NCT06822049

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

Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Remote vs. In-Person
• Remote Visits
• In-person Visits

Interventions

Type	Name	Description
DRUG	Combination Nicotine Replacement Therapy (patch and lozenge)	All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-07-31
• Completion: 2027-02-28
• First posted: 2025-02-12
• Last updated: 2026-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study