A Comparative Effectiveness RCT of Optimized Cessation Treatments

University of Wisconsin (UW)

Status and phase

Completed

Phase 4

Conditions

Smoking Cessation

Treatments

Drug: Preparation Nicotine Mini-Lozenges

Behavioral: Intensive In-Person Cessation Counseling

Drug: Nicotine patch

Drug: Combination NRT (nicotine patch + nicotine mini-lozenges)

Behavioral: in-person counseling and quitline counseling

Behavioral: Automated Adherence Calls

Behavioral: Extended Maintenance Counseling Calls

Study type

Interventional

Funder types

Other

Identifiers

NCT02301403

A534252 (Other Identifier)

SMPH\MEDICINE\TOBACCO RE (Other Identifier)

2014-1041 Cessation

Details and patient eligibility

About

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.

Full description

The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package

Enrollment

623 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

623 participants in 2 patient groups

Modern Usual Care

Active Comparator group

Description:

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).

Treatment:

Drug: Nicotine patch

Behavioral: in-person counseling and quitline counseling

Abstinence-Optimized Cessation Treatment

Experimental group