Recruiting
Phase 1
Phase 2

Nicotine Dependence

Sponsor:

Rush University Medical Center

Code:

NCT05513872

Conditions

Tobacco Use

Smoking Cessation

Smoking Behaviors

Nicotine Dependence

Nicotine Withdrawal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nicotine Replacement Therapy (NRT) Sampling

Practice Quitting (PQ) Counseling

Motivational Interviewing (MI) Counseling

Study Details

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.

Conditions

Tobacco Use

Smoking Cessation

Smoking Behaviors

Nicotine Dependence

Nicotine Withdrawal

Study ID

NCT05513872

Start date

Mar 24, 2023

Status verified date

Aug, 2025

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

780 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Condition #1

NRT Sampling = On Behavioral Counseling = Practice Quitting

experimental: Condition #2

NRT Sampling = Off Behavioral Counseling = Practice Quitting

experimental: Condition #3

NRT sampling = On Behavioral counseling = Motivational Interviewing

experimental: Condition #4

NRT sampling = Off Behavioral counseling = Motivational Interviewing

Interventions

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.

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.

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 measure

  • Any incidence of a quit attempt [ Time Frame: At 6-month follow-up assessment ]

Central Contacts and Locations

Central contacts

Maritza Esqueda-Medina

312-563-3702on-deq@rush.edu

Amanda Mathew

312-563-1273on-deq@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Maritza Esqueda-Medina

312-563-3702Maritza_Esqueda-Medina@rush.edu

Principal Investigator:

Amanda R Mathew, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 17, 2025

Last verified

Aug, 2025

Keywords

  • tobacco
  • smoking cessation
  • nicotine dependence
  • nicotine replacement therapy
  • behavioral treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-08-17.