A Phase 1/2 interventional study of Nicotine Replacement Therapy (NRT) Sampling and Practice Quitting (PQ) Counseling in Tobacco Use, Smoking Cessation and Smoking Behaviors, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Rush University Medical Center · Phase 1/2, Interventional, and Treatment
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.
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.
420 studies on the registry are indexed under Tobacco Use; 82 are open to participants now.
This study's planned enrollment of 780 is above the median of 124 across 351 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
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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 for NRT use if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NRT Sampling = On Behavioral Counseling = Practice Quitting
Drug: Nicotine Replacement Therapy (NRT) Sampling · Behavioral: Practice Quitting (PQ) Counseling
NRT Sampling = Off Behavioral Counseling = Practice Quitting
Behavioral: Practice Quitting (PQ) Counseling
NRT sampling = On Behavioral counseling = Motivational Interviewing
Drug: Nicotine Replacement Therapy (NRT) Sampling · Behavioral: Motivational Interviewing (MI) Counseling
NRT sampling = Off Behavioral counseling = Motivational Interviewing
Behavioral: Motivational Interviewing (MI) Counseling
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.
Any incidence of a quit attempt
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
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).
Time frame: At 1-month follow-up assessment
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).
Time frame: At 3-month follow-up assessment
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).
Time frame: At 6-month follow-up assessment
Plan to share: No
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