E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services (EXCHANGE)

February 7, 2025 updated by: University of Oklahoma

A Needs Survey of Urban Day Shelter Users and Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation: The Exchange Project

This randomized controlled trial evaluated the feasibility and potential efficacy of 1) e-cigarette switching (EC) or 2) e-cigarette switching + financial incentives for combustible cigarette cessation (EC+FI)

Study Overview

Detailed Description

The current study examined the feasibility of e-cigarette switching and financial incentives contingent on combustible cigarette abstinence to promote combustible cigarette cessation among urban day shelter guests (N=60). A total of 60 adults who accessed the Homeless Alliance day shelter in Oklahoma City, OK were randomly assigned to 1 of 2 groups and followed weekly from 1 week prior to a scheduled EC switch date through 4 weeks post-switch date, with a final 8-week post-switch follow-up. The intervention groups were: 1) e-cigarette switching (EC) or 2) EC switching + small financial incentives for carbon monoxide (CO) verified combustible cigarette abstinence (FI + EC). The primary outcomes were self-reported combustible cigarette abstinence over the previous 7 days with carbon monoxide (CO)-verification at 4- and 8- weeks follow-up. Secondary outcomes included changes in CO from baseline, days of combustible cigarette smoking, and continued e-cigarette use. Other feasibility outcomes included study retention and perceptions of the intervention.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Homeless Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

  1. ≥21 years of age
  2. Expired CO level ≥8 ppm suggestive of current smoking
  3. reported smoking ≥5 cigarettes per day
  4. Willing and able to attend 8 study visits over a 10-week period
  5. Interested in switching from CCs to ECs
  6. Willing to abstain from smoking cannabis for the duration of the study
  7. Able to speak and understand English
  8. Demonstrated >6th grade English literacy by earning a score ≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF),
  9. Able to read a 3-sentence selection from the consent form
  10. Not pregnant, breastfeeding, or planning to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-Cigarette Switching (EC)
Participants were provided with an e-cigarette device and nicotine pods and advised to completely switch from combustible cigarettes to e-cigarettes. Although participants in the EC group did not earn incentives for combustible cigarette abstinence, they were yoked with a participant in the EC+FI group (described below), and they earned the same weekly incentive amount as their counterpart earned for combustible cigarette abstinence credited to a reloadable study credit card.
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
Other Names:
  • EC
Experimental: E-Cigarette Switching + Financial Incentives (EC+FI)
Participants assigned to the EC+FI group received ECs and pods and were instructed to switch from combustible cigarettes to e-cigarettes as described above for the EC group. Participants also earned escalating financial incentives for self-reported and carbon-monoxide-verified combustible cigarette abstinence via credits to a reloadable study credit card. Participants who reported combustible cigarette use and/or had a CO level >6 ppm did not earn incentives that week, but could earn incentives at the next visit with the incentive value reset to the starting value.
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
Other Names:
  • EC
Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.
Other Names:
  • FI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combustible Cigarette Cessation
Time Frame: 4 weeks post-switch date
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
4 weeks post-switch date
Combustible Cigarette Cessation
Time Frame: 8 weeks post-quit/switch date
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
8 weeks post-quit/switch date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combustible Cigarette Cessation (Complete Case Analysis)
Time Frame: 4 weeks post-switch
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)
4 weeks post-switch
Combustible Cigarette Cessation (Complete Case Analysis)
Time Frame: 8 weeks post-switch
Self-reported and Carbon monoxide-verified (<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)
8 weeks post-switch
Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
Time Frame: 4 weeks post-switch
Change in expired CO (ppm) from baseline to 4 weeks post-switch-date.
4 weeks post-switch
Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
Time Frame: 8 week post-switch
Change in expired CO (ppm) from baseline to 8 weeks post-switch-date
8 week post-switch
Days of Combustible Cigarette Smoking, Past 7 Days
Time Frame: 4 weeks post-switch
The total number of days of combustible cigarette smoking during the past week
4 weeks post-switch
Days of Combustible Cigarette Smoking, Past 7 Days
Time Frame: 8 weeks post-switch
The total number of days of combustible cigarette smoking during the past 7 days
8 weeks post-switch
Days of E-cigarette Use, Past 7 Days
Time Frame: 4 weeks post-switch
The total number of days where e-cigarettes were used during the past 7 days
4 weeks post-switch
Days of E-cigarette Use, Past 7 Days
Time Frame: 8 weeks post-switch
The total number of days on which E-cigarettes were used during the past 7 days
8 weeks post-switch
Follow-Up Completion
Time Frame: 4 weeks post-switch
The number of participants who completed the smoking status follow-up assessment.
4 weeks post-switch
Follow-Up Completion
Time Frame: 8 weeks post-switch
The number of participants who completed the smoking status follow-up assessment
8 weeks post-switch

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Darla E. Kendzor, PhD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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