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Recruiting Phase 2, Phase 3 NCT06822049

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

Trial Parameters

Condition Remote vs. In-Person
Sponsor State University of New York at Buffalo
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2025-03-10
Completion 2026-07-31
Interventions
Combination Nicotine Replacement Therapy (patch and lozenge)

Brief Summary

The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.

Eligibility Criteria

Inclusion Criteria: * Common to all 3 RCTs: Inclusion criteria: 1. age18+ years 2. stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report) 3. able to read, speak \& verbally comprehend English 4. own an iOS or Android smartphone 5. have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments) Specific to RCT 1: Inclusion criteria: a) daily cigarette smoker of 5+ cigarettes/day for 6+ months b) moderate or greater motivation to quit smoking (6+ on the Motivation to Stop Smoking Scale) d) agree to refrain from use of other tobacco products and use of non-study cessation treatments while participating in the trial e) Willing to be randomized to attend remote/in-person visits Exclusion Criteria: * Specific to RCT 1: a) use of tobacco/nicotine products other than cigarettes (except blunts, spliff

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