Tobacco UseNCT06534905
E-cigarette Switching Older Adults
A study testing E-cigarette in people with Tobacco Use and Opioid Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Opioid Use Disorder, Tobacco-Related Disorders
- What is being tested?
- E-cigarette
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 31 Oct 2025
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years or older; currently in treatment for opioid use disorder for at least 3 months
- currently use tobacco (\>100 cigarettes in lifetime and smoke every day or some days)
- xpired air CO \>8ppm
- does not regularly use e-cigarettes (regular use defined as use in the past month for 2 or more consecutive days)
- not pregnant or breastfeeding
Who cannot join
- individuals trying to stop smoking or have a plan to quit smoking
- people age 49 or younger
- people who do not currently smoke tobacco
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Addiction Treatment Center (UMATC)
Baltimore, Maryland, 21223
About this study
Official title: Pilot Randomized Controlled Trial of E-cigarette Switching Among Older Adults With Opioid Use Disorder
The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial. The main questions the study aims to answer are:
- Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don\'t have a plan to quit?
- Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation (control)?
- Does the accuracy of nicotine/tobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education?
Read more
Participants will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8, each lasting 30-90 minutes, for a total of approximately 3-4 hours of participation in the study. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning.
Patients will be randomly assigned at baseline (if meeting eligibility criteria) to receive an e-cigarette product (name of product: NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).
Read the detailed description
Volunteers will be patients diagnosed with opioid use disorder (OUD) who have been in medication-based treatment (methadone or buprenorphine) at the University of Maryland Addiction Treatment Center (UMATC) at 1001 W Pratt Street for at least 3 months. The 3-month requirement will help to ensure that patients who enroll in this study have been stabilized on methadone and buprenorphine, which are first-line, evidence-based treatments for OUD.
All procedures associated with this study will be conducted at the UMATC. After completion of brief pre-screen questions to determine eligibility (i.e., age, tobacco use status, and plans to quit smoking), patients will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8 lasting between 30-90 minutes each with a total time of participation in the study of approximately 3-4 hours. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning. In addition, patients will be asked to provide a sample of their breath by breathing into a handheld device that measures air breath carbon monoxide levels.
At baseline, participants will be randomly assigned using a number generator to one of two conditions during the baseline session.
- standard, brief advice for motivating patients to quit (including linkage to a smoking cessation phone quitline) or 2) education on tobacco harms and provisions of NJOY Ace e-cigarette (menthol or tobacco flavor depending on patient preference). NJOY Ace e-cigarettes are a consumer product that has been authorized by the United States Food and Drug Administration. Participants will also be given disposable pods prefilled with nicotine. When the pod is empty, the participant will throw it away and replace it with a new pod provided by the study staff. Participants will be asked to use as little or as much of the e-cigarette during their study participation, including choosing not to use the product.
- Conditions
- Tobacco Use, Opioid Use Disorder, Tobacco-Related Disorders
- Being tested
- E-cigarette, Control/Standard Advice
- Keywords
- e-cigarette
- Medical subject headings
- Tobacco Use, Opioid-Related Disorders, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigaretteOther
Also called ENDS, vaporized nicotine
Each participant assigned to the e-cigarette group will given a rechargeable NJOY Ace e-cigarette that is either tobacco or mint-flavored (based on their preference). Participants will also be given disposable pods prefilled with nicotine. When the pod is empty, the participant will throw it away and replace it with a new pod provided by the study staff. Participants will be asked to use as little or as much of the e-cigarette during their study participation, including choosing not to use the product. Participants will also be given information on the relative harms of nicotine and tobacco products as recommended by the American Society of Addiction Medicine.
Control/Standard AdviceBehavioural
Brief advice to quit according recommendations from the American Society of Addiction Medicine
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette switching | Active comparator | NJOY Ace e-cigarette (menthol or tobacco flavor, depending on patient preference) to be used ad libitum. Receives: Other: E-cigarette |
| Standard brief advice to address tobacco use | Other | Usual Care/Treatment As Usual Patients will be exposed to a brief smoking cessation intervention (BI) based on long-standing tobacco treatment guidelines (Fiore, 2008) and recommendations in the newly revised 4th edition of the ASAM. If a patient reports wanting to stop smoking, they will be instructed to reach out to their medical provider at the treatment clinic. They will be given multiple state and federal resources for quitting smoking.
If the patient does not want to quit smoking during the brief intervention, we will check with them during the next session about their interest.
The brief smoking intervention will be delivered at each session to check on individuals who are attempting to quit and to possibly motivate those who aren't quitting to initiate a quit attempt. Receives: Behavioral: Control/Standard Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to quit smoking in next month
Measured by self-report in response to following question "Do you intend to stop smoking in the next month?"
