E-Cigarettes + NRT and Counseling for Smoking in Opioid Use Disorder

Recruiting at 2 trial locations

Overseen By Mohsen Abbasi, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must be taking: Methadone, Buprenorphine

Disqualifiers: Pregnancy, COPD, Asthma, Depression, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

302 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals with opioid use disorder (OUD) reduce smoking. It compares the effectiveness of electronic cigarettes (e-cigs) and nicotine replacement therapy (NRT) combined with counseling. Participants will either use e-cigs or receive NRT along with telehealth counseling to determine which method is most effective in reducing cigarette smoking. The trial seeks individuals who have been in opioid treatment for at least 12 weeks, smoke five or more cigarettes a day, and are interested in reducing their smoking. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does require that participants have a stable dose of methadone or buprenorphine for at least two weeks before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nicotine replacement therapy (NRT), such as patches and lozenges, is generally safe for long-term use. Studies have found that NRT does not increase the risk of heart attacks or strokes, even for those who continue smoking. However, while NRT is safe, it might not be as effective on its own for individuals with opioid use disorder (OUD).

For e-cigarettes, research is ongoing. Some studies suggest they can aid smoking cessation, but concerns remain. E-cigarettes can maintain nicotine dependence, which may pose a problem for those with OUD.

Both treatments have been studied for safety, but each presents its own challenges. NRT is usually well-tolerated and has a strong safety record. E-cigarettes might assist some in quitting smoking, but their safety and effectiveness, particularly for individuals with OUD, are still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new methods to help people with opioid use disorder quit smoking. Unlike traditional nicotine replacement therapies (NRT) that rely solely on products like patches and lozenges, one treatment arm investigates the use of a standardized research e-cigarette (SREC) combined with telehealth motivational counseling. This approach leverages the appeal and potential harm reduction of e-cigarettes, offering a novel delivery method for nicotine. By integrating motivational counseling with these distinct nicotine delivery systems, the trial aims to enhance quitting success rates, potentially providing more flexible options for managing nicotine cravings in this population.

What evidence suggests that this trial's treatments could be effective for reducing smoking in opioid use disorder?

This trial will compare the effectiveness of e-cigarettes and nicotine replacement therapy (NRT) for smoking cessation in individuals with opioid use disorder. Research has shown that e-cigarettes, which participants in the Electronic Cigarette arm of this trial will receive, can aid those struggling to quit smoking by delivering nicotine without the harmful smoke from burning tobacco. Early studies suggested that e-cigarettes might also assist smokers with opioid use disorder, who often find quitting difficult.

Participants in the Nicotine Replacement Therapy arm will receive NRT, such as patches and lozenges, which has been proven to help people stop smoking. Research has found that using both a patch and a fast-acting option like gum or lozenges can increase the chances of quitting. This combination has been effective even for those who find quitting especially challenging. ^{1 2 3 6 7}

Who Is on the Research Team?

Omar El-Shahawy

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 21 with opioid use disorder who are in treatment programs, smoke at least 5 cigarettes per day, and want to reduce smoking but not necessarily quit. They must have a stable dose of methadone or buprenorphine and access to a mobile phone. It's not for those trying to quit smoking, with severe mental health issues, respiratory diseases, pregnant/breastfeeding women, or users of other tobacco products.

Inclusion Criteria

Currently smokes 5 or more CPD

Has a diagnosis of Opioid Use Disorder

My methadone or buprenorphine dose has been stable for two weeks.

Exclusion Criteria

I am currently experiencing severe depression, thoughts of suicide, or have been hospitalized for psychiatric reasons in the past year.

Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)

Are 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 either electronic cigarettes with telehealth motivational counseling or combination nicotine replacement therapy with telehealth counseling

8 weeks

5 visits (telehealth)

Follow-up

Participants are monitored for smoking reduction and health-related quality of life improvements

6 months

What Are the Treatments Tested in This Trial?

