Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID05513872

A Mechanistic Test of Treatment Strategies to Foster Practice Quitting Overcoming Nicotine Dependence to Enable Quitting

Led by Rush University Medical Center · Updated on 2025-08-17

780

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Rush University Medical Center

Lead Sponsor

M

Medical University of South Carolina

Collaborating Sponsor

AI-Summary

What this Trial Is About

Tobacco use disorder is a chronic condition that often requires ongoing care, but most traditional quitting programs focus only on smokers ready to set a quit date. This trial explores how to better support smokers who are not yet ready to quit by testing two strategies: counseling focused on practice quitting (trying to stop smoking for short periods without pressure to quit permanently) and motivational interviewing counseling, combined with or without nicotine replacement therapy (NRT) sampling. Participants will be assigned to one of four groups combining practice quitting or motivational interviewing counseling with or without a four-week supply of nicotine lozenges and patches. Counseling involves four weekly sessions, including an initial 45-minute session followed by three 20-minute sessions. Practice quitting counseling aims to help smokers experience withdrawal symptoms safely, while motivational interviewing focuses on motivation and readiness to change smoking behavior. During the study, participants will be monitored over six months to see if they attempt to quit smoking. Follow-up assessments will track quit attempts and abstinence status at one, three, and six months. The study involves smartphone-based procedures and will measure outcomes such as incidence of quit attempts, helping researchers understand which treatments encourage smokers to try quitting even if they are initially unwilling to set a quit date.

CONDITIONS

Brief Title

Overcoming Nicotine Dependence to Enable Quitting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Current daily cigarette smoking of 5 or more cigarettes per day
  • Not planning to quit smoking within the next 30 days
  • Not currently engaged in any smoking cessation treatment
  • Motivated to quit or reduce smoking or try new skills within the next 6 months
  • Able to speak English
  • Resides in the continental United States
  • Has access to a smartphone for study procedures
Not Eligible

You will not qualify if you...

  • Daily use of vaping or electronic cigarettes for 25 or more days in the past 30 days
  • Pregnant or breastfeeding
  • Recent cardiovascular trauma such as myocardial infarction
  • Stroke within the past 3 months

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive weekly counseling sessions over 4 weeks and may receive a 4-week supply of nicotine lozenges and patches depending on their assigned group.

4 weekly visits (in-person or remote) for counseling sessions

Follow-up

Duration - 6 months

Participants are assessed for quit attempts and abstinence status at 1, 3, and 6 months after treatment.

3 follow-up visits at 1, 3, and 6 months

Trial Site Locations

Total: 1 location

1

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

M

Maritza Esqueda-Medina

A

Amanda Mathew

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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