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

Description

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Remote vs. In-Person
Intervention / Treatment

-

Contacts and Locations

Buffalo

University at Buffalo, Buffalo, New York, United States, 14260

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Common to all 3 RCTs:
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

State University of New York at Buffalo,

Study Record Dates

2027-02-28