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Completed

NCT Number: NCT06111053

Trial for Harm Reduction With Incentives & Vaping 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.

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Key information

Conditions

Obesity Behavior Body Weight Harm Reduction Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking Smoking Cessation Vaping

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ENDS

Other

Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.

Other names: Electronic Nicotine Delivery Systems

CI

Other

Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.

Other names: Contingent Incentives

No ENDS

Other

Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.

NI

Other

Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.

Other names: Non-Contingent Incentives

Primary outcomes

  1. 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.

  2. Within-Treatment Smoking Abstinence

    Time frame: Daily for 4 weeks

    Number of days during the incentive period with CO verified abstinence from smoking

Secondary outcomes

  1. Motivation to change

    Time frame: Assessed 4, 6, and 12 weeks follow-up

    Self-reported motivation, confidence, and importance of changing smoking and other tobacco & nicotine use behavior will be measured using motivation to change rulers

  2. Carbon monoxide (CO)

    Time frame: Assessed 4, 6, and 12 weeks follow-up

    Exhaled breath sample used to measure carbon monoxide

  3. Cigarette and E-Cigarette Dependence

    Time frame: Assessed 4, 6, and 12 weeks follow-up

    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.

  4. Comparing E-Cigarettes and Cigarettes Questionnaire

    Time frame: Assessed 4, 6, and 12 weeks follow-up

    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.

  5. Weight

    Time frame: Assessed 4, 6, and 12 weeks follow-up

    Measured body weight in pounds

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and E-Cigarettes

Acronym: THRIVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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