Clinical trial NCT05513872: Overcoming Nicotine Dependence to Enable Quitting
Official title: A Mechanistic Test of Treatment Strategies to Foster Practice Quitting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tobacco Use
Smoking Cessation
Smoking Behaviors
Nicotine Dependence
Nicotine Withdrawal
Keywords: tobacco
smoking cessation
nicotine dependence
nicotine replacement therapy
behavioral treatment
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2022-08-24
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Any incidence of a quit attempt
timeFrame: At 6-month follow-up assessment
Secondary outcomes:
measure: Abstinence status at 1-month follow-up
timeFrame: At 1-month follow-up assessment
measure: Abstinence status at 3-month follow-up
timeFrame: At 3-month follow-up assessment
measure: Abstinence status at 6-month follow-up
timeFrame: At 6-month follow-up assessment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Amanda Mathew, PhD
role: PRINCIPAL_INVESTIGATOR
References: