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NCT05881304 · ClinicalTrials.gov registry record · NA
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
A NA study of Electronic Cigarette Use, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05881304: Recruiting NA study of Electronic Cigarette Use, sponsored by Massachusetts General Hospital.
NCT05881304 is a NA study of Electronic Cigarette Use that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 210-participant average among 15 other Electronic Cigarette Use trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05881304, a NA study of Electronic Cigarette Use, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day \[primary outcome\], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control \[WLC\]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC).
Primary Outcome
Change in cigarettes smoked per day (CPD) between randomized groups. Change in mean number of CPD in the past 7 days from Baseline 2 to Week 8 comparing between randomized groups (iSREC group vs. WLC).
Conditions Studied
Interventions
- DEVICE Standardized research e-cigarette (SREC)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2026-06-01 |
| Phase | NA |
What NCT05881304 shows while recruiting
NCT05881304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 210-participant average among 15 other Electronic Cigarette Use trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Electronic Cigarette Use appearing as the primary indexed condition, and to 1 intervention - of which Standardized research e-cigarette (SREC) is the first listed.
NCT05881304 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05881304 about?
NCT05881304 is a clinical study titled "Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC". The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist con...
What is the current status of trial NCT05881304?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-06-03. Estimated completion is 2026-06-01.
What conditions does trial NCT05881304 study?
This clinical trial studies the following conditions: Electronic Cigarette Use.
What interventions are being tested in trial NCT05881304?
The interventions under investigation include: Standardized research e-cigarette (SREC) (DEVICE).
Who is sponsoring clinical trial NCT05881304?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05881304 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05881304's enrollment target sits among peer trials
40 11th of 15 higher than 5 of 15 other Electronic Cigarette Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Electronic Cigarette Use 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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