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

NCT06822049 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Abramson Cancer Center at Penn Medicine

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • State University of New York at Buffalo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-07-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822049 on ClinicalTrials.gov