Overcoming Nicotine Dependence to Enable Quitting
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
are pregnant/breastfeeding
had recent cardiovascular trauma such as myocardial infarction
had a stroke within the past 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotine Replacement Therapy (NRT) Sampling
DrugParticipants 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
BehavioralPractice 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
BehavioralMotivational 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.
Treatment groups
780 Participants
are divided into 4 treatment groupsGroup A: Condition #1Experimental treatment 2 interventions
Group B: Condition #2Experimental treatment 1 intervention
Group C: Condition #3Experimental treatment 2 interventions
Group D: Condition #4Experimental treatment 1 intervention
Trial outcomes
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
Time frame
At 6-month follow-up assessmentSecondary outcomes
1
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).
Time frame
At 1-month follow-up assessment2
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).
Time frame
At 3-month follow-up assessment3
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).
Time frame
At 6-month follow-up assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rush University Medical Center
Lead sponsor
Medical University of South Carolina
Collaborator
Source ClinicalTrials.gov