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Completed

NCT Number: NCT03743532

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

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)

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Homeless Alliance

Oklahoma City, Oklahoma, 73106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

E-cigarette Switching

Behavioral

Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.

Other names: EC

Financial Incentives

Behavioral

Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.

Other names: FI

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Follow-Up Completion

    Time frame: 4 weeks post-switch

    The number of participants who completed the smoking status follow-up assessment.

  10. Follow-Up Completion

    Time frame: 8 weeks post-switch

    The number of participants who completed the smoking status follow-up assessment

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: EXCHANGE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2018
Registry last updated
Feb 21, 2025

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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