A Comparative Effectiveness RCT of Optimized Cessation Treatments

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.

Conditions

• Smoking Cessation

Interventions

DRUG

Nicotine patch

8 weeks of nicotine patch

BEHAVIORAL

in-person counseling and quitline counseling

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

DRUG

Preparation Nicotine Mini-Lozenges

Nicotine lozenge prior to attempting to quit smoking

DRUG

Combination NRT (nicotine patch + nicotine mini-lozenges)

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

BEHAVIORAL

Intensive In-Person Cessation Counseling

three 20-min In-person Cessation Counseling sessions

BEHAVIORAL

Extended Maintenance Counseling Calls

8 Maintenance-phase smoking cessation counseling sessions

BEHAVIORAL

Automated Adherence Calls

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

Sponsors & Collaborators

• Penn State University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Megan Piper, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-12-31

Completion

2018-02-28

Countries

• United States

Study Locations