Vaping for Opioid Use Disorder

(SWITCHED Trial)

Overseen By Joanna M Streck, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Buprenorphine

Disqualifiers: Pregnant, Non-cigarette nicotine, Unstable psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific type of e-cigarette, the Standardized Research Electronic Cigarette (SREC), can help individuals not ready to quit smoking reduce their cigarette use. Participants will be divided into two groups: one will receive the e-cigarettes immediately, while the other will start after eight weeks. The study will examine how this switch impacts smoking habits, physical health, and smoking-related symptoms. The trial seeks participants who smoke at least 10 cigarettes daily, are on stable buprenorphine treatment for opioid use disorder, and are open to trying e-cigarettes without being ready to quit smoking. As an unphased trial, it offers a unique opportunity to explore new methods for reducing smoking without the pressure to quit entirely.

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 prior data suggests that the standardized research e-cigarette (SREC) is safe for tobacco use disorder?

Research shows that the Standardized Research E-Cigarette (SREC) is under study as a potentially safer alternative to traditional cigarettes, particularly for individuals with opioid use disorder. The goal is to reduce smoking-related harm. Early results suggest that many find vaping less harsh on the body compared to smoking regular cigarettes. However, researchers are still gathering specific safety information about the SREC.

The SREC is part of an early-stage study, so safety remains a primary focus, and detailed safety information may not yet be complete. Prospective trial participants should note that e-cigarettes generally contain fewer harmful chemicals than traditional cigarettes, which might imply fewer health risks. Staying informed about new research findings is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using standardized research e-cigarettes (SRECs) for opioid use disorder because they offer a novel approach compared to traditional treatments like medication-assisted therapy with methadone or buprenorphine. Unlike these medications, which directly address opioid cravings and withdrawal symptoms, SRECs may provide a non-pharmacological alternative by potentially reducing stress and anxiety associated with quitting opioids through the act of vaping. This method could be particularly appealing to those who are looking for a different kind of aid in managing their disorder, providing a behavioral substitute that could help ease the transition away from opioid use.

What evidence suggests that the standardized research e-cigarette (SREC) is effective for reducing tobacco use in individuals with opioid use disorder?

Research has shown that e-cigarettes might help smokers, including those with opioid use disorder, by reducing harm. Studies have found that e-cigarettes can help people smoke fewer regular cigarettes each day, which is especially beneficial for those not ready to quit smoking completely. Previous research found that smokers in opioid use disorder treatment were moderately open to using e-cigarettes, suggesting they could be a good alternative to regular cigarettes. In this trial, participants will receive the special research e-cigarette (SREC) to help reduce smoking-related harm, potentially offering short-term health benefits. However, more research is needed to understand its long-term effectiveness. ^{2 3 6 7 8}

Who Is on the Research Team?

Joanna M Streck, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

Not ready to quit smoking (not planning to quit in the next 30 days)

Willing to try e-cigarettes

I have smoked 10 or more cigarettes daily in the past week.

Exclusion Criteria

Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (>3 days in past 30 days)

Deemed inappropriate for participation by their OUD provider

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the standardized research e-cigarette (SREC) for 8 weeks

8 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final follow-up assessment

Waitlist Control

Participants in the waitlist control group receive SREC after an 8-week delay

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standardized research e-cigarette (SREC)

Trial Overview

The study tests if switching smokers with opioid use disorder to a standardized research e-cigarette (SREC) affects their smoking habits, dependence, withdrawal symptoms, health markers like carbon monoxide levels, and short-term health effects. Participants will be randomly assigned to start using SREC immediately or after an 8-week wait.

How Is the Trial Designed?

Group I: Immediate SREC provision (iSREC) Experimental Treatment 1 Intervention

Those randomized to the iSREC group will be provided a free 8-week supply of standardized research e-cigarettes (SRECs) and asked to try to switch completely to the SREC.

Group II: Delayed SREC provision waitlist control (WLC) Active Control 1 Intervention

Those in the WLC condition will receive SREC provision after an 8-week delay.

Standardized research e-cigarette (SREC) is already approved in United States for the following indications:

Approved in United States as SREC for:

• Investigational Tobacco Product (ITP) for research purposes only

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A study of 32 adolescents and young adults receiving medication treatment for opioid use disorder revealed a high prevalence of nicotine use, with 97% having tried combustible cigarettes and 90% having tried e-cigarettes, indicating early initiation of nicotine use.

Most participants (71%) reported daily use of combustible cigarettes, highlighting a significant concern for this population, and suggesting the need for targeted interventions like universal nicotine screening and tailored cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and perceptions of nicotine use among U.S. adolescents and young adults receiving medication treatment for opioid use disorder. Watson, ML., McKnight, ER., Groner, JA., et al.[2023]

A pilot study involving 25 daily smokers with opioid use disorders showed high interest in using electronic cigarettes (ECIGs), with a 93.9% enrollment rate and 70.9% retention over two weeks.

While participants reported reduced cigarette consumption, only 8% achieved biologically-confirmed smoking abstinence, indicating that while ECIGs may be appealing, their effectiveness in promoting long-term cessation needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot investigation of the effect of electronic cigarettes on smoking behavior among opioid-dependent smokers. Felicione, NJ., Enlow, P., Elswick, D., et al.[2020]

A significant majority of individuals receiving medication treatment for opioid use disorder (93%) view cigarettes as very harmful, while 63% also see e-cigarettes as harmful, indicating a strong awareness of health risks associated with both.

