week Point-Prevalence Abstinence
Time frame: Assessed 52 weeks after quit date
Biochemically-confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
3 secondary outcomes
23-Week Point-Prevalence Abstinence
Time frame: Assessed 23 weeks after quit date
52-Week Prolonged Abstinence
Time frame: Assessed 52 weeks after quit date
23-Week Prolonged Abstinence
Time frame: Assessed 23 weeks after quit date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26813210Baker TB, Piper ME, Stein JH, Smith SS, Bolt DM, Fraser DL, Fiore MC. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):371-9. doi: 10.1001/jama.2015.19284.
- Derived from this study: PubMed 34665204Baker TB, Piper ME, Smith SS, Bolt DM, Stein JH, Fiore MC. Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2021 Oct 19;326(15):1485-1493. doi: 10.1001/jama.2021.15333.
- UW Center for Tobacco Research and Intervention websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data set will be posted by UW-CTRI in accord with NHLBI policies
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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.
Timothy B Baker, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline and Nicotine patch in people with Tobacco Dependence, run by University of Wisconsin, Madison at 2 sites 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 1 inclusion and 5 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 28 May 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?
52-Week Point-Prevalence Abstinence (time frame: Assessed 52 weeks after quit date). 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 NCT03176784, 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 23 Jan 2023.