RecruitingNCT07419425ClinicalTrials.gov record

My Path to Quit Tobacco

Smoking Cessation

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 4
Age range: 21 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 1550 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke.

Secondary Objectives:

Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD)
Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes.
Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

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.

Exclusion Criteria:

currently taking bupropion for non-smoking cessation reasons

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Single masked

Standard Intervention

The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.

Drug: Nicotine patch · Other: Quitline Counseling Phone Calls

Intensive Intervention

The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content.

Drug: Nicotine patch · Other: Counseling Sessions · Other: Pathways to Freedom

Intensive Incentivized Intervention

The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)

Drug: Nicotine patch · Other: Counseling Sessions · Other: Pathways to Freedom · Other: Monetary Incentive

Nicotine patch DRUG

Patch dosing will be consistent with the package insert

Quitline Counseling Phone Calls OTHER

4, 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

Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions

Pathways to Freedom OTHER

Pathways 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

up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day

Time frame: 26 weeks post-TQD

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

Secondary measures

Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day

Time frame: 26 weeks post-TQD

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 \[NRT\])

Treatment Satisfaction

Time frame: 8 weeks post-TQD

Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.

Cigarettes per day