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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Obesity
• Intervention / Treatment: Other: ENDS; Other: CI; Other: No ENDS; Other: NI

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENDS and 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).	Other: ENDS; Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.; Other Names: Electronic Nicotine Delivery Systems; 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 Names: Contingent Incentives
Experimental: No ENDS and 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).	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 Names: Contingent Incentives; 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.
Experimental: ENDS and 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).	Other: ENDS; Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.; Other Names: Electronic Nicotine Delivery Systems; Other: NI; Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.; Other Names: Non-Contingent Incentives
Experimental: No ENDS and 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).	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.; Other Names: Non-Contingent Incentives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Within-Treatment Smoking Abstinence	Number of days during the incentive period with CO verified abstinence from smoking	Daily for 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Carbon monoxide (CO)	Exhaled breath sample used to measure carbon monoxide	Assessed 4, 6, and 12 weeks follow-up
Weight	Measured body weight in pounds	Assessed 4, 6, and 12 weeks follow-up
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
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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Cara M Murphy, Ph.D., Brown University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: obesity; overweight; harm reduction; electronic nicotine delivery systems; contingent incentives
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2022003359; P20GM130414 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be kept and used for future research on chronic disease and substance use.
• IPD Sharing Time Frame: Clinical Laboratory Core data collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication with no prespecified end date.
• IPD Sharing Access Criteria: After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No