Interventions

• National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC)
• Nicotine Replacement Product
• Telehealth Motivational Counseling

Trial Overview

The study tests if e-cigarettes combined with motivational counseling via telehealth can help reduce cigarette smoking more effectively than nicotine replacement therapy plus counseling in people undergoing opioid addiction treatment.

How Is the Trial Designed?

Group I: Electronic Cigarette Experimental Treatment 2 Interventions

Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).

Group II: Nicotine Replacement Therapy Active Control 2 Interventions

Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).

National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electronic Cigarettes for:

• Nicotine replacement therapy for smoking cessation
• Harm reduction for smokers with opioid use disorder

Approved in European Union as E-Cigs for:

• Nicotine replacement therapy for smoking cessation

Approved in Canada as Vaporizers for:

• Nicotine replacement therapy for smoking cessation

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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]

Tobacco companies initially opposed nicotine replacement therapy (NRT) due to fears it would lead to stricter regulations on cigarettes, but later recognized its potential market value and began developing their own NRT products.

Research shows that many smokers use NRT to supplement their smoking rather than to quit, which led tobacco companies to shift their strategy and embrace NRT as a way to maintain nicotine consumption among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Industry Research on Nicotine Replacement Therapy: "If Anyone Is Going to Take Away Our Business It Should Be Us". Apollonio, D., Glantz, SA.[2018]

Smokers with opioid use disorder (OUD) showed lower adherence to varenicline (VAR) compared to nicotine patches, suggesting that nicotine replacement therapy (NRT) may be more suitable for this group.

While both groups had similar smoking cessation outcomes, smokers with OUD experienced significantly more drug use days when treated with VAR compared to NRT, indicating potential challenges in managing substance use alongside smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokers with opioid use disorder may have worse drug use outcomes after varenicline than nicotine replacement. Martin, RA., Rohsenow, DJ., Tidey, JW.[2023]

A comprehensive analysis of 8,867,135 reports from the FDA Adverse Event Reporting System revealed that nicotine replacement therapies (NRTs) are associated with several adverse events, including nausea, dizziness, and application site reactions, indicating the need for careful monitoring of their use.

Electronic cigarettes also reported adverse events such as dizziness and increased heart rate, suggesting that while they may be used for smoking cessation, they are not without risks and should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016. Motooka, Y., Matsui, T., Slaton, RM., et al.[2022]

In a study involving 91 patients and 10 clinicians at Australian opioid agonist treatment clinics, most patients had attempted to quit smoking, with 43% currently trying, but reported low rates of intervention from clinicians regarding smoking cessation medications.

Patients preferred e-cigarettes for smoking cessation but had more exposure to nicotine replacement therapy (NRT), while clinicians recognized the high prevalence of tobacco use yet provided few smoking cessation interventions, indicating a gap in support and knowledge about cessation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do patients and staff in an opioid agonist treatment service view smoking cessation medications and e-cigarettes? Lobbe, C., Bahnisch, J., Lin, C., et al.[2023]

E-cigarettes were found to be more effective than nicotine-replacement therapy (NRT) for achieving continuous smoking abstinence for 6 months or longer, with a relative risk of 1.67 based on a meta-analysis of 5 randomized controlled trials involving 1748 participants.

There were no significant differences in adverse events between e-cigarettes and NRT, except for increased throat irritation associated with e-cigarettes, indicating a similar safety profile overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. Li, J., Hui, X., Fu, J., et al.[2022]

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]

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]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

In a study of 222 adults undergoing treatment for opioid use disorder, 72% were current smokers, and there was a moderate level of interest in using e-cigarettes for smoking cessation, with 44% expressing interest in future use.

Participants who had previously used e-cigarettes for quitting were more likely to consider them as a cessation tool, although some expressed concerns about potentially replacing one addiction with another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in Electronic Cigarettes for Smoking Cessation Among Adults With Opioid Use Disorder in Buprenorphine Treatment: A Mixed-Methods Investigation. Streck, JM., Regan, S., Neil, J., et al.[2023]

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