Overcoming Nicotine Dependence to Enable Quitting
ON-DEQ
A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
1 other identifier
interventional
780
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedStudy Start
First participant enrolled
March 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
August 17, 2025
August 1, 2025
4.4 years
August 16, 2022
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Abstinence status at 1-month follow-up
At 1-month follow-up assessment
Abstinence status at 3-month follow-up
At 3-month follow-up assessment
Abstinence status at 6-month follow-up
At 6-month follow-up assessment
Study Arms (4)
Condition #1
EXPERIMENTALNRT Sampling = On Behavioral Counseling = Practice Quitting
Condition #2
EXPERIMENTALNRT Sampling = Off Behavioral Counseling = Practice Quitting
Condition #3
EXPERIMENTALNRT sampling = On Behavioral counseling = Motivational Interviewing
Condition #4
EXPERIMENTALNRT sampling = Off Behavioral counseling = Motivational Interviewing
Interventions
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 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 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.
Eligibility Criteria
You may qualify if:
- Eligible participants will be males and females who:
- are 18 years or older
- report current daily cigarette smoking (≥ 5 cigarettes per day)
- are not planning to quit in the next 30 days
- are not currently engaged in smoking cessation treatment
- 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
- are English speaking
- reside in the continental United States
- have access to a smartphone that can be used to complete study procedures
You may not qualify if:
- 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:
- are pregnant/breastfeeding
- had recent cardiovascular trauma such as myocardial infarction
- had a stroke within the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda Mathew, PhD
Rush University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2022
First Posted
August 24, 2022
Study Start
March 24, 2023
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share