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The RISE Above Smoking trial explores the impact of remote and in-person treatment settings on participants' ability to attend study sessions and adhere to treatment and study protocols. Participants are recruited based on their desire to quit smoking and are provided an 8-week course of dual nicotine replacement therapy while meeting with study staff for a total of 6 sessions in a 4-month period. The trial's experimental core is the 2-stage randomization process. Eligible participants are first randomized to attend either a remote or in-person intake session and then randomized again at intake to determine whether their remaining 5 sessions will take place remotely or in-person. The resultant 4-cell design allows for a balanced and rigorous assessment of the differences between participant accrual, retention, treatment adherence, and biospecimen collection in remote versus in-person settings.
Clinicaltrials.gov ID: NCT06822049
Current IRB Protocol
Consent Form
Protocol Paper: Under Review
These are all of the forms used in the Trials
Phone Screen
TLFB Setup
TLFB
Medication Accountability Form
Smoking History and Demographics
FTCD
QSU Phenx
MNWS Phenx
TOEs and AbstSE
Cost Measure
Quit Kit
Perceived Stress Scale
SE Checklist V20
Continuing Quit Strategies
Medications
Intake Breath Co
Breathco
Px270401 Phenx Health Literacy
Phenx Health Literacy for Participant
CPQ-12 - Computer Proficiency Questionnaire
MDPQ-16
Trust Medical Care Research 4 Item
Discrimination Health Care
AUDIT
PHQ 8
NIDA QS1
Study Status
Visit Status
Contact Log
Contact Info
Phone Screen Eligibility Summary
Randomization for Intake
Intake Info
Text Invitation Form
Intake Record Form
Participant Consent
Staff Consent
Consent Overview
T/A 1 Record Form
T/A 2 Record Form
T/A 3 Record Form
T/A 4 Record Form
T/A 5 Record Form
Side Effect Tracking
Ad Hoc AEs
Intake Eligibility Summary
Randomization 2 at Intake
T/A Visit Scheduler
Post-Intake Record Form
Post T/A Record Form
Meta Screen
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