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Tobacco Cessation Interventions for Smoking Cessation (ScreenASSIST Trial)

Phase 4
Waitlist Available
Led By Nancy A Rigotti, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months - no longer in use after 7/6/2020
Awards & highlights

ScreenASSIST Trial Summary

This trial is testing different ways to help people quit smoking, using LDCT lung cancer screenings as an opportunity.

Who is the study for?
This trial is for current smokers aged 50-80 who speak English or Spanish, have smoked recently, are scheduled for a low-dose CT lung cancer screening, and live in the USA. They must be able to give consent and communicate by phone. Those with certain medical conditions or without telephone access cannot join.Check my eligibility
What is being tested?
The study tests how best to integrate smoking cessation help into lung cancer screenings. Participants will receive different lengths of counseling (via phone/video) and nicotine patch treatments, plus some may get referred to online community resources.See study design
What are the potential side effects?
Possible side effects from the nicotine patch can include skin irritation at the patch site, dizziness, racing heartbeat, sleep problems or unusual dreams, headache, nausea, muscle pain and stiffness.

ScreenASSIST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months - no longer in use after 7/6/2020
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months - no longer in use after 7/6/2020 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Proportion of patients who make an intentional attempt to quit smoking
Proportion of patients with >50% reduction in cigarettes smoked per day
Self-reported past 7-day smoking abstinence
Other outcome measures
Biochemically-verified past 7-day abstinence from cigarette smoking

Side effects data

From 2020 Phase 4 trial • 1251 Patients • NCT03176784
30%
Nausea
30%
Insomnia
17%
Skin Rash
16%
Changes in Mood
13%
Itching/Hives
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Varenicline + Patch Standard Duration
Varenicline + Patch Extended Duration
Varenicline Only Standard Duration
Varenicline Only Extended Duration

ScreenASSIST Trial Design

8Treatment groups
Experimental Treatment
Group I: Short, Short, PresentExperimental Treatment3 Interventions
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Group II: Short, Short, AbsentExperimental Treatment2 Interventions
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Group III: Short, Long, PresentExperimental Treatment3 Interventions
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Group IV: Short, Long, AbsentExperimental Treatment2 Interventions
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Group V: Long, Short, PresentExperimental Treatment3 Interventions
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Group VI: Long, Short, AbsentExperimental Treatment2 Interventions
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Group VII: Long, Long, PresentExperimental Treatment3 Interventions
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Group VIII: Long, Long, AbsentExperimental Treatment2 Interventions
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine patch
2015
Completed Phase 4
~7330
Counseling
2017
Completed Phase 4
~1940
Community Resource
2019
Completed Phase 4
~650

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,347 Total Patients Enrolled
Nancy A Rigotti, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
4,590 Total Patients Enrolled
Elyse R Park, PhDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
516 Total Patients Enrolled

Media Library

Counseling Clinical Trial Eligibility Overview. Trial Name: NCT03611881 — Phase 4
Tobacco Smoking Research Study Groups: Long, Short, Present, Short, Short, Absent, Long, Long, Present, Long, Short, Absent, Short, Short, Present, Short, Long, Absent, Short, Long, Present, Long, Long, Absent
Tobacco Smoking Clinical Trial 2023: Counseling Highlights & Side Effects. Trial Name: NCT03611881 — Phase 4
Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT03611881 — Phase 4
Tobacco Smoking Patient Testimony for trial: Trial Name: NCT03611881 — Phase 4
~106 spots leftby Jun 2025
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