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UW Quitting Using Intensive Treatment Study (QUITS) (QUITS)

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ClinicalTrials.gov Identifier: NCT03176784
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: Varenicline Drug: Nicotine patch Other: Placebo Patch Other: Placebo Pill Phase 4

Detailed Description:

Building on our recent NHLBI-funded publication in JAMA (1) 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.

(1) 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 WeeksA Randomized Clinical Trial. JAMA. 2016;315(4):371-379


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Double Blinded Placebo Controlled Factorial
Masking: Double (Participant, Care Provider)
Masking Description: Active and placebo medications are identical in appearance. Medication labeling and the dispensing protocol are designed to prevent participants and care providers from knowing if the medication is active or placebo.
Primary Purpose: Treatment
Official Title: UW Quitting Using Intensive Treatment Study
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Varenicline + Patch Standard Duration

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 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

Drug: Varenicline
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.)
Other Name: Chantix

Drug: Nicotine patch
14 mg and 7 mg nicotine patches used. See arms for specific durations.
Other Name: Nicoderm CQ

Other: Placebo Patch
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.

Other: Placebo Pill
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.)

Experimental: Varenicline Only Standard Duration

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

Drug: Varenicline
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.)
Other Name: Chantix

Other: Placebo Patch
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.

Other: Placebo Pill
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.)

Experimental: Varenicline + Patch Extended Duration

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.

Drug: Varenicline
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.)
Other Name: Chantix

Drug: Nicotine patch
14 mg and 7 mg nicotine patches used. See arms for specific durations.
Other Name: Nicoderm CQ

Experimental: Varenicline Only Extended Duration

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

Drug: Varenicline
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.)
Other Name: Chantix

Other: Placebo Patch
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.




Primary Outcome Measures :
  1. 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 <=5 ppm.


Secondary Outcome Measures :
  1. 23-Week Point-Prevalence Abstinence [ Time Frame: Assessed 23 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 <=5 ppm.

  2. 52-Week Prolonged Abstinence [ Time Frame: Assessed 52 weeks after quit date ]
    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 <=5 ppm.

  3. 23-Week Prolonged Abstinence [ Time Frame: Assessed 23 weeks after quit date ]
    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 <=5 ppm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

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.

Exclusion criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176784


Contacts
Contact: Stevens S Smith, PhD 6082627563 sss@ctri.wisc.edu
Contact: Madeine K Oguss, BA 6082655552 mkoguss@ctri.wisc.edu

Locations
United States, Wisconsin
UW Center For Tobacco Research and Intervention Recruiting
Madison, Wisconsin, United States, 53711
Contact: Madeline Oguss, BA    608-265-5552    mkoguss@ctri.wisc.edu   
UW Center for Tobacco Research and Intervention Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Madeline Oguss, BA    608-265-5552    mkoguss@ctri.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Timothy B Baker, PhD University of Wisconsin, Madison

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03176784     History of Changes
Other Study ID Numbers: 2017-0404
R01HL109031 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data set will be posted by UW-CTRI in accord with NHLBI policies
Time Frame: 12 months after publication of the primary outcome paper.
Access Criteria: Prior written data request to the PI.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Wisconsin, Madison:
Varenicline
Nicotine Patch
Quit Smoking
Tobacco
Cigarettes

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action