NCT05513872 · Rush University Medical Center
Overcoming Nicotine Dependence to Enable Quitting
(ON-DEQ)
What this study is about
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.
View original scientific 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. 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.
Interventions
DRUG
Nicotine Replacement Therapy (NRT) Sampling
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.
BEHAVIORAL
Practice Quitting (PQ) Counseling
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.
BEHAVIORAL
Motivational Interviewing (MI) Counseling
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 measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Collaborators
Medical University of South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2025 · Source of record for eligibility and locations