NCT02301403

Brief Summary

This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
623

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 25, 2019

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

November 21, 2014

Results QC Date

March 8, 2019

Last Update Submit

May 11, 2020

Conditions

Smoking Cessation

Keywords

smokingcessationtobacco

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Abstinence From Smoking

    The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \< 6 parts per million).

    6 months post treatment

Study Arms (2)

Modern Usual Care

ACTIVE COMPARATOR

Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).

Drug: Nicotine patchBehavioral: in-person counseling and quitline counseling

Abstinence-Optimized Cessation Treatment

EXPERIMENTAL

There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.

Drug: Preparation Nicotine Mini-LozengesDrug: Combination NRT (nicotine patch + nicotine mini-lozenges)Behavioral: Intensive In-Person Cessation CounselingBehavioral: Extended Maintenance Counseling CallsBehavioral: Automated Adherence Calls

Interventions

Nicotine patchDRUG

8 weeks of nicotine patch

Modern Usual Care
in-person counseling and quitline counselingBEHAVIORAL

a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website

Modern Usual Care
Preparation Nicotine Mini-LozengesDRUG

Nicotine lozenge prior to attempting to quit smoking

Abstinence-Optimized Cessation Treatment
Combination NRT (nicotine patch + nicotine mini-lozenges)DRUG

26 weeks of combination NRT as part of a quit smoking attempt

Abstinence-Optimized Cessation Treatment
Intensive In-Person Cessation CounselingBEHAVIORAL

three 20-min In-person Cessation Counseling sessions

Abstinence-Optimized Cessation Treatment
Extended Maintenance Counseling CallsBEHAVIORAL

8 Maintenance-phase smoking cessation counseling sessions

Abstinence-Optimized Cessation Treatment
Automated Adherence CallsBEHAVIORAL

11 brief, automated calls reminding them to use their medications properly

Abstinence-Optimized Cessation Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>=18 years
  • smoking \>4 cigarettes/day for the previous 6 months
  • able to read, write, and speak English
  • have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts
  • and if currently using NRT, agreeing to use only study medication for the duration of the study
  • we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses)
  • not currently attempting to quit smoking
  • not intending to quit smoking (defined as no plans to quit in the next month)
  • and planning to remain in the intervention catchment area for at least 12 months.

You may not qualify if:

  • currently taking bupropion or varenicline
  • medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days
  • diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years
  • and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madison, Wisconsin, 53711, United States

Location

Related Publications (2)

  • Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.

    PMID: 30212849RESULT

  • Theodoulou 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.

    PMID: 39868569DERIVED

Related Links

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Stevens S. Smith, Ph.D.
Organization
Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
sss@ctri.wisc.edu
6082627563

Study Officials

  • Megan Piper, 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

May 13, 2020

Results First Posted

April 25, 2019

Record last verified: 2020-05

Locations

US(1)