Clinical trial NCT06111053: Trial for Harm Reduction With Incentives & Vaping E-cigarettes
Official title: Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and E-Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Smoking Cessation
Keywords: obesity
overweight
electronic nicotine delivery systems
contingent incentives
harm reduction
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-11-01
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Use of Cigarettes and ENDS
timeFrame: Assessed 4, 6, and 12 weeks follow-up
measure: Within-Treatment Smoking Abstinence
timeFrame: Daily for 4 weeks
Secondary outcomes:
measure: Motivation to change
timeFrame: Assessed 4, 6, and 12 weeks follow-up
measure: Carbon monoxide (CO)
timeFrame: Assessed 4, 6, and 12 weeks follow-up
measure: Cigarette and E-Cigarette Dependence
timeFrame: Assessed 4, 6, and 12 weeks follow-up
measure: Comparing E-Cigarettes and Cigarettes Questionnaire
timeFrame: Assessed 4, 6, and 12 weeks follow-up
measure: Weight
timeFrame: Assessed 4, 6, and 12 weeks follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Cara M Murphy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: