E-cigarettes + NRT for Smoking Reduction in Mental Illness

Overseen By Izamar Gallardo Castillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Substance use disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well e-cigarettes and nicotine replacement therapies (such as patches and lozenges) assist individuals with serious mental illnesses in reducing smoking. Participants receive motivational counseling and supportive text messages to help decrease cigarette use. The trial suits adults who smoke at least five cigarettes daily, have a mental health condition like depression or bipolar disorder, and wish to reduce smoking without quitting entirely. Participants should have regular access to a mobile phone and be prepared to engage with the study.

As an unphased trial, this study provides a unique opportunity for participants to contribute to valuable research that could enhance smoking reduction strategies for those with mental health conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have changed the dose of your psychotropic medication in the last 30 days, you cannot participate.

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

Research has shown that nicotine replacement therapies (NRT), such as patches and lozenges, are generally safe and easy to use. Many people have used them to quit smoking, and they usually cause mild side effects, like skin irritation from patches or mouth soreness from lozenges.

Studies on e-cigarettes (EC) show mixed results. Some research suggests e-cigarettes might help reduce smoking, but they also pose risks. These include addiction, inhaling harmful chemicals, and possible injuries from device malfunctions. Links have also been found between vaping and mental health issues, such as depression and anxiety.

In summary, many people have used both NRT and e-cigarettes. NRT is generally considered safe, but e-cigarettes present some concerning health risks. Anyone considering these options should carefully weigh these safety factors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using e-cigarettes combined with nicotine replacement therapies (NRT) for smoking reduction in individuals with mental illness because this approach offers a novel way to tackle nicotine addiction. Unlike traditional NRT options like patches and lozenges alone, this method incorporates e-cigarettes, which may better simulate the experience of smoking and potentially make the transition away from cigarettes more manageable. This combination aims to address both the physical and behavioral aspects of smoking addiction, providing an innovative strategy that could increase success rates.

What evidence suggests that this trial's treatments could be effective for smoking reduction in mental illness?

Research has shown that e-cigarettes can be as effective as nicotine replacement products, such as patches or gum, for those trying to reduce or quit smoking. Studies have found that e-cigarettes are equally effective, safe, and accepted by individuals with mental health issues as by those without. People with mental health conditions often find it harder to stop smoking, but e-cigarettes might offer a helpful alternative. This trial will compare two treatment arms: one where participants receive e-cigarettes and another where participants receive nicotine replacement therapy (NRT) products. The aim is to reduce reliance on regular cigarettes, which are more harmful. Both e-cigarettes and nicotine replacement products are being studied to assess their effectiveness in helping people with serious mental health issues reduce smoking. ^{1 2 5 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 Serious Mental Illness who smoke cigarettes regularly and are interested in reducing smoking but not necessarily quitting. They must be able to consent, have a mobile phone, and not be pregnant or breastfeeding. Those using non-cigarette tobacco recently or with recent changes in psychotropic meds, substance abuse issues, or acute psychiatric crises cannot join.

Inclusion Criteria

I am willing and able to give my consent for treatment.

I have been diagnosed with a serious mental illness like schizophrenia or bipolar disorder.

Currently smokes 5 or more CPD

Exclusion Criteria

Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders

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

Is 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 harm-reduction counseling and Ecological Momentary Intervention text messaging along with either e-cigarettes or nicotine replacement therapy for smoking reduction

8 weeks

Telehealth motivational counseling sessions

Follow-up

Participants are monitored for smoking behavior changes and health outcomes

4 weeks

Long-term Follow-up

Participants' smoking behavior and health outcomes are assessed up to Week 12

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E-cigarette (EC)
• Ecological Momentary Intervention (EMI) Text Messaging
• Harm-Reduction Counseling
• Nicotine Replacement Therapy (NRT)

Trial Overview Participants will receive counseling and text message interventions aimed at harm reduction from smoking. They'll randomly get either e-cigarettes (EC) or nicotine replacement therapy (NRT), like patches or gums, to see which helps more in cutting down cigarette use among those with mental illness.

How Is the Trial Designed?

Group I: E-cigarettes (EC) Experimental Treatment 3 Interventions

Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.

Group II: Nicotine Replacement Therapy (NRT) Active Control 3 Interventions

Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.

