Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)
NCT ID: NCT06822049
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2025-03-10
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The study employs a two-stage adaptive biased-coin randomization technique. The initial randomization will be generated using a stratified biased coin design with an allocation probability of 0.75 and a randomization list within each stratum will be generated for both Stage I (randomization to remote vs in-person Intake) and Stage II (randomization to remote vs. in-person Treatment/Assessment visits). To optimize the balance in cell sizes across the 4 treatment conditions, the allocation probabilities will be adjusted at 3 study milestones (once 25%, 50%, and 75% of the target sample of 200 participants attend Treatment/Assessment Visit 1). Specifically, the allocation probability will be modified based on the imbalance in the number of participants across conditions who have attended Treatment/Assessment Visit 1.
OTHER
NONE
Study Groups
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REMOTE intake AND REMOTE treatment/assessment
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
Combination Nicotine Replacement Therapy (patch and lozenge)
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
REMOTE intake BUT IN-PERSON treatment/assessment
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
Combination Nicotine Replacement Therapy (patch and lozenge)
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
IN-PERSON intake, BUT REMOTE treatment/assessment
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
Combination Nicotine Replacement Therapy (patch and lozenge)
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
IN-PERSON intake AND IN-PERSON treatment/assessment
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
Combination Nicotine Replacement Therapy (patch and lozenge)
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
Interventions
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Combination Nicotine Replacement Therapy (patch and lozenge)
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
Eligibility Criteria
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Inclusion Criteria
1. age18+ years
2. 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)
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:
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 Criteria
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
18 Years
99 Years
ALL
Yes
Sponsors
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Medical University of South Carolina
OTHER
University of Pennsylvania
OTHER
University of Alabama at Birmingham
OTHER
National Center for Advancing Translational Sciences (NCATS)
NIH
Abramson Cancer Center at Penn Medicine
OTHER
State University of New York at Buffalo
OTHER
Responsible Party
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Larry Hawk, Ph.D.
professor
Locations
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University at Buffalo
Buffalo, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00008797 (SUNY-Buff IRB)
Identifier Type: -
Identifier Source: org_study_id
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