Clinical trial NCT03743532: E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services
Official title: A Needs Survey of Urban Day Shelter Users and Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation: The Exchange Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Smoking cessation
Contingency management
Financial incentives
E-cigarettes
Homelessness
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Combustible Cigarette Cessation
timeFrame: 4 weeks post-switch date
measure: Combustible Cigarette Cessation
timeFrame: 8 weeks post-quit/switch date
Secondary outcomes:
measure: Combustible Cigarette Cessation (Complete Case Analysis)
timeFrame: 4 weeks post-switch
measure: Combustible Cigarette Cessation (Complete Case Analysis)
timeFrame: 8 weeks post-switch
measure: Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
timeFrame: 4 weeks post-switch
measure: Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline
timeFrame: 8 week post-switch
measure: Days of Combustible Cigarette Smoking, Past 7 Days
timeFrame: 4 weeks post-switch
measure: Days of Combustible Cigarette Smoking, Past 7 Days
timeFrame: 8 weeks post-switch
measure: Days of E-cigarette Use, Past 7 Days
timeFrame: 4 weeks post-switch
measure: Days of E-cigarette Use, Past 7 Days
timeFrame: 8 weeks post-switch
measure: Follow-Up Completion
timeFrame: 4 weeks post-switch
measure: Follow-Up Completion
timeFrame: 8 weeks post-switch
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Homeless Alliance
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Darla E. Kendzor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.