E-cigarette (EC) is already approved in United Kingdom, Canada for the following indications:

Approved in United Kingdom as Electronic cigarette for:

• Nicotine replacement therapy for smoking cessation

Approved in Canada as E-cigarette for:

• Nicotine replacement therapy for smoking cessation

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study involving 310 acute psychiatric inpatients, nicotine inhalers were found to significantly reduce exhaled carbon monoxide levels compared to baseline at both 4 and 8 weeks, indicating effective smoking reduction.

Nicotine inhalers also led to greater decreases in nicotine withdrawal symptoms and psychiatric symptom severity compared to nicotine patches and gum, suggesting they may be the most beneficial form of nicotine replacement therapy in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine Replacement Therapy and Healthy Lifestyle Psychoeducation for Smoking Reduction in Acute Psychiatric Inpatients: A Cluster-Randomized Parallel Study. Chan, HY., Chen, JJ., Pan, YJ., et al.[2021]

In a study of 150 participants, e-cigarettes were found to be as effective as nicotine gum for smoking cessation, with no significant differences in overall abstinence rates.

E-cigarettes were associated with a higher proportion of participants showing smoking reduction at 24 weeks and had fewer adverse events compared to nicotine gum, suggesting they may be a safer alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. Lee, SH., Ahn, SH., Cheong, YS.[2020]

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]

A systematic review of 44 studies, including 31 randomized controlled trials, found that alternative tobacco and nicotine products like electronic cigarettes (EC), smokeless tobacco, and nicotine replacement therapy (NRT) can moderately reduce daily cigarette consumption and assist in smoking cessation with fewer adverse events.

The evidence supports the potential role of these products in tobacco harm reduction, but further research is needed to evaluate their long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review. Zakiyah, N., Purwadi, FV., Insani, WN., et al.[2023]

Individuals with mental illness face significant challenges with smoking, spending up to 40% of their income on tobacco and experiencing higher mortality rates from related health issues.

Effective smoking cessation interventions for psychiatric patients, such as psychological treatments and nicotine replacement therapy, show similar short-term success rates as in the general population, but long-term success is best achieved through extended support and tailored programs that consider individual patient factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of smoking cessation therapies in individuals with psychiatric illness : an update for prescribers. Kisely, S., Campbell, LA.[2021]

E-cigarettes may serve as a useful tool for smoking cessation or temporary abstinence in mental health settings, particularly in inpatient units, amidst smoke-free policies.

The article discusses the complexities of smoking among individuals with mental disorders and the ongoing debate about the role of e-cigarettes in supporting smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes in mental health settings - solving a conundrum? Ratschen, E.[2022]

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]

Combination treatment with varenicline and nicotine replacement therapy (NRT) was found to be safe and well tolerated, with 39% of patients experiencing adverse events compared to 59% in the usual-care group.

There was no significant difference in smoking abstinence rates at 6 months between the combination therapy group (54%) and the usual-care group (59%), indicating that while the combination is safe, it may not provide a greater efficacy in smoking cessation compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and nicotine replacement therapy. Ebbert, JO., Burke, MV., Hays, JT., et al.[2022]

The best way to stop smoking is by using both professional counseling and medications, especially for those who are nicotine dependent and motivated to quit.

Combination nicotine replacement therapy, such as using a patch along with an oral product, is more effective than using a patch alone, and varenicline is highlighted as the most effective oral medication for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal use of smoking cessation pharmacotherapy. Mendelsohn, C.[2023]

In a randomized controlled trial with 135 smokers who struggled to quit using traditional methods, e-cigarettes (EC) led to a significantly higher rate of smoking reduction (26.5%) compared to nicotine replacement therapy (NRT) (6.0%), indicating greater efficacy for e-cigarettes in this population.

E-cigarettes also resulted in higher sustained abstinence rates at 6 months (19.1%) compared to NRT (3.0%), suggesting that e-cigarettes may be a more effective long-term solution for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial. Myers Smith, K., Phillips-Waller, A., Pesola, F., et al.[2022]

Mental health professionals (MHPs) are generally cautious about the safety and suitability of electronic cigarettes (ECs) for tobacco harm reduction, influenced by a lack of clear information and exposure to negative perceptions about ECs.

Despite some MHPs recognizing the potential benefits of ECs in helping patients reduce smoking, misconceptions and a risk-averse mindset limit their willingness to incorporate ECs into treatment, highlighting the need for better education and guidance on this topic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health professionals' perceptions, judgements and decision-making practices regarding the use of electronic cigarettes as a tobacco harm reduction intervention in mental healthcare: A qualitative focus group study. Smith, CA., McNeill, A., Kock, L., et al.[2022]

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