Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1 of 3)

In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.

All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.

In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.

All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.

In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.

All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.

In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.

All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.

Calculated from visit milestones. Of participants who were eligible on the Brief Screen, the percentage who who attend the (Remote vs. In-Person) Intake Visit, a major accrual bottleneck for in-person trials. Although pre-treatment participant loss from Intake to Clinic 1 is typically modest, we will also explore Intake to T/A Visit 1 (first dose of treatment) attrition and overall pre-treatment attrition (from Brief Screen to T/A Visit 1) for each group.

Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.

Participants are instructed to use NRT patch and lozenge for 8 weeks, beginning on the date of T/A Visit 2 and ending the day before T/A Visit 4. Medication adherence will be assessed at T/A Visits 3 and 4 (end of NRT weeks 3 & 8). Though we originally proposed to assess NRT use since the prior visit, we noted early in the trial that these data were problematic, as participants received their 2nd batch of medication before completing the 1st and often intermixed them. We decided to focus on past 7-day timeline followback (TLFB) interview reporting of NRT use: whether (yes/no) a patch was worn each day and number of lozenges used each day. From these data, we will compute for each participant the percent of days a nicotine patch was worn and the percent of days on which participants used 5+ lozenges (we recommended using 5+/day). A supplementary analysis will examine average number of lozenges per day.

The number of visits (out of 5; T/A Visits 1-5) for which the biospecimen (expired-air CO) is obtained by the clinical site.