Overcoming Nicotine Dependence to Enable Quitting (ON-DEQ)

A Mechanistic Test of Treatment Strategies to Foster Practice Quitting

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Tobacco Use; Nicotine Dependence; Smoking Behaviors; Nicotine Withdrawal
• Intervention / Treatment: Drug: Nicotine Replacement Therapy (NRT) Sampling; Behavioral: Practice Quitting (PQ) Counseling; Behavioral: Motivational Interviewing (MI) Counseling

Detailed 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. Practice quitting represents a useful treatment exercise, as it offers a point of focus for behavior change coaching and goal-setting, with or without a planned quit date. 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. Specific aims are to:

Aim 1: Evaluate hypothesized mechanisms of action for PQ counseling and NRT sampling on incidence of quit attempts by 6 months among current smokers who are not planning to quit in the next 30 days (N=780). We will test the mediational effect of each variable on the relationship between PQ-focused treatment and incidence of quit attempts.

Aim 2: Test both the individual and combined roles of PQ counseling and NRT sampling on incidence of quit attempts by 6 months. We hypothesize that PQ counseling combined with NRT sampling will produce the highest rates of quit attempts through an additive relationship between these two treatment components.

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Maritza Esqueda-Medina; Phone Number: 312-563-3702; Email: on-deq@rush.edu
• Study Contact Backup: Name: Amanda Mathew; Phone Number: 312-563-1273; Email: on-deq@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Principal Investigator: Amanda R Mathew, PhD
      • Contact: Maritza Esqueda-Medina; Phone Number: 312-563-3702; Email: Maritza_Esqueda-Medina@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition #1; NRT Sampling = On Behavioral Counseling = Practice Quitting	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.
Experimental: Condition #2; NRT Sampling = Off Behavioral Counseling = Practice Quitting	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.
Experimental: Condition #3; NRT sampling = On Behavioral counseling = Motivational Interviewing	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: 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.
Experimental: Condition #4; NRT sampling = Off Behavioral counseling = Motivational Interviewing	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any incidence of a quit attempt	Intentional abstinence of ≥ 24 hours between the end of treatment and the 6-month follow-up assessment	At 6-month follow-up assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence status at 1-month follow-up	Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).	At 1-month follow-up assessment
Abstinence status at 3-month follow-up	Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).	At 3-month follow-up assessment
Abstinence status at 6-month follow-up	Self-report of no smoking (not even a puff) within the previous 7 days, confirmed by an expired carbon monoxide (CO) reading of ≤ 6 parts per million (ppm).	At 6-month follow-up assessment

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Medical University of South Carolina
• Investigators: Principal Investigator: Amanda Mathew, PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: nicotine dependence; smoking cessation; tobacco; nicotine replacement therapy; behavioral treatment
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20121702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes