Obesity Clinical Trial
— THRIVEOfficial title:
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brown University School of Public Health | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Brown University | National Institute of General Medical Sciences (NIGMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Within-Treatment Smoking Abstinence | Number of days during the incentive period with CO verified abstinence from smoking | Daily for 4 weeks | |
Secondary | 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 | |
Secondary | Carbon monoxide (CO) | Exhaled breath sample used to measure carbon monoxide | Assessed 4, 6, and 12 weeks follow-up | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Weight | Measured body weight in pounds | Assessed 4, 6, and 12 weeks follow-up |
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