A Comparative Effectiveness RCT of Optimized Cessation Treatments

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 Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine patch; Behavioral: in-person counseling and quitline counseling; Drug: Preparation Nicotine Mini-Lozenges; Drug: Combination NRT (nicotine patch + nicotine mini-lozenges); Behavioral: Intensive In-Person Cessation Counseling; Behavioral: Extended Maintenance Counseling Calls; Behavioral: Automated Adherence Calls

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 623
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Modern Usual Care; 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 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
Experimental: Abstinence-Optimized Cessation Treatment; 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-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: University of Illinois at Chicago; Penn State University
• Investigators: Principal Investigator: Megan Piper, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Helpful Links

• Description: University of Wisconsin Center for Tobacco Research and Intervention

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: smoking; tobacco; cessation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2014-1041 Cessation; A534252 (Other Identifier: UW Madison); SMPH\MEDICINE\TOBACCO RE (Other Identifier: UW Madison)