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A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers (NHLBI-RO1)

Primary Purpose

Smoking Cessation, Smoking, Nicotine Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Nicotine lozenge
Nicotine Patch
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking Cessation, Smoking, Nicotine

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

We are only recruiting by invitation only (to members of our past cohort). We will open up enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012.

Inclusion Criteria:

a. To be eligible for the Comparative effectiveness trial, participants must:

  • smoke 5 or more cigarettes per day,
  • desire to quit smoking but not be currently engaged in cessation treatment,
  • be medically eligible to use either combination NRT or varenicline,
  • have reliable phone access,
  • if female, must not be pregnant and must be willing to use an acceptable birth control method.

Exclusion Criteria:

  1. There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments.
  2. All smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons:

    • end-stage renal disease with hemodialysis;
    • prior suicide attempts within the last 5 years or current suicidal ideation;
    • diagnosis of and/or treatment for schizophrenia;
    • other psychotic disorders or bipolar disorder within the last 10 years;
    • current PHQ-9 score indicative of moderately severe depression;
    • severe untreated hypertension >200/100 mmHg;
    • currently taking Wellbutrin, Zyban or bupropion;
    • hospitalized for a stroke, heart attack, congestive heart failure or diabetes within the last year;
    • used pipe tobacco, cigars, snuff or chew more than twice in the past week.

It should be noted that if any incidental findings appear in any of the cardiology tests (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental Information section of application), the study cardiologist (Dr. Stein or his designee) will be assign the participant to the non-randomized treatment arm and they will be given the nicotine patch and the same counseling intervention as CET participants. They will not be included in the CET analyses. This will be done to properly address the cardiovascular risk warning from the FDA regarding varenicline (Chantix).

Sites / Locations

  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Effectiveness of Nicotine patch only

Effectiveness of Combination NRT

Effectiveness of Varenicline [Chantix]

Arm Description

Outcomes

Primary Outcome Measures

Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of <10 ppm..

Secondary Outcome Measures

Number of Days to Relapse
The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.
Number of Participants With Initial Cessation in the First 7 Days Post-quit
Defined as at least 1 day of abstinence during the first 7 days after the target quit day.
The Effects of Quitting Smoking vs. Continued Smoking on Change in Carotid Intima-media Thickness (CIMT).
Change in carotid intima-media thickness (CIMT) from Baseline to Year 3 as a function of smoking status (abstinent versus smoking) at Year 3. Change is calculated as Baseline CIMT score minus Year 3 CIMT score. CIMT score is thickness of the carotid intima-media in millimeters (mm). Lower CIMT values indicate a better outcome.

