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Financial Incentives for Smoking Cessation

Q: How many participants is this experiment limited to?

Affirmative. According to information given on clinicaltrials.gov, this research study is currently recruiting participants from one site and aims to enroll 400 individuals. This trial was first posted in June 2021 and recently updated in March 2022.

Q: What other research efforts have been devoted to examining the effectiveness of Varenicline?

Presently, there are 26 ongoing studies exploring the use of Varenicline with 4 trials in their final phase. Most experiments for this drug are conducted from Charleston, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> though 69 other locations have joined to contribute data as well.

Q: Are there still openings for participants in this clinical research?

Per clinicaltrials.gov, this research is presently accepting participants with the initial posting on June 10th 2021 and most recently updated on March 3rd 2022.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cotinine-verified 7-day smoking abstinence at 12 weeks

Secondary outcome measures

Cotinine-verified 7-day smoking abstinence at 24 weeks

Other outcome measures

Cotinine

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Depression

21%

Agitation

21%

Headache

14%

Allergies

14%

Heartburn

14%

Cold

14%

Back Pain

Cellulitis

Sinusitis

Stomach Pain

Panic

Angina

Aggression

Palpitations

Rash

Confusion

Dizziness

Fatigue

Leg Spasms

Increased Blood Pressure

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

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

~26020

Varenicline

2011

Completed Phase 4

~4170

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,934 Previous Clinical Trials

13,198,401 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,925,952 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,670 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this experiment limited to?

"Affirmative. According to information given on clinicaltrials.gov, this research study is currently recruiting participants from one site and aims to enroll 400 individuals. This trial was first posted in June 2021 and recently updated in March 2022."

Answered by AI

What other research efforts have been devoted to examining the effectiveness of Varenicline?

"Presently, there are 26 ongoing studies exploring the use of Varenicline with 4 trials in their final phase. Most experiments for this drug are conducted from Charleston, South carolina though 69 other locations have joined to contribute data as well."

Answered by AI

Are there still openings for participants in this clinical research?

"Per clinicaltrials.gov, this research is presently accepting participants with the initial posting on June 10th 2021 and most recently updated on March 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Financial Incentives for Homeless Smokers: A Community-based RCT

Travis Paul Baggett 2021. "Financial Incentives for Homeless Smokers: A Community-based RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04445662.

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