Overcoming Nicotine Dependence to Enable Quitting

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT05513872
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Nicotine Dependence
  • Nicotine Withdrawal
  • Smoking Behaviors
  • Smoking Cessation
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicotine Replacement Therapy (NRT) Sampling — DRUG
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2023
Status verified
Aug 2025
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
780 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Maritza Esqueda-Medina
[email protected]
312-563-3702
Amanda R Mathew, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Rush University Medical Center· Chicago, IL

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