Tobacco Dependence Caused by CigarettesNCT05918887
Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in SUD Treatment
A study testing NJOY ACE commercial e-cigarette in people with Tobacco Dependence Caused by Cigarettes, run by University of Nevada, Reno at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Dependence Caused by Cigarettes
- What is being tested?
- NJOY ACE commercial e-cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 13 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment) or other local treatment center
- 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?"
- 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
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- self-reports daily smoking
- records an exhaled air carbon monoxide (CO) level >6ppm at baseline study visit
- has the capacity to understand the participant materials and follow the study procedures (e.g. sufficient English language ability).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in Substance Use Disorder Treatment
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.
Read the 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.
- Conditions
- Tobacco Dependence Caused by Cigarettes
- Being tested
- NJOY ACE commercial e-cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NJOY ACE commercial e-cigaretteDevice
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
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette arm | Experimental | Participants will receive the commercially available NJOY ACE e-cigarette, nicotine pods (2 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the ACE ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys. Receives: Device: NJOY ACE commercial e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average number of cigarettes consumed - Week 2 vs. Week 1
Change in average cigarette consumption per day as a function of daily e-cigarette use
Measured: Week 2 vs. Week 1
Change in average number of cigarettes consumed - Week 3 vs. Week 1
Change in average cigarette consumption per day as a function of daily e-cigarette use
Measured: Week 3 vs. Week 1
Secondary outcomes (5)
Recruitment feasibility
50% of people who are screened for the study who are eligible and consent to participate in the study at Study Visit 1
Measured: Week 1
Attrition feasibility
66.6% of consented participants will complete the study
Measured: Through study completion, up to Week 4
Adherence fidelity
80% of people who report using the e-cigarette at least once a day in Weeks 2 and 3
Measured: Weeks 2 and 3
EMA scheduled prompt feasibility
80% of people who complete at least 1 scheduled prompt a day
Measured: Weeks 1-3
EMA random prompt feasibility
80% of people who complete at least 1 random prompt a day
Measured: Weeks 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start18 Jun 2024
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Dependence Caused by CigarettesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Pearson, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918887
- Sponsor's protocol ID
- 2040809
- Status last verified
- May 2025
- First submitted
- 15 Jun 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in Substance Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT05918887
- Acronym / sponsor ID
- 2040809
- Conditions
- Tobacco Dependence Caused by Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-cigarette arm | Experimental | Device: NJOY ACE commercial e-cigaretteParticipants will receive the commercially available NJOY ACE e-cigarette, nicotine pods (2 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the ACE ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment) or other local treatment center
- 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?"
- has a cellphone with an unlimited text message plan
- has had the same phone number for at least 1 month
Key exclusion criteria (3 listed)
- have used an e-cigarette to quit smoking in the past month
- are currently pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NJOY ACE commercial e-cigaretteThe 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 | Device | E-cigarette arm |
Primary outcome
Change in average number of cigarettes consumed - Week 2 vs. Week 1
Time frame: Week 2 vs. Week 1
Change in average cigarette consumption per day as a function of daily e-cigarette use
Change in average number of cigarettes consumed - Week 3 vs. Week 1
Time frame: Week 3 vs. Week 1
Change in average cigarette consumption per day as a function of daily e-cigarette use
5 secondary outcomes
Recruitment feasibility
Time frame: Week 1
Attrition feasibility
Time frame: Through study completion, up to Week 4
Adherence fidelity
Time frame: Weeks 2 and 3
EMA scheduled prompt feasibility
Time frame: Weeks 1-3
EMA random prompt feasibility
Time frame: Weeks 1-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NJOY ACE commercial e-cigarette in people with Tobacco Dependence Caused by Cigarettes, run by University of Nevada, Reno at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average number of cigarettes consumed - Week 2 vs. Week 1 (time frame: Week 2 vs. Week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.