CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 623 enrolled
Drug / intervention
Nicotine patch +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02301403
NCT02301403Phase 4Completed
CompareCT.gov

A Comparative Effectiveness RCT of Optimized Cessation Treatments

University of Wisconsin, Madison·interventional·Posted Nov 25, 2014·Updated May 13, 2020

In Brief

A Phase 4 clinical trial evaluating Nicotine patch, in-person counseling and quitline counseling, and 5 other interventions for Smoking Cessation. Completed, enrolled 623 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
CollaboratorsPenn State University, University of Illinois at Chicago

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 25, 2014
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2017
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.6 years ago

Interventions

Nicotine patchdrug

8 weeks of nicotine patch

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

Preparation Nicotine Mini-Lozengesdrug

Nicotine lozenge prior to attempting to quit smoking

Combination NRT (nicotine patch + nicotine mini-lozenges)drug

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

Intensive In-Person Cessation Counselingbehavioral

three 20-min In-person Cessation Counseling sessions

Extended Maintenance Counseling Callsbehavioral

8 Maintenance-phase smoking cessation counseling sessions

Automated Adherence Callsbehavioral

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