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

Cigarette Smoking Clinical Trial

— EXCHANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743532
• Other study ID #: 10124
• Status: Completed
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• E-cigarette Switching
Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.
• Financial Incentives
Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.

Locations

Country	Name	City	State
United States	Homeless Alliance	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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