A Comparative Effectiveness RCT of Optimized Cessation Treatments

Smoking Cessation Clinical Trial

Official title:

A Comparative Effectiveness RCT of Optimized Cessation Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301403
• Other study ID #: 2014-1041 Cessation
• Secondary ID: A534252SMPH\MEDI
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: February 2018

Study information

• Verified date: May 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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
• 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
• Extended Maintenance Counseling Calls
8 Maintenance-phase smoking cessation counseling sessions
• Automated Adherence Calls
11 brief, automated calls reminding them to use their medications properly

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Penn State University, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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