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Financial Incentives for Smoking Cessation

N/A
Recruiting
Led By Travis Baggett, 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
Age ≥18 years old
Be older than 18 years old
Must not have
Past-month suicidal ideation with plan or intent, or past 12-month history of suicidal behaviors or attempts
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if giving homeless smokers money will help them quit smoking. People in the study will be given money if they can prove they haven't been smoking, 10 times over 12 weeks. They will also be interviewed about their experiences.

Who is the study for?
This trial is for English-speaking adults over 18 who smoke at least 5 cigarettes daily and have smoked over 100 in their lifetime. They must be currently or formerly homeless, ready to quit smoking soon, and have a primary care provider within the BHCHP system. People with recent severe mental health issues, current pregnancy or breastfeeding, or allergies to varenicline cannot join.
What is being tested?
The study tests if financial rewards can help homeless smokers quit. Participants will get stop-smoking support like varenicline and coaching. Some will also receive money when they show lower nicotine levels in saliva tests over three months.
What are the potential side effects?
Varenicline may cause nausea, sleep problems, constipation, gas, vomiting; changes in taste; dry mouth; headaches; sweating; skin rashes; seizures (rare); heart or blood vessel problems (rare).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have thought about or attempted suicide in the past year.
Select...
I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cotinine-verified 7-day smoking abstinence at 12 weeks
Secondary study objectives
Cotinine-verified 7-day smoking abstinence at 24 weeks
Other study objectives
Cotinine

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Financial incentives (n=90)Experimental Treatment3 Interventions
* Varenicline * Tobacco coaching * Saliva cotinine monitoring with escalating payments ($25-70) for levels \<30 ng/ml
Group II: Control (n=90)Active Control2 Interventions
* Varenicline * Tobacco coaching * Saliva cotinine monitoring with fixed payments ($10) regardless of results
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Financial incentives
2018
Completed Phase 3
~26150
Varenicline
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,102 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,869 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,452 Total Patients Enrolled

Media Library

Financial incentives Clinical Trial Eligibility Overview. Trial Name: NCT04445662 — N/A
Tobacco Smoking Research Study Groups: Financial incentives (n=90), Control (n=90)
Tobacco Smoking Clinical Trial 2023: Financial incentives Highlights & Side Effects. Trial Name: NCT04445662 — N/A
Financial incentives 2023 Treatment Timeline for Medical Study. Trial Name: NCT04445662 — N/A
~42 spots leftby Nov 2025
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