UW Quitting Using Intensive Treatment Study (QUITS)

NCT03176784 | Completed Phase 4 Results DMC FDA Drug

• 5 other identifiers: 2017-0404R01HL109031A534253SMPH/MEDICINE/GEN INT MDProtocol Version 6/11/2020
• Study Type: interventional
• Target: 1,251
• Locations: 1 country
• Sites: 2

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.

Conditions

Tobacco Dependence

Keywords

Varenicline; Nicotine Patch; Quit Smoking; Tobacco; Cigarettes

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed 52 weeks after quit date

Secondary Outcomes (3)

• 23-Week Point-Prevalence Abstinence

  Assessed 23 weeks after quit date

• 52-Week Prolonged Abstinence

  Assessed 52 weeks after quit date

• 23-Week Prolonged Abstinence

  Assessed 23 weeks after quit date

Study Arms (4)

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

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

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.

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

Drug: Varenicline; Other: Placebo Patch

Interventions

Varenicline DRUG

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.)

Also known as: Chantix

Varenicline + Patch Extended Duration; Varenicline + Patch Standard Duration; Varenicline Only Extended Duration; Varenicline Only Standard Duration

Nicotine patch DRUG

14 mg and 7 mg nicotine patches used. See arms for specific durations.

Also known as: Nicoderm CQ

Varenicline + Patch Extended Duration; Varenicline + Patch Standard Duration

Placebo Patch OTHER

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.

Varenicline + Patch Standard Duration; Varenicline Only Extended Duration; Varenicline Only Standard Duration

Placebo Pill OTHER

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.)

Varenicline + Patch Standard Duration; Varenicline Only Standard Duration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Washington University School of Medicine: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

UW Center For Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

UW Center for Tobacco Research and Intervention

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (2)

• 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.

  PMID: 26813210 BACKGROUND

• Baker 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.

  PMID: 34665204 DERIVED

Related Links

• UW Center for Tobacco Research and Intervention website

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics; Solanaceous Alkaloids; Alkaloids; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Stevens S. Smith, Ph.D.
• Organization: University of Wisconsin School of Medicine and Public Health

sss@ctri.wisc.edu

608-262-7563

Study Officials

• Timothy B Baker, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double Blinded Placebo Controlled Factorial

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 6, 2017
• Study Start: November 11, 2017
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: January 23, 2023
• Results First Posted: May 28, 2021

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 12 months after publication of the primary outcome paper.
• Access Criteria: Prior written data request to the PI.

Locations

US (2)