Trial for Harm Reduction With Incentives & Vaping E-cigarettes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Smoking Cessation

Intervention / Treatment
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* Other: ENDS
* Other: CI
* Other: No ENDS
* Other: NI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: A 2x2 factorial design comparing contingent incentives (CI) for smoking abstinence to noncontingent incentives (NI) the provision of ENDS (ENDS) to no provision of ENDS (No ENDS) SWO (N=36) will be randomized to receive 4 weeks of monetary incentives contingent on their smoking abstinence (CI) or after completing breath samples only (NI). They will also be randomized to receive either a 6-week provision of ENDS with information communicating the comparative risk of ENDS use relative to smoking or information communicating the comparative risk of ENDS relative to smoking without ENDS provision. Conditions are as follows: C1: ENDS + CI C2: NoENDS + CI C3: ENDS + NI C4: NoENDS + NI
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENDS and CI<br>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<br>* Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.<br>* Other names: Electronic Nicotine Delivery Systems;Other: CI<br>* Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.<br>* Other names: Contingent Incentives;|
| Experimental: No ENDS and CI<br>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<br>* Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.<br>* Other names: Contingent Incentives;Other: No ENDS<br>* Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.<br>|
| Experimental: ENDS and NI<br>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<br>* Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.<br>* Other names: Electronic Nicotine Delivery Systems;Other: NI<br>* Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.<br>* Other names: Non-Contingent Incentives;|
| Experimental: No ENDS and NI<br>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<br>* Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.<br>Other: NI<br>* Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.<br>* Other names: Non-Contingent Incentives;|

What is the study measuring?
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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 | 
| 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 | 
| Weight | Measured body weight in pounds | Assessed 4, 6, and 12 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, electronic nicotine delivery systems, contingent incentives, harm reduction