NCT05513872 Overcoming Nicotine Dependence to Enable Quitting
| NCT ID | NCT05513872 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rush University Medical Center |
| Condition | Tobacco Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 780 participants |
| Start Date | 2023-03-24 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 780 participants in total. It began in 2023-03-24 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: Eligible participants will be males and females who: 1. are 18 years or older 2. report current daily cigarette smoking (≥ 5 cigarettes per day) 3. are not planning to quit in the next 30 days 4. are not currently engaged in smoking cessation treatment 5. 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 6. are English speaking 7. reside in the continental United States 8. 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: 1. are pregnant/breastfeeding 2. had recent cardiovascular trauma such as myocardial infarction 3. had a stroke within the past 3 months
Contact & Investigator
Amanda Mathew, PhD
PRINCIPAL INVESTIGATOR
Rush University Medical Center
Frequently Asked Questions
Who can join the NCT05513872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05513872 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05513872 currently recruiting?
Yes, NCT05513872 is actively recruiting participants. Contact the research team at on-deq@rush.edu for enrollment information.
Where is the NCT05513872 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05513872 clinical trial?
NCT05513872 is sponsored by Rush University Medical Center. The principal investigator is Amanda Mathew, PhD at Rush University Medical Center. The trial plans to enroll 780 participants.