Trial for Harm Reduction With Incentives & Vaping E-cigarettes

Not Applicable

Completed

• Conditions: Obesity; Smoking Cessation
• Interventions: Other: ENDS; Other: No ENDS; Other: NI; Other: CI

• Registration Number: NCT06111053
• Lead Sponsor: Brown University

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-30
• Study Start: 2023-11-01
• Study First Posted: 2023-11-01
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ENDS and CI	ENDS	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).
No ENDS and NI	NI	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).
ENDS and CI	CI	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).
ENDS and NI	ENDS	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).
ENDS and NI	NI	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).
No ENDS and NI	No ENDS	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).
No ENDS and CI	CI	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).
No ENDS and CI	No ENDS	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).

Primary Outcome Measures

Name	Time	Method
Within-Treatment Smoking Abstinence	Daily for 4 weeks	Number of days during the incentive period with CO verified abstinence from smoking
Use of Cigarettes and ENDS	Assessed 4, 6, and 12 weeks follow-up	Daily use of cigarettes and ENDS will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments post-treatment.

Secondary Outcome Measures

Name	Time	Method
Comparing E-Cigarettes and Cigarettes Questionnaire	Assessed 4, 6, and 12 weeks follow-up	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.
Carbon monoxide (CO)	Assessed 4, 6, and 12 weeks follow-up	Exhaled breath sample used to measure carbon monoxide
Motivation to change	Assessed 4, 6, and 12 weeks follow-up	Self-reported motivation, confidence, and importance of changing smoking and other tobacco \& nicotine use behavior will be measured using motivation to change rulers
Cigarette and E-Cigarette Dependence	Assessed 4, 6, and 12 weeks follow-up	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.
Weight	Assessed 4, 6, and 12 weeks follow-up	Measured body weight in pounds

Trial Locations

Locations (1)

Brown University School of Public Health; 🇺🇸 Providence, Rhode Island, United States