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NCT Number: NCT06822049

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University at Buffalo, Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Common to all 3 RCTs:

Inclusion criteria

  • age18+ years
  • 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)
  • able to read, speak & verbally comprehend English
  • own an iOS or Android smartphone
  • 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, spliffs, cigars, little cigars, cigarillos) for average of 5_ days per week over the past 3 months b) prior allergy/intolerance to NRT patch or lozenge c). pregnant, breastfeeding, or planning to become pregnant in next 4 months d) use of varenicline, NRT (e.g., patch, gum, lozenge), or bupropion in past 7 days for purpose of quitting smoking e) consumption of >28 alcohol-containing drinks per week g) high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST=27+) h) suicide attempt with at least some wish to die in past 3 months i) mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days j) unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations k) for participants age 21+: refusal to provide/show a pack of cigarettes for documentation at the intake visit

Treatment and study plan

Combination Nicotine Replacement Therapy (patch and lozenge)

Drug

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

Primary outcomes

  1. Accrual efficiency/Pre-treatment visits

    Time frame: ~1 month

    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.

  2. Trial Quality: Retention

    Time frame: ~3 months

    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.

  3. Trial Quality: Treatment adherence/utilization (patient-reported)

    Time frame: 8 weeks (assessed at T/A Visits 3, 4, and 5)

    As in most studies in the smoking cessation clinical trial literature, we will assess self-reported patch and lozenge use since the previous visit and convert the data to percent adherence separately for patches and lozenges. Pharmacotherapy is initiated at T/A Visit 2; therefore treatment adherence is assessed at T/A Visits 3, 4, and 5).

  4. Trial quality: Biospecimen completion rates

    Time frame: 3 months (assessed at T/A Visits 1,2, 3, 4, and 5)

    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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Abramson Cancer Center at Penn Medicine
  • Medical University of South Carolina
  • National Center for Advancing Translational Sciences (NCATS)
  • University of Alabama at Birmingham
  • University of Pennsylvania
  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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