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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months - no longer in use after 7/6/2020
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months - no longer in use after 7/6/2020
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 • NCT0317678430%
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
~7450
Counseling
2017
Completed Phase 4
~1970
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,197,805 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be able to speak either English or Spanish.I have smoked at least once in the past 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Long, Short, Present
- Group 2: Short, Short, Absent
- Group 3: Long, Long, Present
- Group 4: Long, Short, Absent
- Group 5: Short, Short, Present
- Group 6: Short, Long, Absent
- Group 7: Short, Long, Present
- Group 8: Long, Long, Absent
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Smoking Patient Testimony for trial: Trial Name: NCT03611881 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What past investigations have scrutinized the efficacy of Nicotine patch therapies?
"Currently, 71 medical trials are actively researching the use of Nicotine patch with 5 studies in a Phase 3 state. Most of these research sites are based near Green Bay, Wisconsin but 204 locations worldwide have set up clinical trails for this medication."
Answered by AI
Are minors being included in the scope of this experiment?
"To be eligible for this medical trial, applicants need to fall within the age bracket of 50-80 years old. As an aside, 8 studies are available for those below 18 and 86 for those above 65."
Answered by AI
What is the current number of enrollees for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this study was initially posted on April 8th 2019 and has been actively recruiting since then. 640 patients from 7 distinct sites are currently being sought out for the trial."
Answered by AI
Are there any criteria that individuals must meet in order to participate in this research?
"This research programme is recruiting 640 individuals aged between 50 and 80 who have used tobacco in the last 30 days. To be considered eligible for this trial, participants must also meet additional criteria such as being a current smoker."
Answered by AI
Are there any vacancies left to join this clinical trial?
"Clinicaltrials.gov declares that this experiment is currently searching for participants, with the original posting taking place on 8th April 2019 and most recently revised on 1st March 2022."
Answered by AI
Has the Nicotine patch been granted approval from the FDA?
"After careful consideration, the safety of Nicotine patch was rated a 3 due to its Phase 4 status and existing approval."
Answered by AI
In what Canadian regions is this research venture being conducted?
"Seven medical centres are currently offering this clinical trial - including Salem Hospital, Martha's Vineyard Hospital, and Brigham & Women’s Hospital. Moreover, there is availability at four other institutions."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
Brigham & Women's Faulkner Hospital
Salem Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I hate smoking. I've tried so many times to quit with no luck.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Most responsive sites:
- Brigham and Women's Hospital: < 24 hours
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