NCT06111053

Trial for Harm Reduction With Incentives & Vaping E-cigarettes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity
• Smoking Cessation

Interventions

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

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2023-11-01
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States