My Path to Quit Tobacco
ConditionSmoking Cessation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Wisconsin, Madison
About this trial
The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
self-identify as Black
smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
motivated to quit smoking
willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
Disqualifiers
currently taking bupropion for non-smoking cessation reasons
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotine patch
DrugPatch dosing will be consistent with the package insert
Quitline Counseling Phone Calls
Other intervention4, 10 to 15-minute counseling sessions (the duration of a typical quitline call) will occur via phone one week prior to the TQD, 1 day after the TQD, and 1 and 2 weeks after the TQD.
Counseling Sessions
Other interventionParticipants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions
Pathways to Freedom
Other interventionPathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt.
Monetary Incentive
Other interventionup to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
Treatment groups
1,550 Participants
are divided into 3 treatment groupsGroup A: Standard InterventionActive comparator 2 interventions
Group B: Intensive InterventionExperimental treatment 3 interventions
Group C: Intensive Incentivized InterventionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng/ml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD
Time frame
26 weeks post-TQDSecondary outcomes
1
Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day
salivary cotinine using a cut-off of less than 10 ng/ml to indicate abstinence from any nicotine product (combusted cigarettes, e-cigarettes, nicotine replacement therapy \[NRT\])
Time frame
26 weeks post-TQD2
Treatment Satisfaction
Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.
Time frame
8 weeks post-TQD3
Cigarettes per day
Cigarettes per day based on the past 7 days.
Time frame
baseline, 8 and 26 weeks post-TQD4
Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)
Scores range from 0 to 100 where higher scores indicate better quality of life.
Time frame
baseline, 8 and 26 weeks post-TQDSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov