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A Comparative Effectiveness RCT of Optimized Cessation Treatments

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ClinicalTrials.gov Identifier: NCT02301403
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Penn State University
University of Illinois at Chicago
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation 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 Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Effectiveness RCT of Optimized Cessation Treatments
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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




Primary Outcome Measures :
  1. Number of Participants With Abstinence From Smoking [ Time Frame: 6 months post treatment ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301403


Locations
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United States, Wisconsin
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Penn State University
University of Illinois at Chicago
Investigators
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Principal Investigator: Megan Piper, PhD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Informed Consent Form  [PDF] December 9, 2014


Additional Information:
Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02301403     History of Changes
Other Study ID Numbers: 2014-1041 Cessation
First Posted: November 25, 2014    Key Record Dates
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019
Last Verified: April 2019

Keywords provided by University of Wisconsin, Madison:
smoking
cessation
tobacco

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action