Trial for Harm Reduction With Incentives & Vaping E-cigarettes (THRIVE)

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Brown University

Status

Enrolling

Conditions

Obesity
Smoking Cessation

Treatments

Other: No ENDS
Other: CI
Other: NI
Other: ENDS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06111053
2022003359

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

21 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

36 participants in 4 patient groups

ENDS and CI
Experimental group
Description:
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).
Treatment:
Other: ENDS
Other: CI
No ENDS and CI
Experimental group
Description:
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).
Treatment:
Other: CI
Other: No ENDS
ENDS and NI
Experimental group
Description:
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).
Treatment:
Other: ENDS
Other: NI
No ENDS and NI
Experimental group
Description:
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).
Treatment:
Other: NI
Other: No ENDS

Trial contacts and locations

0

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Central trial contact

Cara M Murphy, Ph.D.

Data sourced from clinicaltrials.gov

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