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NCT05206435 · ClinicalTrials.gov registry record · Phase 4
Methadone-Maintained Smokers Switching to E-Cigarettes
A Phase 4 study of Nicotine Dependence and Electronic Cigarette Use, sponsored by Butler Hospital.
- Active
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05206435: Active Phase 4 study of Nicotine Dependence and Electronic Cigarette Use, sponsored by Butler Hospital.
NCT05206435 is a Phase 4 study of Nicotine Dependence and Electronic Cigarette Use that is active but no longer recruiting, run by Butler Hospital. The registered enrollment target is 240 participants, above the 183-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (31% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206435, a Phase 4 study of Nicotine Dependence and Electronic Cigarette Use, is active but no longer recruiting, sponsored by Butler Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
urinary measure of NNAL
Conditions Studied
Interventions
- DRUG Nicotine Lozenge
- DRUG Electronic Cigarette
Study Locations (1)
Rhode Island
- Butler Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 4 |
What the registry record for NCT05206435 still lists
NCT05206435 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 183-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (31% higher).
The record links to 2 conditions, with Nicotine Dependence appearing as the primary indexed condition, and to 2 interventions - of which Nicotine Lozenge is the first listed.
NCT05206435 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05206435 about?
NCT05206435 is a clinical study titled "Methadone-Maintained Smokers Switching to E-Cigarettes". 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 ...
What is the current status of trial NCT05206435?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2022-03-31. Estimated completion is 2025-06-30.
What conditions does trial NCT05206435 study?
This clinical trial studies the following conditions: Nicotine Dependence, Electronic Cigarette Use.
What interventions are being tested in trial NCT05206435?
The interventions under investigation include: Nicotine Lozenge (DRUG), Electronic Cigarette (DRUG).
Who is sponsoring clinical trial NCT05206435?
This trial is sponsored by Butler Hospital, which has 103 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05206435 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05206435's enrollment target sits among peer trials
240 16th of 67 higher than 52 of 67 other Nicotine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nicotine Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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