Despite concerns about health harms, 65% of participants found e-cigarettes helpful for reducing or quitting cigarette use, suggesting potential acceptability as a harm reduction strategy among those in buprenorphine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of E-cigarettes among adults in treatment for opioid use disorder. Streck, JM., Regan, S., Kalkhoran, S., et al.[2023]

Cognitive factors such as attitudes, expectancies, and social norms significantly predict the co-use of nicotine and cannabis among vapers aged 18 to 30, beyond demographic and psychological factors like anxiety and depression.

Positive expectancies about vaping are particularly influential in predicting polysubstance use, suggesting that interventions aimed at changing these expectancies could be effective in preventing polysubstance vaping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of polysubstance vaping in emerging adults. Bessenyei, K., Yakovenko, I.[2023]

A survey of e-cigarette users revealed that the average age of respondents was 27.4 years, with a majority identifying as male (73%), and that vape pens were the most commonly used devices for consuming various drugs other than nicotine.

Cannabinoids were the most frequently reported drug class used in e-cigs, highlighting a trend in poly-substance use and raising public safety concerns regarding contexts of use, such as driving and social events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of U.S. Residents and Their Usage of Electronic Cigarettes with Drugs Other Than Nicotine. Holt, AK., Rudy, AK., Sawyer, AN., et al.[2023]

Among 1127 individuals in substance abuse treatment, 59.8% reported lifetime e-cigarette use, with 23.6% using them in the past 30 days, highlighting a significant prevalence of e-cigarette use in this population.

Daily e-cigarette users were more likely to be former smokers and from methadone clinics, indicating that e-cigarette use may be associated with specific treatment settings and smoking history, which could inform treatment program policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Daily Versus Weekly Electronic Cigarette Users in Treatment for Substance Abuse. Gubner, NR., Pagano, A., Tajima, B., et al.[2019]

This systematic review aims to assess the impact of vaping on the physical and mental health of individuals with opioid use disorder (OUD), a population that often engages in polysubstance use, including vaping cannabis and nicotine.

The review will analyze data from various databases and will include quality assessments of the studies, providing a comprehensive understanding of how vaping may affect health outcomes in those with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between vaping and health outcomes in patients with opioid use disorder: a systematic review protocol. Sanger, N., D'Elia, A., Sanger, S., et al.[2021]

In a 6-week open trial with 12 methadone-maintained smokers, e-cigarettes led to significant reductions in cigarette consumption, with average decreases of 12.4 to 14.8 cigarettes per day at various follow-up points.

Despite only one participant achieving biochemically confirmed smoking cessation at week 7, adherence to e-cigarette use was high at 89.1%, suggesting that e-cigarettes may be a viable option for reducing tobacco use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open Trial of Electronic Cigarettes for Smoking Cessation Among Methadone-Maintained Smokers. Stein, MD., Caviness, C., Grimone, K., et al.[2018]

A study of 315 opioid dependent smokers revealed that 98.7% had heard of e-cigarettes, with 73.0% having tried them and 33.8% using them in the past month, indicating a high level of awareness and usage compared to the general population.

The primary motivations for using e-cigarettes included curiosity and the desire to quit nicotine, suggesting that e-cigs could be integrated into smoking cessation strategies for individuals with opioid dependence, although their optimal use as a cessation tool is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette knowledge, attitudes, and use in opioid dependent smokers. Stein, MD., Caviness, CM., Grimone, K., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05722561

E-Cigarettes for Harm Reduction in Smokers With Opioid ...

The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus ...

2.

nida.nih.gov

nida.nih.gov/about-nida/noras-blog/2025/09/toward-development-of-e-cigarettes-as-smoking-cessation-therapeutics

Toward the development of e-cigarettes as smoking- ...

Developing an FDA-approved e-cigarette for smoking cessation could improve public health.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9199932/

Interest in Electronic Cigarettes for Smoking Cessation ...

E-cigarettes had a moderate level of acceptability for smoking cessation among cigarette smokers in OUD treatment. More research is warranted to test the ...

4.

withpower.com

withpower.com/trial/phase-opioid-related-disorders-7-2023-b21dd

Vaping for Opioid Use Disorder (SWITCHED Trial)

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468266725001471

E-cigarettes in people with substance use disorder

This study found no difference between e-cigarette and cNRT groups in the primary outcome, self-reported 7-month continuous tobacco abstinence assessed 9 ...

6.

nida.nih.gov

nida.nih.gov/research/research-data-measures-resources/nida-drug-supply-program-dsp/nida-drug-supply-program-dsp-ordering-guidelines/nida-standardized-research-electronic-cigarette-srec-for-clinical-research

Ordering Guidelines for Standardized Research Electronic ...

The SREC was developed as a collaboration between NJOY LLC and NIDA. The goal of the Project is to facilitate clinical research into the impact of e-cigarettes ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772724622000014

Perceptions of E-cigarettes among adults in treatment for ...

We sought to determine the potential acceptability of e-cigarettes for cigarette harm reduction among individuals receiving medication treatment for opioid use ...

8.

sciences.altria.com

sciences.altria.com/en/library/nida-standardized-research-electronic-cigarette-for-clinical-research

NIDA Standardized Research Electronic Cigarette for Clinical ...

The primary objective of this project is to facilitate clinical research on the impact of e-cigarettes on public health.