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E-cigarettes + Incentives for Smoking Cessation (THRIVE Trial)

N/A
Recruiting
Led By Cara M Murphy, Ph.D.
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
willing to use ENDs for 6 weeks
21 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 4, 6, and 12 weeks follow-up
Awards & highlights

THRIVE Trial Summary

This trial studies the impact of providing e-cigarettes and incentives to overweight/obese smokers to see if it reduces cigarette smoking. Participants will take breath samples and receive incentives for 28 days.

Who is the study for?
This trial is for adults over 21 with a BMI of 25 or higher who smoke at least 5 cigarettes daily and are willing to try vaping e-cigarettes (ENDS) for smoking cessation. They must have a smartphone/tablet, not be pregnant/nursing, not planning to quit smoking soon, nor using ENDS frequently or undergoing other cessation treatments.Check my eligibility
What is being tested?
The study tests if providing electronic nicotine delivery systems (ENDS) and offering money rewards based on breath test results can help overweight/obese smokers cut down. Participants will get risk info about ENDS vs cigarettes, some will receive ENDS for six weeks, and incentives vary by carbon monoxide levels in their breath.See study design
What are the potential side effects?
While the trial description does not specify side effects, common ones associated with using ENDS may include throat/mouth irritation, coughing, nausea, headache or increased heart rate. The impact of contingent incentives on behavior is also being studied but isn't typically associated with physical side effects.

THRIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to use a specific device for 6 weeks.
Select...
I am 21 years old or older.

THRIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 4, 6, and 12 weeks follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 4, 6, and 12 weeks follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Use of Cigarettes and ENDS
Within-Treatment Smoking Abstinence
Secondary outcome measures
Carbon monoxide (CO)
Cigarette and E-Cigarette Dependence
Comparing E-Cigarettes and Cigarettes Questionnaire
+2 more

THRIVE Trial Design

4Treatment groups
Experimental Treatment
Group I: No ENDS and NIExperimental Treatment2 Interventions
Participants in this arm will receive information about the comparative risk of electronic nicotine devices (ENDs) relative to smoking and will receive monetary incentives for providing breath samples only (non-contingent on smoking status).
Group II: No ENDS and CIExperimental Treatment2 Interventions
Participants in this arm will receive information about the comparative risk of electronic nicotine delivery systems (ENDS) relative to smoking and will receive 4 weeks of monetary incentives for complete abstinence from smoking (after a controlled ramp down of smoking).
Group III: ENDS and NIExperimental Treatment2 Interventions
Participants in this arm will receive information about the comparative risk of electronic nicotine delivery systems (ENDS) relative to smoking as well as 6 weeks' worth of provisions of ENDS and will receive monetary incentives for providing breath samples only (non-contingent on smoking status).
Group IV: ENDS and CIExperimental Treatment2 Interventions
Participants in this arm will receive information about the comparative risk of electronic nicotine delivery systems (ENDS) relative to smoking as well as 6 weeks' worth of provisions of ENDS and will receive 4 weeks of monetary incentives for complete abstinence from smoking (after a controlled ramp down of smoking).

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,308 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
247,076 Total Patients Enrolled
Cara M Murphy, Ph.D.Principal InvestigatorBrown University

Frequently Asked Questions

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

How may I join this research venture?

"Eligible individuals must possess a BMI indicative of obesity and be between the ages of 21 to 99. At this time, there is capacity for 36 people to join the study."

Answered by AI

Does this research embrace persons of advanced age as potential participants?

"As per the rules of participation for this clinical trial, participants must be aged 21-99."

Answered by AI

What is the scope of this trial in terms of participant numbers?

"Affirmative. According to clinicaltrials.gov, this medical trial commenced on the 2nd of October 2023 and was last updated on 30th October 2023. It is presently in search of 36 subjects across a single site."

Answered by AI

Are there any positions available in this study right now?

"The clinical trial is presently recruiting, and the information posted on clinicaltrials.gov suggests that this study was first published in October 2nd 2023 and last updated by researchers at the end of month."

Answered by AI

What is the primary purpose of this clinical investigation?

"The primary determination of this trial's success is the ability to sustain smoking abstinence over a four, six, and twelve-week period. Secondary assessments include exhaled breath samples for carbon monoxide levels, self-reported cigarette dependence on the PATH Study questionnaire, and attitudes towards e-cigarettes relative to traditional cigarettes via the CEAC Questionnaire."

Answered by AI

Who else is applying?

What site did they apply to?
Brown University School of Public Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Needed help quitting smoking wanted to try vaping.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Trial for Harm Reduction With Incentives & Vaping E-cigarettes
2023. "Trial for Harm Reduction With Incentives & Vaping E-cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111053.
All > Overweight
~12 spots leftby Jul 2024
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