Condition #2 for Smoking Behaviors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rush University Medical Center, Chicago, IL
Smoking Behaviors+5 More
Motivational Interviewing (MI) Counseling - Behavioral
Eligibility
18+
All Sexes
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Study Summary

Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, traditional smoking cessation treatment programs allocate nearly all their resources only to those smokers who are willing to set a quit date. This is problematic because few smokers are ready to set a quit date at any given time, and a smoker's stated intention to quit can change rapidly. One novel potential treatment strategy is to foster practice quitting (PQ), defined as attempting to not smoke for a few hours or days, without pressure or expectation to permanently quit. Although a growing body of evidence supports the role of practice quitting in fostering permanent quit attempts and cessation, there is a significant knowledge gap regarding which treatment strategies should be used to engage smokers in practice quitting. The proposed study will test the role of PQ counseling vs. Motivational Interviewing (MI) counseling, and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none.

Eligible Conditions

  • Withdrawal Nicotine
  • Smoking, Cessation
  • Smoking Behaviors
  • Tobacco Use
  • Nicotine Dependence

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At 1-month follow-up assessment

At 1-month follow-up assessment
Abstinence status at 1-month follow-up
At 3-month follow-up assessment
Abstinence status at 3-month follow-up
At 6-month follow-up assessment
Abstinence status at 6-month follow-up
Any incidence of a quit attempt

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Condition #2
1 of 4
Condition #1
1 of 4
Condition #3
1 of 4
Condition #4
1 of 4
Experimental Treatment

780 Total Participants · 4 Treatment Groups

Primary Treatment: Condition #2 · No Placebo Group · Phase 1 & 2

Condition #2
Behavioral
Experimental Group · 1 Intervention: Practice Quitting (PQ) Counseling · Intervention Types: Behavioral
Condition #1Experimental Group · 2 Interventions: Nicotine Replacement Therapy (NRT) Sampling, Practice Quitting (PQ) Counseling · Intervention Types: Drug, Behavioral
Condition #3Experimental Group · 2 Interventions: Motivational Interviewing (MI) Counseling, Nicotine Replacement Therapy (NRT) Sampling · Intervention Types: Behavioral, Drug
Condition #4
Behavioral
Experimental Group · 1 Intervention: Motivational Interviewing (MI) Counseling · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Replacement Therapy (NRT) Sampling
2014
N/A
~1280

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1-month follow-up assessment
Closest Location: Rush University Medical Center · Chicago, IL
Photo of rush university medical center  1Photo of rush university medical center  2Photo of rush university medical center  3
2011First Recorded Clinical Trial
1 TrialsResearching Smoking Behaviors
790 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years old.
You are currently smoking.
You are not planning to quit smoking in the next 30 days.
You have access to a smartphone that can be used to complete study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.