Trial for Harm Reduction With Incentives & Vaping E-cigarettes

Obesity Clinical Trial

— THRIVE  

Official title:

Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and E-Cigarettes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111053
• Other study ID #: 2022003359
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Brown University
• Contact: Cara M Murphy, Ph.D.
• Phone: 1 (401) 203-5339
• Email: THRIVE[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ENDS) provisions and contingent incentives (CI) on smoking in individuals with overweight/obesity who smoke cigarettes (SWO). All participants will be provided information on the comparative risk of ENDS relative to cigarette smoking, and a randomized group of participants will be provided ENDS provisions for 6 weeks. All participants will complete breath samples for 28 days to measure their exhaled carbon monoxide and will either receive fixed incentives for sample completion or receive varying incentives contingent on their carbon monoxide levels. Researchers will compare groups to understand the effect of each condition on smoking-related behavior.

Description:

Individuals with overweight/obesity who smoke cigarettes (SWO) have greatly increased risks of metabolic, cardiac, and pulmonary diseases due to the synergistic effects of tobacco and obesity. Switching to electronic nicotine delivery systems (ENDS) may decrease the risk of negative health outcomes and be a promising approach for SWO. The purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ENDS) provisions and contingent incentives (CI) on individuals with overweight/obesity who smoke cigarettes (SWO). The primary aim of this study is to examine the effect of ENDS provision on smoking and the effect of the provision of CI provision on smoking. The secondary aims are to assess the effects of ENDS and CI provision on exhaled carbon monoxide (CO), cigarette dependence, intention to quit smoking, and quitting self-efficacy, and to determine whether any changes in weight occurred secondary to the use of ENDS. Evidence of the efficacy of switching to ENDS and the use of CI could be utilized in healthcare settings to reduce the risk of morbidity and mortality among smokers with obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• BMI = 25 kg/m2

• smoked = 5 cigarettes/day during the past year

• 21 or older

• exhaled CO of > 6 ppm at Baseline

• willing to use ENDs for 6 weeks

• daily access to a Bluetooth-enabled smartphone/tablet

Exclusion Criteria:

• planning to set a smoking quit date in the next 30 days

• receiving smoking cessation treatment of any kind in the past 30 days

• currently using ENDS > 4 day per month

• hospitalized for mental illness in past 30 days

• heart-related event (e.g., heart attack, severe angina) in past 30 days

• resides with another person enrolled in the study

• pregnant, nursing, or planning to become pregnant in the next 6 months.

Related Conditions & MeSH terms

• Obesity
• Smoking Cessation

Intervention

Other:
• ENDS
Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.
• CI
Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.
• No ENDS
Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.
• NI
Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Cigarettes and ENDS	Daily use of cigarettes and ENDS will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments post-treatment.	Assessed 4, 6, and 12 weeks follow-up
Primary	Within-Treatment Smoking Abstinence	Number of days during the incentive period with CO verified abstinence from smoking	Daily for 4 weeks
Secondary	Motivation to change	Self-reported motivation, confidence, and importance of changing smoking and other tobacco & nicotine use behavior will be measured using motivation to change rulers	Assessed 4, 6, and 12 weeks follow-up
Secondary	Carbon monoxide (CO)	Exhaled breath sample used to measure carbon monoxide	Assessed 4, 6, and 12 weeks follow-up
Secondary	Cigarette and E-Cigarette Dependence	Self-reported level of dependence on cigarettes and e-cigarettes will be assessed using the Population Assessment of Tobacco and Health (PATH) Study dependence questionnaire. Items on this scale are scored from 1, "Not true of me at all", to 5, "Extremely true of me". Higher scores represent higher levels of cigarette and e-cigarette dependence. Minutes to first cigarettes daily will also be used to assess cigarette dependence with lower scores indicating greater cigarette dependence.	Assessed 4, 6, and 12 weeks follow-up
Secondary	Comparing E-Cigarettes and Cigarettes Questionnaire	Attitudes towards e-cigarettes relative to cigarettes (i.e., general benefits, general effects, and health benefits), will be assessed using the Comparing E-Cigarette and Cigarettes (CEAC) Questionnaire. Items on this questionnaire are scored from 1, "Strongly Disagree", to 5, "Strongly Agree" with higher score indicating greater agreement with benefits of e-cigarettes relative to cigarettes.	Assessed 4, 6, and 12 weeks follow-up
Secondary	Weight	Measured body weight in pounds	Assessed 4, 6, and 12 weeks follow-up