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

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

Recruiting
18-99 years
All
Phase 2/3

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Overview

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

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 Intake and/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 text messages (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 Smoking Scale63
  3. willingness to use dual NRT to quit
  4. agree to refrain from use of other tobacco products and use of non-study cessation treatments while participating in the trial

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

NCT06822049

State University of New York at Buffalo

31 May 2025

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