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Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in SUD Treatment

Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in Substance Use Disorder Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05918887
Enrollment
31
Registered
2023-06-26
Start date
2024-06-18
Completion date
2024-09-13
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence Caused by Cigarettes

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.

Detailed description

The purpose of this 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. The proposed longitudinal study will include three weeks of micro-surveys delivered via text messages (called ecological momentary assessments, or EMA) 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. 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. 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. Aims include: 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. It is anticipated 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, participants will be provided with an e-cigarette, nicotine liquid, and instructions to switch developed in Aim 1. In Week 3, participants' nicotine liquid supply will be replenished, and data collection will continue. 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 complement quantitative data, adding participants' understanding of the why driving their behavior to the what captured with EMA, and will identify opportunities to improve the intervention and identify blind spots in our assessments for the main study. In-depth interviews also facilitate investigation of exploratory hypotheses that arise during data collection, suggesting additional areas of inquiry for a subsequent R01 proposal.

Interventions

DEVICENJOY ACE commercial e-cigarette

The NJOY ACE is the commercial version of the Standardized Research E-Cigarette (SREC), which was developed by NIDA with NJOY for research purposes. Nicotine pods: * Sealed, pre-filled, non-refillable * 1.9 mL e-liquid with 5% w/w nicotine * Approx 300 (280-330) puffs/pod Nicotine liquid characteristics: * Volume of liquid per pod 1.9 mL * Active (nicotine USP 5% wt/wt) * 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

Sponsors

University of Nevada, Reno
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment) or other local treatment center 2. aged 21+ 3. 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? 4. has a cellphone with an unlimited text message plan 5. has had the same phone number for at least 1 month 6. uses text messages at least once a week 7. self-reports daily smoking 8. records an exhaled air carbon monoxide (CO) level \>6ppm at baseline study visit 9. 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: 1. have used an e-cigarette to quit smoking in the past month 2. are currently pregnant or breast-feeding.

Design outcomes

Primary

MeasureTime frameDescription
Change in average number of cigarettes consumed - Week 3 vs. Week 1Week 3 vs. Week 1Change in average cigarette consumption per day as a function of daily e-cigarette use
Change in average number of cigarettes consumed - Week 2 vs. Week 1Week 2 vs. Week 1Change in average cigarette consumption per day as a function of daily e-cigarette use

Secondary

MeasureTime frameDescription
Attrition feasibilityThrough study completion, up to Week 466.6% of consented participants will complete the study
EMA scheduled prompt feasibilityWeeks 1-380% of people who complete at least 1 scheduled prompt a day
EMA random prompt feasibilityWeeks 1-380% of people who complete at least 1 random prompt a day
Adherence fidelityWeeks 2 and 380% of people who report using the e-cigarette at least once a day in Weeks 2 and 3
Recruitment feasibilityWeek 150% of people who are screened for the study who are eligible and consent to participate in the study at Study Visit 1

Other

MeasureTime frameDescription
Smoking reductionWeek 3 vs. Week 1Percent of participants who reduced their smoking by at least 50%
Complete switching to e-cigarettesWeek 3Percent of participants who completely switched to e-cigarettes by the end of Week 3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026