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RECRUITING
NCT05513872
PHASE1/PHASE2

Overcoming Nicotine Dependence to Enable Quitting

Sponsor: Rush University Medical Center

View on ClinicalTrials.gov

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.

Official title: A Mechanistic Test of Treatment Strategies to Foster Practice Quitting

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

780

Start Date

2023-03-24

Completion Date

2027-08-30

Last Updated

2025-08-17

Healthy Volunteers

No

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.

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States