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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06111053
Other study ID # 2022003359
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Brown University
Contact Cara M Murphy, Ph.D.
Phone 1 (401) 203-5339
Email THRIVE@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ENDS
Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.
CI
Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.
No ENDS
Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.
NI
Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.

Locations

Country Name City State
United States Brown University School of Public Health Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

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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