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

NCT ID: NCT03743532

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2023-03-01

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)

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.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

E-cigarette Switching

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

E-cigarette Switching

Intervention Type: BEHAVIORAL

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

Financial Incentives

Intervention Type: BEHAVIORAL

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

Interventions

E-cigarette Switching

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

Intervention Type: BEHAVIORAL

Financial Incentives

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

Intervention Type: BEHAVIORAL

Other Intervention Names

EC; FI

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darla E. Kendzor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Homeless Alliance

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36844157 (View on PubMed)

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.

Reference Type: RESULT

PMID: 39764385 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10124

Identifier Type: -

Identifier Source: org_study_id