ObesityTHRIVENCT06111053
Trial for Harm Reduction With Incentives & Vaping E-cigarettes
A study testing ENDS, CI and No ENDS in people with Obesity and Smoking Cessation, run by Brown University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Smoking Cessation
- What is being tested?
- ENDS, CI and No ENDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and 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.
Read the 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.
- Conditions
- Obesity, Smoking Cessation
- Being tested
- ENDS, CI, No ENDS, NI
- Keywords
- obesity, overweight, electronic nicotine delivery systems, contingent incentives, harm reduction
- Medical subject headings
- Obesity, Smoking Cessation, Overweight, Vaping, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDSOther
Also called Electronic Nicotine Delivery Systems
Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.
CIOther
Also called Contingent Incentives
Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.
No ENDSOther
Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.
NIOther
Also called Non-Contingent Incentives
Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.
| Study group | Role | What they receive |
|---|---|---|
| ENDS and CI | Experimental | 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). Receives: Other: ENDS; Other: CI |
| No ENDS and CI | Experimental | 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). Receives: Other: CI; Other: No ENDS |
| ENDS and NI | Experimental | 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). Receives: Other: ENDS; Other: NI |
| No ENDS and NI | Experimental | 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). Receives: Other: No ENDS; Other: NI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed 4, 6, and 12 weeks follow-up
Within-Treatment Smoking Abstinence
Number of days during the incentive period with CO verified abstinence from smoking
Measured: Daily for 4 weeks
Secondary outcomes (5)
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
Measured: Assessed 4, 6, and 12 weeks follow-up
Carbon monoxide (CO)
Exhaled breath sample used to measure carbon monoxide
Measured: Assessed 4, 6, and 12 weeks follow-up
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.
Measured: Assessed 4, 6, and 12 weeks follow-up
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.
Measured: Assessed 4, 6, and 12 weeks follow-up
Weight
Measured body weight in pounds
Measured: Assessed 4, 6, and 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Nov 2023
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Cara M Murphy, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111053
- Sponsor's protocol ID
- 2022003359
- Other IDs
- P20GM130414
- Acronym
- THRIVE
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be kept and used for future research on chronic disease and substance use.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and E-Cigarettes
- ClinicalTrials.gov ID
- NCT06111053
- Acronym / sponsor ID
- THRIVE / 2022003359
- Conditions
- Obesity, Smoking Cessation
- Keywords
- obesity, overweight, electronic nicotine delivery systems, contingent incentives, harm reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| ENDS and CI | Experimental | Other: ENDS, Other: CIParticipants 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). |
| No ENDS and CI | Experimental | Other: CI, Other: No ENDSParticipants 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). |
| ENDS and NI | Experimental | Other: ENDS, Other: NIParticipants 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). |
| No ENDS and NI | Experimental | Other: No ENDS, Other: NIParticipants 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). |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDSAlso: Electronic Nicotine Delivery SystemsParticipants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies. | Other | ENDS and CI, ENDS and NI |
| CIAlso: Contingent IncentivesParticipants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample. | Other | ENDS and CI, No ENDS and CI |
| No ENDSParticipants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes. | Other | No ENDS and CI, No ENDS and NI |
| NIAlso: Non-Contingent IncentivesParticipants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation. | Other | ENDS and NI, No ENDS and NI |
Primary outcome
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.
Within-Treatment Smoking Abstinence
Time frame: Daily for 4 weeks
Number of days during the incentive period with CO verified abstinence from smoking
5 secondary outcomes
Motivation to change
Time frame: Assessed 4, 6, and 12 weeks follow-up
Carbon monoxide (CO)
Time frame: Assessed 4, 6, and 12 weeks follow-up
Cigarette and E-Cigarette Dependence
Time frame: Assessed 4, 6, and 12 weeks follow-up
Comparing E-Cigarettes and Cigarettes Questionnaire
Time frame: Assessed 4, 6, and 12 weeks follow-up
Weight
Time frame: Assessed 4, 6, and 12 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. Deidentified data will be kept and used for future research on chronic disease and substance use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara M Murphy, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDS, CI and No ENDS in people with Obesity and Smoking Cessation, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Cigarettes and ENDS (time frame: Assessed 4, 6, and 12 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.