Tobacco UsePhase 1/2ON-DEQNCT05513872
Overcoming Nicotine Dependence to Enable Quitting
A Phase 1/2 study testing Nicotine Replacement Therapy (NRT) Sampling, Practice Quitting (PQ) Counseling and Motivational Interviewing (MI) Counseling in people with Tobacco Use and Smoking Cessation, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use, Smoking Cessation, Smoking Behaviors
- What is being tested?
- Nicotine Replacement Therapy (NRT) Sampling, Practice Quitting (PQ) Counseling and Motivational Interviewing (MI) Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 30 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- are English speaking
- reside in the continental United States
- have access to a smartphone that can be used to complete study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Maritza Esqueda-Medina, 312-563-3702, Maritza_Esqueda-Medina@rush.edu
Amanda R Mathew, PhD
About this study
Official title: A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
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.
Read the 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.
- Conditions
- Tobacco Use, Smoking Cessation, Smoking Behaviors, Nicotine Dependence, Nicotine Withdrawal
- Being tested
- Nicotine Replacement Therapy (NRT) Sampling, Practice Quitting (PQ) Counseling, Motivational Interviewing (MI) Counseling
- Keywords
- tobacco, smoking cessation, nicotine dependence, nicotine replacement therapy, behavioral treatment
- Medical subject headings
- Tobacco Use, Smoking Cessation, Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT) SamplingDrug
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) CounselingBehavioural
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) CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition #1 | Experimental | NRT Sampling = On Behavioral Counseling = Practice Quitting Receives: Drug: Nicotine Replacement Therapy (NRT) Sampling; Behavioral: Practice Quitting (PQ) Counseling |
| Condition #2 | Experimental | NRT Sampling = Off Behavioral Counseling = Practice Quitting Receives: Behavioral: Practice Quitting (PQ) Counseling |
| Condition #3 | Experimental | NRT sampling = On Behavioral counseling = Motivational Interviewing Receives: Drug: Nicotine Replacement Therapy (NRT) Sampling; Behavioral: Motivational Interviewing (MI) Counseling |
| Condition #4 | Experimental | NRT sampling = Off Behavioral counseling = Motivational Interviewing Receives: Behavioral: Motivational Interviewing (MI) Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any incidence of a quit attempt
Intentional abstinence of ≥ 24 hours between the end of treatment and the 6-month follow-up assessment
Measured: At 6-month follow-up assessment
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: At 6-month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start24 Mar 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Amanda Mathew, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513872
- Sponsor's protocol ID
- 20121702
- Acronym
- ON-DEQ
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
- ClinicalTrials.gov ID
- NCT05513872
- Acronym / sponsor ID
- ON-DEQ / 20121702
- Conditions
- Tobacco Use, Smoking Cessation, Smoking Behaviors, Nicotine Dependence, Nicotine Withdrawal
- Keywords
- tobacco, smoking cessation, nicotine dependence, nicotine replacement therapy, behavioral treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Condition #1 | Experimental | Drug: Nicotine Replacement Therapy (NRT) Sampling, Behavioral: Practice Quitting (PQ) CounselingNRT Sampling = On Behavioral Counseling = Practice Quitting |
| Condition #2 | Experimental | Behavioral: Practice Quitting (PQ) CounselingNRT Sampling = Off Behavioral Counseling = Practice Quitting |
| Condition #3 | Experimental | Drug: Nicotine Replacement Therapy (NRT) Sampling, Behavioral: Motivational Interviewing (MI) CounselingNRT sampling = On Behavioral counseling = Motivational Interviewing |
| Condition #4 | Experimental | Behavioral: Motivational Interviewing (MI) CounselingNRT sampling = Off Behavioral counseling = Motivational Interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (NRT) SamplingParticipants 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. | Drug | Condition #1, Condition #3 |
| Practice Quitting (PQ) CounselingPractice 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. | Behavioural | Condition #1, Condition #2 |
| Motivational Interviewing (MI) CounselingMotivational 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. | Behavioural | Condition #3, Condition #4 |
Primary outcome
Any incidence of a quit attempt
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
3 secondary outcomes
Abstinence status at 1-month follow-up
Time frame: At 1-month follow-up assessment
Abstinence status at 3-month follow-up
Time frame: At 3-month follow-up assessment
Abstinence status at 6-month follow-up
Time frame: At 6-month follow-up assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Mathew, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nicotine Replacement Therapy (NRT) Sampling, Practice Quitting (PQ) Counseling and Motivational Interviewing (MI) Counseling in people with Tobacco Use and Smoking Cessation, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maritza Esqueda-Medina (312-563-3702, on-deq@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any incidence of a quit attempt (time frame: At 6-month follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.