Vaping for Opioid Use Disorder
(SWITCHED Trial)
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be stable on your current buprenorphine treatment for opioid use disorder.
What data supports the effectiveness of the treatment Standardized research e-cigarette (SREC) for opioid use disorder?
Research suggests that electronic cigarettes (e-cigarettes) may be a viable harm reduction strategy for individuals with opioid use disorder (OUD) who smoke, as traditional smoking cessation methods have low success rates in this group. Studies indicate that e-cigarettes are considered acceptable and potentially helpful for reducing cigarette harm among those receiving medication treatment for OUD.12345
Is vaping generally safe for humans, especially in the context of opioid use disorder?
The studies reviewed do not provide specific safety data on vaping for opioid use disorder, but they suggest that e-cigarettes are considered a harm reduction tool for smokers with opioid dependence. However, the safety of e-cigarettes in general remains a topic of debate, and their use should be discussed with healthcare providers.12367
How is the treatment using the Standardized Research E-Cigarette (SREC) different from other treatments for opioid use disorder?
The Standardized Research E-Cigarette (SREC) is unique because it uses vaping as a harm reduction strategy to help individuals with opioid use disorder reduce smoking, which is often difficult to achieve with traditional methods. Unlike standard treatments that focus solely on opioids, this approach targets the high smoking rates in this population, offering a novel way to address both nicotine and opioid use.12389
Research Team
Joanna M Streck, PhD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for adults over 18 who smoke at least 10 cigarettes daily, are not planning to quit in the next month but willing to try e-cigarettes, and have been stable on buprenorphine treatment for opioid use disorder at an MGH-affiliated clinic for at least 3 months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the standardized research e-cigarette (SREC) for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Waitlist Control
Participants in the waitlist control group receive SREC after an 8-week delay
Treatment Details
Interventions
- Standardized research e-cigarette (SREC)
Standardized research e-cigarette (SREC) is already approved in United States for the following indications:
- Investigational Tobacco Product (ITP) for research purposes only
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator