Trial for Harm Reduction With Incentives & Vaping E-cigarettes
NCT ID: NCT06111053
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2023-11-01
2024-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
* 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
TREATMENT
SINGLE
Study Groups
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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).
ENDS
Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.
CI
Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.
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).
CI
Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.
No ENDS
Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.
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).
ENDS
Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.
NI
Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.
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).
No ENDS
Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.
NI
Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.
Interventions
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ENDS
Participants in active comparator groups that include ENDS will receive 6-weeks worth of ENDS supplies.
CI
Participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample.
No ENDS
Participants in active comparator groups labeled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes.
NI
Participants in active comparator groups labeled NI will receive compensation for each breath sample provided throughout the study, with no variation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
99 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Brown University
OTHER
Responsible Party
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Principal Investigators
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Cara M Murphy, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
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Brown University School of Public Health
Providence, Rhode Island, United States
Countries
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Other Identifiers
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2022003359
Identifier Type: -
Identifier Source: org_study_id
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