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

Last updated: January 12, 2026
Sponsor: State University of New York at Buffalo
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Combination Nicotine Replacement Therapy (patch and lozenge)

Clinical Study ID

NCT06822049
STUDY00008797 (SUNY-Buff IRB)
1UG3TR004797-01A1
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Common to all 3 RCTs:

Inclusion criteria:

  1. age18+ years

  2. stable mailing address (for mailing study packets if assigned to Remote Intakeand/or Remote Treatment/Assessment) within accessible range (1.5 hours) of eachstudy 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 textmessages (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

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 3months b) prior allergy/intolerance to NRT patch or lozenge c). pregnant,breastfeeding, or planning to become pregnant in next 4 months d) use ofvarenicline, NRT (e.g., patch, gum, lozenge), or bupropion in past 7 days forpurpose of quitting smoking e) consumption of >28 alcohol-containing drinks per weekg) 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 majordepression) that led to hospitalization in the past 30 days j) unable/unwilling toprovide informed consent or follow directions, inappropriately responsive, based onstaff observations k) for participants age 21+: refusal to provide/show a pack ofcigarettes for documentation at the intake visit

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Combination Nicotine Replacement Therapy (patch and lozenge)
Phase: 2/3
Study Start date:
March 10, 2025
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • University at Buffalo

    Buffalo, New York 14260
    United States

    Site Not Available

  • University at Buffalo

    Buffalo 5110629, New York 5128638 14260
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

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