Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in Substance Use Disorder Treatment
Study Details
Study Description
Brief Summary
The purpose of the proposed study is to examine the feasibility of integrating a smoking harm reduction program featuring provision of e-cigarettes and tailored instructions to switch into an existing substance use disorder treatment program. This longitudinal study includes three weeks of micro-surveys delivered via text messages to evaluate the intervention's feasibility and acceptability, gather initial effectiveness data, and understand participants' lived experience of smoking and vaping while engaged in substance use disorder treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Up to 30 daily cigarette smokers who are engaged in a substance use disorder treatment program and are not interested in quitting nicotine use but are interested in reducing the harm from smoking will be enrolled in the study. As people gain access to substance use disorder treatment and the acute risk of death due to overdose diminishes, there is a significant need for data-driven, novel, and scalable smoking harm reduction approaches that meet people in recovery "where they are" and help them live longer, healthier lives by either significantly reducing their smoking frequency or switching completely to a much lower harm nicotine product.
Our overall aims are to:
Aim 1. Examine the feasibility (e.g., enrollment, attrition), acceptability (e.g., e-cigarette use rates, user experience), and effectiveness (e.g., % who reduced smoking by at least 50% in Week 3 vs. Week 1; % who switched completely at Week 3) of the intervention on cigarette smoking among people engaged in substance use disorder treatment. We anticipate that of the 30 people enrolled, 20 will complete the protocol. In Week 1, participants will report their usual smoking to establish baseline behavior. In Week 2, we will provide participants with an e-cigarette, nicotine liquid, and instructions to switch developed in Aim 1. In Week 3, we will replenish participants' nicotine liquid supply and continue data collection.
Aim 2. Describe participants' understanding of the meaning and utility of cigarettes and e-cigarettes in their lives. Up to 20 participants will take part in a semi-structured interview at the end of Week 3. Interviews will focus on their experience trying to switch while engaged in substance use disorder treatment and how their cognitions, expectancies, social relationships, and norms evolved over the 2 weeks of e-cigarette use. Qualitative data will add context and explanation to quantitative data collected in Aim 1 and will identify opportunities to improve the intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E-cigarette arm Participants will receive the NIDA Standardize Research E-Cigarette (SREC), nicotine pods (1 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the SREC ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys. |
Other: NIDA Standardized Research Electronic Cigarette
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices.
Nicotine pods:
Sealed, pre-filled, non-refillable
1.9 mL e-liquid with 5% w/w nicotine (placebo also available)
Approx 300 (280-330) puffs/pod
Nicotine liquid characteristics:
Volume of liquid per pod 1.9 mL
Active (nicotine USP 5% wt/wt) and placebo (nicotine 0%)
Propylene Glycol USP & Vegetable Glycerin USP - PG/VG Ratio 0.77
Lactic Acid USP
Battery characteristics:
USB Rechargeable
Storage Capacity ~ 400 mAh
Approx 200 (3s) puffs / charge
300 charge cycles to > 80% initial capacity
Time to full charge 75 - 85 min
Voltage / Temperature settings not user adjustable
|
Outcome Measures
Primary Outcome Measures
- Change in cigarette consumption - Week 2 vs. Week 1 [Week 2 vs. Week 1]
Change in average cigarette consumption per day as a function of daily e-cigarette use
- Change in cigarette consumption - Week 3 vs. Week 1 [Week 3 vs. Week 1]
Change in average cigarette consumption per day as a function of daily e-cigarette use
Other Outcome Measures
- Smoking reduction [Week 3 vs. Week 1]
Percent of participants who reduced their smoking by at least 50%
- Complete switching to e-cigarettes [Week 3]
Percent of participants who completely switched to e-cigarettes by the end of Week 3
- Attrition [Week 3 vs. Week 1]
Percent of people who consent to participate in the study but do not complete the protocol
Eligibility Criteria
Criteria
Inclusion Criteria:
-
currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment)
-
aged 21+
-
interested in switching from cigarettes to e-cigarettes, assessed by the item "Are you interested in replacing some or all of your cigarettes with e-cigarettes?"
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has a cellphone with an unlimited text message plan
-
has had the same phone number for at least 1 month
-
uses text messages at least once a week
-
self-reports daily smoking
-
records an exhaled air carbon monoxide (CO) level >6ppm at baseline study visit
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has the capacity to understand the participant materials and follow the study procedures (e.g. sufficient English language ability).
Exclusion Criteria:
Individuals who meet any the following criteria will not be enrolled in this study:
-
have used an e-cigarette to quit smoking in the past month
-
are currently pregnant or breast-feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nevada, Reno | Reno | Nevada | United States | 89557 |
Sponsors and Collaborators
- University of Nevada, Reno
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2040809