Nicotine DependencePhase 4SHINENCT05206435
Methadone-Maintained Smokers Switching to E-Cigarettes
A Phase 4 study testing Electronic Cigarette and Nicotine Lozenge in people with Nicotine Dependence and Electronic Cigarette Use, run by Butler Hospital at 1 site in United States.
Trial summary
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Nicotine Dependence, Electronic Cigarette Use
- What is being tested?
- Electronic Cigarette and Nicotine Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to heavy cigarette smokers (10 cigarettes/day for > 1 yr; breath CO > 10 ppm)
- have been receiving methadone for at least three months
- attend at least weekly to receive methadone dose
- speak English
- have a telephone or access to a telephone
- are available over the next 6 weeks
- are interested in switching to either electronic cigarettes or nicotine replacement therapy
Who cannot join
- use of ECs on > 2 of the past 30 days
- currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)
- have unstable psychiatric conditions
- have near-daily or daily use of marijuana
- are pregnant
- had a cardiovascular event in the last month
- daily medication for asthma or COPD
Trial locations and contacts
1 site in 1 country.
About this study
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
Read the detailed description
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT.
This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.
- Conditions
- Nicotine Dependence, Electronic Cigarette Use
- Being tested
- Electronic Cigarette, Nicotine Lozenge
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic CigaretteDrug
Electronic Cigarettes are provided to replace tobacco cigarettes
Nicotine LozengeDrug
Nicotine Lozenges are provided to replace tobacco cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Electronic Cigarettes | Active comparator | Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period. Receives: Drug: Electronic Cigarette |
| Nicotine Lozenges | Active comparator | Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period. Receives: Drug: Nicotine Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
NNAL
urinary measure of NNAL
Measured: 6 weeks
NNN
Urinary measure of NNN
Measured: 6 weeks
3-HPMA
Urinary measure of 3-HPMA
Measured: 6 weeks
Secondary outcomes (1)
Cigarettes Per Day
Mean number of cigarettes per day assessed via the Timeline Followback over the last 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start31 Mar 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206435
- Sponsor's protocol ID
- 1702236
- Other IDs
- R01DA052907
- Acronym
- SHINE
- Status last verified
- May 2026
- First submitted
- 21 Dec 2021
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone-Maintained Smokers Switching to E-Cigarettes
- ClinicalTrials.gov ID
- NCT05206435
- Acronym / sponsor ID
- SHINE / 1702236
- Conditions
- Nicotine Dependence, Electronic Cigarette Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
Detailed description
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT.
This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Cigarettes | Active comparator | Drug: Electronic CigaretteParticipants in this arm are randomized to receive electronic cigarettes for the 6-week study period. |
| Nicotine Lozenges | Active comparator | Drug: Nicotine LozengeParticipants in this arm are randomized to receive nicotine lozenge for the 6-week study period. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- moderate to heavy cigarette smokers (10 cigarettes/day for > 1 yr; breath CO > 10 ppm)
- have been receiving methadone for at least three months
- attend at least weekly to receive methadone dose
- speak English
- have a telephone or access to a telephone
Key exclusion criteria (7 listed)
- use of ECs on > 2 of the past 30 days
- currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)
- have unstable psychiatric conditions
- have near-daily or daily use of marijuana
- are pregnant
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 |
|---|---|---|
| Electronic CigaretteElectronic Cigarettes are provided to replace tobacco cigarettes | Drug | Electronic Cigarettes |
| Nicotine LozengeNicotine Lozenges are provided to replace tobacco cigarettes | Drug | Nicotine Lozenges |
Primary outcome
NNAL
Time frame: 6 weeks
urinary measure of NNAL
NNN
Time frame: 6 weeks
Urinary measure of NNN
3-HPMA
Time frame: 6 weeks
Urinary measure of 3-HPMA
1 secondary outcome
Cigarettes Per Day
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Nicotine Dependence
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Recruiting
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Smoking Cessation, Depression
Not yet recruitingPhase 2
Effects of Psilocybin on Craving in Nicotine Dependence
Nicotine Dependence
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 Phase 4 study testing Electronic Cigarette and Nicotine Lozenge in people with Nicotine Dependence and Electronic Cigarette Use, run by Butler Hospital 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 7 inclusion and 7 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 20 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
NNAL (time frame: 6 weeks). The study lists 3 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 20 Aug 2026.