A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
Primary Purpose
Tobacco Use, Smoking Cessation, Smoking Behaviors
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine Replacement Therapy (NRT) Sampling
Practice Quitting (PQ) Counseling
Motivational Interviewing (MI) Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use focused on measuring tobacco, smoking cessation, nicotine dependence, nicotine replacement therapy, behavioral treatment
Eligibility Criteria
Inclusion Criteria:
Eligible participants will be males and females who:
- are 18 years or older
- report current daily cigarette smoking (≥ 5 cigarettes per day)
- are not planning to quit in the next 30 days
- are motivated to quit or engage in a non-cessation goal (i.e., reduce smoking, learn more about treatment options, and/ or try out skills to change smoking) in the next 6 months
- are English speaking
- have access to a smartphone that can be used to complete study procedures
Exclusion Criteria:
Participants will be excluded for any FDA contraindications for NRT use if they:
- are pregnant/breastfeeding
- had recent cardiovascular trauma such as myocardial infarction
- had a stroke within the past 3 months
Sites / Locations
- Rush University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Condition #1
Condition #2
Condition #3
Condition #4
Arm Description
NRT Sampling = On Behavioral Counseling = Practice Quitting
NRT Sampling = Off Behavioral Counseling = Practice Quitting
NRT sampling = On Behavioral counseling = Motivational Interviewing
NRT sampling = Off Behavioral counseling = Motivational Interviewing
Outcomes
Primary Outcome Measures
Any incidence of a quit attempt
Intentional abstinence of ≥ 24 hours between the end of treatment and the 6-month follow-up assessment
Secondary Outcome Measures
Abstinence status at 1-month follow-up
Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).
Abstinence status at 3-month follow-up
Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).
Abstinence status at 6-month follow-up
Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).
Full Information
NCT ID
NCT05513872
First Posted
August 16, 2022
Last Updated
March 1, 2023
Sponsor
Rush University Medical Center
Collaborators
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05513872
Brief Title
A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
Official Title
A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 30, 2027 (Anticipated)
Study Completion Date
August 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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. Practice quitting represents a useful treatment exercise, as it offers a point of focus for behavior change coaching and goal-setting, with or without a planned quit date. 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. Specific aims are to:
Aim 1: Evaluate hypothesized mechanisms of action for PQ counseling and NRT sampling on incidence of quit attempts by 6 months among current smokers who are not planning to quit in the next 30 days (N=780). We will test the mediational effect of each variable on the relationship between PQ-focused treatment and incidence of quit attempts.
Aim 2: Test both the individual and combined roles of PQ counseling and NRT sampling on incidence of quit attempts by 6 months. We hypothesize that PQ counseling combined with NRT sampling will produce the highest rates of quit attempts through an additive relationship between these two treatment components.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Smoking Cessation, Smoking Behaviors, Nicotine Dependence, Nicotine Withdrawal
Keywords
tobacco, smoking cessation, nicotine dependence, nicotine replacement therapy, behavioral treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
780 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Condition #1
Arm Type
Experimental
Arm Description
NRT Sampling = On Behavioral Counseling = Practice Quitting
Arm Title
Condition #2
Arm Type
Experimental
Arm Description
NRT Sampling = Off Behavioral Counseling = Practice Quitting
Arm Title
Condition #3
Arm Type
Experimental
Arm Description
NRT sampling = On Behavioral counseling = Motivational Interviewing
Arm Title
Condition #4
Arm Type
Experimental
Arm Description
NRT sampling = Off Behavioral counseling = Motivational Interviewing
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy (NRT) Sampling
Intervention Description
Participants randomized to this condition will receive a 4-week nicotine replacement therapy (NRT) starter kit containing both nicotine lozenges and patches in their original packaging.
Intervention Type
Behavioral
Intervention Name(s)
Practice Quitting (PQ) Counseling
Intervention Description
Practice Quitting (PQ) counseling will consist of four weekly treatment sessions, with an initial 45-minute session followed by three 20-minute sessions. The goals of the counseling sessions are 1) to gradually expose patients to nicotine withdrawal symptoms through practice quitting, and 2) to reduce fear and avoidance of the physical sensations associated with nicotine withdrawal.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI) Counseling
Intervention Description
Motivational Interviewing (MI) counseling will consist of four weekly treatment sessions, with an initial 45-minute session followed by three 20-minute sessions. Counseling content will incorporate MI-consistent principles, such as open questions, simple and complex reflections, and affirmations to facilitate participant statements in favor of behavior change. Discussion will focus on the motivational topics outlined in the USPHS guidelines for smokers not ready to quit: 1) relevance of smoking cessation or reduction to the individual, 2) risks of continued heavy smoking, 3) rewards of quitting and reduction, and 4) roadblocks to success, on a 5) repeated basis.
Primary Outcome Measure Information:
Title
Any incidence of a quit attempt
Description
Intentional abstinence of ≥ 24 hours between the end of treatment and the 6-month follow-up assessment
Time Frame
At 6-month follow-up assessment
Secondary Outcome Measure Information:
Title
Abstinence status at 1-month follow-up
Description
Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).
Time Frame
At 1-month follow-up assessment
Title
Abstinence status at 3-month follow-up
Description
Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).
Time Frame
At 3-month follow-up assessment
Title
Abstinence status at 6-month follow-up
Description
Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).
Time Frame
At 6-month follow-up assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible participants will be males and females who:
are 18 years or older
report current daily cigarette smoking (≥ 5 cigarettes per day)
are not planning to quit in the next 30 days
are not currently engaged in smoking cessation treatment
are motivated to quit or engage in a non-cessation goal (i.e., reduce smoking, learn more about treatment options, and/ or try out skills to change smoking) in the next 6 months
are English speaking
reside in the continental United States
have access to a smartphone that can be used to complete study procedures
Exclusion Criteria:
Participants will be excluded for daily vaping/ electronic cigarettes use (i.e., use for ≥ 25 days within past 30 days) and any FDA contraindications for NRT use if they:
are pregnant/breastfeeding
had recent cardiovascular trauma such as myocardial infarction
had a stroke within the past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maritza Esqueda-Medina
Phone
312-563-3702
Email
Maritza_Esqueda-Medina@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Mathew
Phone
312-563-1273
Email
amanda_mathew@rush.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Mathew, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maritza Esqueda-Medina
Phone
312-563-3702
Email
Maritza_Esqueda-Medina@rush.edu
First Name & Middle Initial & Last Name & Degree
Amanda R Mathew, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
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