Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation (Exchange Project Sub-Study)

Study Overview
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Brief Summary
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This sub-study component (n = 60) of The Exchange Project will: characterize reductions in cigarette smoking following the provision of: 1) an e-cigarette device and supplies (device charger, pods), 2) e-cigarette + financial incentives for cigarette cessation, among homeless adults randomized to 1 of the 2 intervention arms.

Detailed Description
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Sub-study participants will be randomly assigned to: 1) the provision of an e-cigarette device and supplies/pods through 4 weeks post-switch along with directions to switch over from combustible cigarettes to e-cigarettes exclusively, or 2) the combination of an e-cigarette device and supplies through 4 weeks post-switch and financial rewards to incentivize combustible cigarette abstinence. In all groups, cigarette smoking will be monitored over a 8-week period to characterize reductions in cigarette smoking and rates of smoking cessation. It is anticipated that individuals who are provided with an e-cigarette device and supplies, and are also incentivized for completely switching from cigarette smoking to e-cigarette use will show the greatest reductions in cigarette smoking and be the most likely to stop smoking combustible cigarettes altogether. The long-term objective of the sub-study is to identify strategies to help homeless adults quit smoking or switch to e-cigarettes as a harm reduction strategy.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: E-cigarette
* Behavioral: Financial incentives + E-cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 6th grade English literacy level ≥ 18 years of age an expired carbon monoxide (CO) level ≥ 8 ppm (suggestive of current smoking) currently smoking ≥ 5 cigarettes per day willing and able to attend 6 weekly study visits over a 5 week period interest in switching from smoking cigarettes to using e-cigarettes motivation to quit smoking in the near future have not smoked marijuana in the past 30 days have not used e-cigarettes in the past 30 days not pregnant or breast feeding or planning to become pregnant Exclusion Criteria: < 6th grade English literacy level < 18 years of age an expired CO level < 8 ppm currently smoking < 5 cigarettes per day unwilling and unable to attend 6 weekly study visits over a 5 week period no interest in switching from smoking cigarettes to using e-cigarettes no motivation to quit smoking in the near future have smoked marijuana in the past 30 days have used e-cigarettes in the past 30 days pregnant or breast feeding or planning to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Ciagrette<br>Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. | Behavioral: E-cigarette<br>* Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.<br>|
| Experimental: Financial Incentives + E-cigarette<br>Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date. | Behavioral: Financial incentives + E-cigarette<br>* Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette Smoking Cessation | Self-reported cigarette smoking abstinence during the previous 7 days (at 4 weeks post-quit/switch), corroborated with an exhaled carbon monoxide level of < 6 ppm. | 5 weeks post-enrollment/4 weeks post-quit/switch date | 
| Switching to e-Cigarettes | Self-reported cigarette smoking abstinence during the previous 7 days (at 4 weeks post-quit/switch), corroborated with an exhaled carbon monoxide level of < 6 ppm. E-cigarette use reported during the past 7 days. | 5 weeks post-enrollment/4 weeks post-quit/switch date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of e-cigarette devices | The total number of e-cigarette devices lost by participants during the study. | 5 weeks post-enrollment/4 weeks post-quit/switch date | 
| Financial Incentives Earned | Average total amount earned by participants (out of $150) for biochemically-verified abstinence. | 5 weeks post-enrollment/4 weeks post-quit/switch date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Contingency management, Financial incentives, JUUL, VUSE