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

Trial Summary

What is the purpose of this trial?

In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch and lozenges to compare the efficacy in CC smoking reduction.

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.

What data supports the effectiveness of this treatment for smoking reduction in individuals with mental illness?

Research shows that combining professional counseling with nicotine replacement therapy (NRT) is effective for quitting smoking. E-cigarettes (vapes) are considered a second-line treatment for those who struggle to quit with other methods, and they may be useful in mental health settings as a smoking cessation aid. ^{1 2 3 4 5}

Is the combination of e-cigarettes and nicotine replacement therapy safe for humans?

Research shows that both e-cigarettes and nicotine replacement therapy (NRT) are being studied for their safety and effectiveness in helping people reduce or quit smoking. While specific safety data for the combination of these treatments is limited, they are generally considered safe for human use in smoking cessation efforts. ^{2 6 7 8 9}

How is the treatment of E-cigarettes and NRT for smoking reduction in mental illness different from other treatments?

This treatment is unique because it combines e-cigarettes, which mimic the act of smoking, with traditional nicotine replacement therapies like gum or patches, offering a dual approach to help people with mental illness reduce smoking. This combination may be particularly helpful for those who find it hard to quit smoking entirely, providing both a physical and behavioral substitute for cigarettes. ^{2 5 8 10 11}

Research Team

Omar El-Shahawy

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Optimal use of smoking cessation pharmacotherapy. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Use of smoking cessation therapies in individuals with psychiatric illness : an update for prescribers. [2021]

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

Nicotine Replacement Therapy and Healthy Lifestyle Psychoeducation for Smoking Reduction in Acute Psychiatric Inpatients: A Cluster-Randomized Parallel Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Electronic cigarettes in mental health settings - solving a conundrum? [2022]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and nicotine replacement therapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial. [2022]

11. Netherlands 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. [2022]