Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)
Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials
State University of New York at Buffalo
200 participants
Mar 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Common to all 3 RCTs:
- 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:
- 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 Criteria2
- 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
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Interventions
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06822049