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

Last updated: May 23, 2025
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. age >18 years

  2. stable mailing address (for mailing study packets if assigned to Remote Intakeand/or Remote Treatment/Assessment) within accessible range of each study site

  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:

  1. daily cigarette smoker of >5 cigs/day

  2. moderate or greater motivation to quit smoking (6+ on the Motivation to Stop SmokingScale63

  3. willingness to use dual NRT to quit

  4. agree to refrain from use of other tobacco products and use of non-study cessationtreatments while participating in the trial

Exclusion

Exclusion Criteria:

  • Specific to RCT 1:

  1. use of tobacco/nicotine products other than cigarettes more than once per week

  2. prior allergy/intolerance to NRT patch or lozenge

  3. FDA-specified contraindications for use of NRT

  4. use of tobacco/nicotine products other than cigarettes more than once per week

  5. prior allergy/intolerance to NRT patch or lozenge

  6. FDA-specified contraindications for use of NRT

  7. . pregnant, breastfeeding, or planning to become pregnant

  8. self-reported recent (past 1 month) cardiovascular event: MI, stroke

  9. current use of any smoking cessation medication or antipsychotic medication

  10. daily/near-daily binge drinking or alcohol dependence (NIDA Quick Screen;AUDIT>15)

  11. high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST>=27)

  12. past-year suicide attempt

  13. active and unstable major medical/psychiatric conditions

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

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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