Measured: up to 8 weeks
Change in cigarettes smoked per day (percent change)
Measured by self-report during study sessions
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start25 Nov 2024
- Primary completion9 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention is an e-cigarette (not an FDA approved treatment)
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethea A Kleykamp, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534905
- Sponsor's protocol ID
- HP-00110720
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of E-cigarette Switching Among Older Adults With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06534905
- Acronym / sponsor ID
- HP-00110720
- Conditions
- Tobacco Use, Opioid Use Disorder, Tobacco-Related Disorders
- Keywords
- e-cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 2 Aug 2024 (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 goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial. The main questions the study aims to answer are:
- Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don\'t have a plan to quit?
- Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation (control)?
- Does the accuracy of nicotine/tobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education?
Participants will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8, each lasting 30-90 minutes, for a total of approximately 3-4 hours of participation in the study. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning.
Patients will be randomly assigned at baseline (if meeting eligibility criteria) to receive an e-cigarette product (name of product: NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).
Detailed description
Volunteers will be patients diagnosed with opioid use disorder (OUD) who have been in medication-based treatment (methadone or buprenorphine) at the University of Maryland Addiction Treatment Center (UMATC) at 1001 W Pratt Street for at least 3 months. The 3-month requirement will help to ensure that patients who enroll in this study have been stabilized on methadone and buprenorphine, which are first-line, evidence-based treatments for OUD.
All procedures associated with this study will be conducted at the UMATC. After completion of brief pre-screen questions to determine eligibility (i.e., age, tobacco use status, and plans to quit smoking), patients will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8 lasting between 30-90 minutes each with a total time of participation in the study of approximately 3-4 hours. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning. In addition, patients will be asked to provide a sample of their breath by breathing into a handheld device that measures air breath carbon monoxide levels.
At baseline, participants will be randomly assigned using a number generator to one of two conditions during the baseline session.
- standard, brief advice for motivating patients to quit (including linkage to a smoking cessation phone quitline) or 2) education on tobacco harms and provisions of NJOY Ace e-cigarette (menthol or tobacco flavor depending on patient preference). NJOY Ace e-cigarettes are a consumer product that has been authorized by the United States Food and Drug Administration. Participants will also be given disposable pods prefilled with nicotine. When the pod is empty, the participant will throw it away and replace it with a new pod provided by the study staff. Participants will be asked to use as little or as much of the e-cigarette during their study participation, including choosing not to use the product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention is an e-cigarette (not an FDA approved treatment)
| Arm | Type | Receives |
|---|---|---|
| E-cigarette switching | Active comparator | Other: E-cigaretteNJOY Ace e-cigarette (menthol or tobacco flavor, depending on patient preference) to be used ad libitum. |
| Standard brief advice to address tobacco use | Other | Behavioral: Control/Standard AdviceUsual Care/Treatment As Usual Patients will be exposed to a brief smoking cessation intervention (BI) based on long-standing tobacco treatment guidelines (Fiore, 2008) and recommendations in the newly revised 4th edition of the ASAM. If a patient reports wanting to stop smoking, they will be instructed to reach out to their medical provider at the treatment clinic. They will be given multiple state and federal resources for quitting smoking. If the patient does not want to quit smoking during the brief intervention, we will check with them during the next session about their interest. The brief smoking intervention will be delivered at each session to check on individuals who are attempting to quit and to possibly motivate those who aren't quitting to initiate a quit attempt. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years or older; currently in treatment for opioid use disorder for at least 3 months
- currently use tobacco (\>100 cigarettes in lifetime and smoke every day or some days)
- xpired air CO \>8ppm
- does not regularly use e-cigarettes (regular use defined as use in the past month for 2 or more consecutive days)
- not pregnant or breastfeeding
Key exclusion criteria (3 listed)
- individuals trying to stop smoking or have a plan to quit smoking
- people age 49 or younger
- people who do not currently smoke tobacco
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 |
|---|---|---|
| E-cigaretteAlso: ENDS, vaporized nicotineEach participant assigned to the e-cigarette group will given a rechargeable NJOY Ace e-cigarette that is either tobacco or mint-flavored (based on their preference). Participants will also be given disposable pods prefilled with nicotine. When the pod is empty, the participant will throw it away and replace it with a new pod provided by the study staff. Participants will be asked to use as little or as much of the e-cigarette during their study participation, including choosing not to use the product. Participants will also be given information on the relative harms of nicotine and tobacco products as recommended by the American Society of Addiction Medicine. | Other | E-cigarette switching |
| Control/Standard AdviceBrief advice to quit according recommendations from the American Society of Addiction Medicine | Behavioural | Standard brief advice to address tobacco use |
Primary outcome
Intention to quit smoking in next month
Time frame: up to 8 weeks
Measured by self-report in response to following question "Do you intend to stop smoking in the next month?"
Change in cigarettes smoked per day (percent change)
Time frame: up to 8 weeks
Measured by self-report during study sessions
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 10 Jul 2026.
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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 E-cigarette in people with Tobacco Use and Opioid Use Disorder, run by University of Maryland, Baltimore 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 5 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 10 Jul 2026. 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?
Intention to quit smoking in next month (time frame: up to 8 weeks). 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 10 Jul 2026.