Overcoming Nicotine Dependence to Enable Quitting
Key facts
- Who runs it
- Rush University Medical Center
- Where
- Chicago, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 780 people, planned
- Started
- 24 Mar 2023
- Expected to end
- 30 Aug 2027
- Type of study
- Interventional, 4 groups
- Treatments tested
- Nicotine Replacement Therapy (NRT) Sampling
- Practice Quitting (PQ) Counseling
- Motivational Interviewing (MI) Counseling
- Record updated
- 9 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- had recent cardiovascular trauma such as myocardial infarction
- had a stroke within the past 3 months
- 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
Where in United States
- Rush University Medical CenterChicago, United StatesContact: Maritza Esqueda-MedinaTaking people
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- Condition #1Treatment being tested
NRT Sampling = On Behavioral Counseling = Practice Quitting
Treatment: Nicotine Replacement Therapy (NRT) Sampling and Practice Quitting (PQ) Counseling
- Condition #2Treatment being tested
NRT Sampling = Off Behavioral Counseling = Practice Quitting
Treatment: Practice Quitting (PQ) Counseling
- Condition #3Treatment being tested
NRT sampling = On Behavioral counseling = Motivational Interviewing
Treatment: Nicotine Replacement Therapy (NRT) Sampling and Motivational Interviewing (MI) Counseling
- Condition #4Treatment being tested
NRT sampling = Off Behavioral counseling = Motivational Interviewing
Treatment: Motivational Interviewing (MI) Counseling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
- Record updated
- 9 September 2026