Rush University Medical Center
Chicago, Illinois, 60612, United States
Location status: Recruiting
Location contact
Amanda R Mathew, PhD
PRINCIPAL_INVESTIGATOR
Maritza Esqueda-Medina
CONTACT
NCT Number: NCT05513872
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Chicago, Illinois, 60612, United States
Location status: Recruiting
Amanda R Mathew, PhD
PRINCIPAL_INVESTIGATOR
Maritza Esqueda-Medina
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible participants will be males and females who:
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:
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.
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.
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.
Time frame: At 6-month follow-up assessment
Intentional abstinence of ≥ 24 hours between the end of treatment and the 6-month follow-up assessment
Time frame: At 1-month follow-up assessment
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
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
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).
Contact information is provided by the study sponsor or research team.
Amanda Mathew
CONTACT
Maritza Esqueda-Medina
CONTACT
Rush University Medical Center
Other
A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
Acronym: ON-DEQ
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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