Full Information

First Posted
November 9, 2011
Last Updated
August 31, 2020
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01553084
Brief Title
A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers
Acronym
NHLBI-RO1
Official Title
A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall purpose of this research is two-fold. First, the two smoking cessation medication treatments with the strongest evidence of effectiveness have never been directly compared. This research will determine how these two treatments compare in effectiveness in a head-to-head trial, and which types of smokers benefit most from each. Second, much of the data on smoking and health come from studies from many years ago. Today's smokers differ from earlier smokers in many ways that could influence the impact of smoking on health (e.g., weight, sex, diet, socio-economic status); the proposed work will determine how smoking cessation affects cardiovascular and pulmonary health in today's smokers.
Detailed Description
The proposed study will recruit and treat a large sample of contemporary smokers and former smokers at an age of increasing health risk, to achieve the following over-arching aims that are important to the NHLBI mission: Specific Aim 1: Produce important new data on how to treat smoking optimally by conducting an open label comparative effectiveness trial (CET) that for the first time directly contrasts the two smoking cessation pharmacotherapies with the strongest extant evidence of efficacy: combination NRT and varenicline. Specific Aim 2: Determine the impact of smoking cessation on biomarkers and health risk factors, especially those relevant to CVD, in today's smokers, which will elucidate the mechanisms via which cessation benefits health. Specific Aim 3: Identify which individuals are at greatest risk for exacerbation of biomarkers or risk factor status due to continued smoking, and who will benefit most from cessation. This will help identify individuals who are most in need of cessation intervention. While all smokers need to quit, this evidence could ultimately be used to help focus treatment and motivate smokers and clinicians to intervene more intensively with patients at greatest risk. Two secondary aims are to use the results of Primary Aim 1 to develop a treatment assignment algorithm for the optimal treatment of today's smokers and to use the results from Primary Aim 2 to determine the relation of health biomarkers to clinically meaningful disease outcomes such as CVD events. We will re-recruit as many smoking and non smoking participants from our past longitudinal cohort study("Wisconsin Smokers' Health study"; NCT01122238) in 2004. We will then recruit additional smokers to participate in the comparative effectiveness trial and join the longitudinal cohort.. All participants who enroll will complete questionnaires about their demographics, smoking history, withdrawal symptoms, affect, alcohol use, stressors, medication usage and diet. They will also complete a structured clinical interview to assess mental health. They will provide blood samples for testing of various markers of cardiovascular disease and risk as well as for genetics testing. They will all have carotid ultrasounds, pulmonary function tests, arterial tonometry assessments, and 12-lead ECGs. Participants in Madison will also have a treadmill stress test. Participants will wear a pedometer for 1 week and record the daily number of steps. Participants will provide permission for staff to review their medical charts to assess smoking-relevant diagnoses and treatment. These assessments will occur at baseline and again 3 years later. A smaller subset of these assessments will also be conducted 1 year after enrollment. Participants will also complete brief phone assessments at 6-month intervals up to the 3-year visit. Interested and eligible smoking participants from the original cohort study and all newly recruited participants will enroll in a new smoking cessation intervention study. Participants in the cessation treatment study will be randomly assigned to receive the nicotine patch, nicotine patch + nicotine lozenge or varenicline. If the participant from the original cohort study is not eligible to use all study medications but is otherwise eligible for cessation treatment, s/he will be assigned to a non-randomized treatment arm and will receive nicotine patch (if appropriate). All cessation participants will receive 6 individual counseling sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Smoking, Nicotine Dependence
Keywords
Smoking Cessation, Smoking, Nicotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1086 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effectiveness of Nicotine patch only
Arm Type
Experimental
Arm Title
Effectiveness of Combination NRT
Arm Type
Experimental
Arm Title
Effectiveness of Varenicline [Chantix]
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Varenicline
Intervention Description
Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Intervention Type
Drug
Intervention Name(s)
Nicotine lozenge
Intervention Description
Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Intervention Description
Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
Primary Outcome Measure Information:
Title
Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks
Description
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of <10 ppm..
Time Frame
Assessed 26 weeks after the target quit day.
Secondary Outcome Measure Information:
Title
Number of Days to Relapse
Description
The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.
Time Frame
Assessed from the target quit day through 26 weeks.
Title
Number of Participants With Initial Cessation in the First 7 Days Post-quit
Description
Defined as at least 1 day of abstinence during the first 7 days after the target quit day.
Time Frame
Assessed for the first seven days after the target quit date.
Title
The Effects of Quitting Smoking vs. Continued Smoking on Change in Carotid Intima-media Thickness (CIMT).
Description
Change in carotid intima-media thickness (CIMT) from Baseline to Year 3 as a function of smoking status (abstinent versus smoking) at Year 3. Change is calculated as Baseline CIMT score minus Year 3 CIMT score. CIMT score is thickness of the carotid intima-media in millimeters (mm). Lower CIMT values indicate a better outcome.
Time Frame
Assessed at Baseline and Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
We are only recruiting by invitation only (to members of our past cohort). We will open up enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012. Inclusion Criteria: a. To be eligible for the Comparative effectiveness trial, participants must: smoke 5 or more cigarettes per day, desire to quit smoking but not be currently engaged in cessation treatment, be medically eligible to use either combination NRT or varenicline, have reliable phone access, if female, must not be pregnant and must be willing to use an acceptable birth control method. Exclusion Criteria: There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments. All smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons: end-stage renal disease with hemodialysis; prior suicide attempts within the last 5 years or current suicidal ideation; diagnosis of and/or treatment for schizophrenia; other psychotic disorders or bipolar disorder within the last 10 years; current PHQ-9 score indicative of moderately severe depression; severe untreated hypertension >200/100 mmHg; currently taking Wellbutrin, Zyban or bupropion; hospitalized for a stroke, heart attack, congestive heart failure or diabetes within the last year; used pipe tobacco, cigars, snuff or chew more than twice in the past week. It should be noted that if any incidental findings appear in any of the cardiology tests (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental Information section of application), the study cardiologist (Dr. Stein or his designee) will be assign the participant to the non-randomized treatment arm and they will be given the nicotine patch and the same counseling intervention as CET participants. They will not be included in the CET analyses. This will be done to properly address the cardiovascular risk warning from the FDA regarding varenicline (Chantix).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Fiore, MD, MPH
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James H Stein, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26813210
Citation
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.
Results Reference
result
PubMed Identifier
35474254
Citation
Karim R, Xu W, Kono N, Sriprasert I, Li Y, Yan M, Stanczyk FZ, Shoupe D, Mack WJ, Hodis HN. Effect of menopausal hormone therapy on arterial wall echomorphology: Results from the Early versus Late Intervention Trial with Estradiol (ELITE). Maturitas. 2022 Aug;162:15-22. doi: 10.1016/j.maturitas.2022.02.007. Epub 2022 Mar 17.
Results Reference
derived
PubMed Identifier
32800078
Citation
Kaye JT, Johnson AL, Baker TB, Piper ME, Cook JW. Searching for Personalized Medicine for Binge Drinking Smokers: Smoking Cessation Using Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy. J Stud Alcohol Drugs. 2020 Jul;81(4):426-435. doi: 10.15288/jsad.2020.81.426.
Results Reference
derived
PubMed Identifier
31422759
Citation
Mitchell C, Piper ME, Smith SS, Korcarz CE, Fiore MC, Baker TB, Stein JH. Changes in carotid artery structure with smoking cessation. Vasc Med. 2019 Dec;24(6):493-500. doi: 10.1177/1358863X19867762. Epub 2019 Aug 17.
Results Reference
derived
PubMed Identifier
31056710
Citation
Schlam TR, Baker TB, Smith SS, Cook JW, Piper ME. Anxiety Sensitivity and Distress Tolerance in Smokers: Relations With Tobacco Dependence, Withdrawal, and Quitting Successdagger. Nicotine Tob Res. 2020 Jan 27;22(1):58-65. doi: 10.1093/ntr/ntz070.
Results Reference
derived
Links:
URL
http://www.ctri.wisc.edu/
Description
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

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A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

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