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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Omar El-Shahawy

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: NYU Langone Health

Must be taking: Methadone, Buprenorphine

Disqualifiers: Pregnancy, COPD, Asthma, Depression, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (OUD) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (OUDTP)). OUDTP patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. If effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.

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.

What data supports the effectiveness of this treatment for smoking cessation in individuals with opioid use disorder?

Research suggests that traditional smoking cessation methods have low success rates in individuals with opioid use disorder, but electronic cigarettes (e-cigarettes) are being explored as a novel option. Some studies indicate that e-cigarettes might be more acceptable and feasible for this population, although controlled trials are still needed to confirm their effectiveness. ^{1 2 3 4 5}

Is the combination of e-cigarettes and nicotine replacement therapy safe for people with opioid use disorder?

Research has shown that both e-cigarettes and nicotine replacement therapy (NRT) are widely used for smoking cessation, and their safety has been evaluated in various studies. The US Food and Drug Administration Adverse Event Reporting System has recorded adverse events related to these treatments, but they are generally considered safe for use in humans. ^{2 3 6 7 8}

How is the treatment of e-cigarettes combined with NRT and counseling unique for smoking cessation in opioid use disorder?

This treatment is unique because it combines e-cigarettes with nicotine replacement therapy (NRT) and counseling, offering a multi-faceted approach that may be more effective for individuals with opioid use disorder who have struggled with traditional smoking cessation methods. E-cigarettes provide a similar experience to smoking, which might help reduce cravings, while NRT provides a controlled dose of nicotine to ease withdrawal symptoms. ^{1 2 5 9 10}

Research Team

Omar El-Shahawy

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Has a diagnosis of Opioid Use Disorder

Exclusion Criteria

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

I do not speak English or Spanish.

Are pregnant or breastfeeding

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Smokers with opioid use disorder may have worse drug use outcomes after varenicline than nicotine replacement. [2023]

2. England pubmed.ncbi.nlm.nih.gov

An Open Trial of Electronic Cigarettes for Smoking Cessation Among Methadone-Maintained Smokers. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A pilot investigation of the effect of electronic cigarettes on smoking behavior among opioid-dependent smokers. [2020]

4. England 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. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

How do patients and staff in an opioid agonist treatment service view smoking cessation medications and e-cigarettes? [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]

7. England 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. [2022]

8. Greece pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. [2022]

9. United States 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". [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Perceptions of E-cigarettes among adults in treatment for opioid use disorder. [2023]