Trial for Harm Reduction With Incentives & Vaping E-cigarettes

NCT06111053 | Completed

• 2 other identifiers: 2022003359P20GM130414
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Smoking Cessation

Keywords

obesity; overweight; electronic nicotine delivery systems; contingent incentives; harm reduction

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Daily for 4 weeks

Secondary Outcomes (5)

• Motivation to change

  Assessed 4, 6, and 12 weeks follow-up

• Carbon monoxide (CO)

  Assessed 4, 6, and 12 weeks follow-up

• Cigarette and E-Cigarette Dependence

  Assessed 4, 6, and 12 weeks follow-up

• Comparing E-Cigarettes and Cigarettes Questionnaire

  Assessed 4, 6, and 12 weeks follow-up

• Weight

  Assessed 4, 6, and 12 weeks follow-up

Study Arms (4)

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).

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).

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).

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).

Other: No ENDS; Other: NI

Interventions

ENDS OTHER

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

Also known as: Electronic Nicotine Delivery Systems

ENDS and CI; ENDS and NI

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.

Also known as: Contingent Incentives

ENDS and CI; No ENDS and CI

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.

No ENDS and CI; No ENDS and NI

NI OTHER

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

Also known as: Non-Contingent Incentives

ENDS and NI; No ENDS and NI

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 25 kg/m2
• smoked ≥ 5 cigarettes/day during the past year
• or older
• exhaled CO of \> 6 ppm at Baseline
• willing to use ENDs for 6 weeks
• daily access to a Bluetooth-enabled smartphone/tablet

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Obesity; Smoking Cessation; Overweight; Vaping; Harm Reduction

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Cara M Murphy, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know the outcome of randomized assignment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: November 1, 2023
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Clinical Laboratory Core data collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication with no prespecified end date.
• Access Criteria: After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.

Locations

US (1)