Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and E-Cigarettes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brown University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Within-Treatment Smoking Abstinence
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessor will not know the outcome of randomized assignment.
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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).
Intervention: ENDS (Other)
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).
Intervention: CI (Other)
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).
Intervention: CI (Other)
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).
Intervention: No ENDS (Other)
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).
Intervention: ENDS (Other)
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).
Intervention: NI (Other)
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).
Intervention: No ENDS (Other)
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).
Intervention: NI (Other)
Outcomes
Primary Outcomes
Within-Treatment Smoking Abstinence
Time Frame: Daily for 4 weeks
Number of days during the incentive period with CO verified abstinence from smoking
Use of Cigarettes and ENDS
Time Frame: Assessed 4, 6, and 12 weeks follow-up
Daily use of cigarettes and ENDS will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments post-treatment.
Secondary Outcomes
- Comparing E-Cigarettes and Cigarettes Questionnaire(Assessed 4, 6, and 12 weeks follow-up)
- Carbon monoxide (CO)(Assessed 4, 6, and 12 weeks follow-up)
- Motivation to change(Assessed 4, 6, and 12 weeks follow-up)
- Cigarette and E-Cigarette Dependence(Assessed 4, 6, and 12 weeks follow-up)
- Weight(Assessed 4, 6, and 12 weeks follow-up)