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

NCT03743532 | Completed Results

• 1 other identifier: 10124
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Cigarette Smoking

Keywords

Smoking cessation; Contingency management; Financial incentives; E-cigarettes; Homelessness

Outcome Measures

Primary Outcomes (2)

• Combustible Cigarette Cessation

  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

  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 Outcomes (10)

• Combustible Cigarette Cessation (Complete Case Analysis)

  4 weeks post-switch

• Combustible Cigarette Cessation (Complete Case Analysis)

  8 weeks post-switch

• Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline

  4 weeks post-switch

• Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline

  8 week post-switch

• Days of Combustible Cigarette Smoking, Past 7 Days

  4 weeks post-switch

Study Arms (2)

E-Cigarette Switching (EC)

EXPERIMENTAL

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.

Behavioral: E-cigarette Switching

E-Cigarette Switching + Financial Incentives (EC+FI)

EXPERIMENTAL

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.

Behavioral: E-cigarette Switching; Behavioral: Financial Incentives

Interventions

E-cigarette Switching BEHAVIORAL

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

Also known as: EC

E-Cigarette Switching (EC); E-Cigarette Switching + Financial Incentives (EC+FI)

Financial Incentives BEHAVIORAL

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

Also known as: FI

E-Cigarette Switching + Financial Incentives (EC+FI)

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Homeless Alliance

Oklahoma City, Oklahoma, 73106, United States

Location

Related Publications (2)

• Boozary LK, Frank-Pearce SG, Alexander AC, Sifat MS, Kurien J, Waring JJC, Ehlke SJ, Businelle MS, Ahluwalia JS, Kendzor DE. Tobacco use characteristics, treatment preferences, and motivation to quit among adults accessing a day shelter in Oklahoma City. Drug Alcohol Depend Rep. 2022 Nov 5;5:100117. doi: 10.1016/j.dadr.2022.100117. eCollection 2022 Dec.

  PMID: 36844157 BACKGROUND

• Sifat MS, Alexander AC, Businelle MS, Frank-Pearce SG, Boozary LK, Wagener TL, Ahluwalia JS, Kendzor DE. E-Cigarette switching and financial incentives to promote combustible cigarette cessation among adults accessing shelter services: A pilot study. Drug Alcohol Depend Rep. 2024 Nov 6;13:100295. doi: 10.1016/j.dadr.2024.100295. eCollection 2024 Dec.

  PMID: 39764385 RESULT

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Results Point of Contact

• Title: Dr. Darla E. Kendzor
• Organization: The University of Oklahoma Health Sciences

Darla-Kendzor@ouhsc.edu

(405) 271-7848

Study Officials

• Darla E. Kendzor, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: September 14, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 21, 2025
• Results First Posted: June 7, 2024

Record last verified: 2025-02

Locations

US (1)