Trial for Harm Reduction With Incentives & Vaping E-cigarettes (THRIVE)

Brown University

Status: Enrolling

Conditions: Obesity; Smoking Cessation

Treatments: Other: No ENDS; Other: CI; Other: NI; Other: ENDS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06111053

2022003359

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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36 participants in 4 patient groups

ENDS and CI

Experimental group

Description:

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).

Treatment:

Other: ENDS

Other: CI

No ENDS and CI

Experimental group

Description:

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).

Treatment:

Other: CI

Other: No ENDS

ENDS and NI

Experimental group

Description:

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).

Treatment:

Other: ENDS

Other: NI

No ENDS and NI

Experimental group

Description:

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).

Treatment:

Other: NI

Other: No ENDS