Clinical trial NCT06822049: Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)
Official title: Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Remote vs. In-Person
Remote Visits
In-person Visits
Keywords: Remote vs. In-Person methods
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: University of Pennsylvania
name: University of Alabama at Birmingham
name: National Center for Advancing Translational Sciences (NCATS)
name: Abramson Cancer Center at Penn Medicine
First posted: 2025-02-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel-group design, with two-stage randomization
Primary purpose: OTHER

Brief 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 criteria: 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

Primary outcomes:
measure: Accrual efficiency/Pre-treatment visits
timeFrame: ~1 month
measure: Trial Quality: Retention
timeFrame: ~3 months
measure: Trial Quality: Treatment adherence/utilization (patient-reported)
timeFrame: 8 weeks (assessed at T/A Visits 3, 4, and 5)
measure: Trial quality: Biospecimen completion rates
timeFrame: 3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: