Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)
Running, not enrolling · Phase 2/Phase 3
Conditions studied: Remote vs. In-Person, Remote Visits, In-person Visits
In brief
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.
Key facts
- Study ID
- NCT06822049
- Run by
- State University of New York at Buffalo
- People needed
- 200
- Starts
- 2025-03-10
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University at Buffalo — Buffalo, New York, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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