E-Cigarettes for Smokers With Mental Illness

Recruiting at 1 trial location

Overseen By Meghan M. Santos, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Asthma, Cognitive impairment, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how e-cigarettes might help smokers with mental health conditions reduce harm, even if they are not ready to quit smoking completely. It compares two approaches: using e-cigarettes alone (E-cig Provision Only) or alongside telehealth-based behavioral support (SWITCH IT). The researchers aim to determine if e-cigarettes can help manage stress and improve confidence in reducing smoking. Individuals who smoke daily, have been diagnosed with schizophrenia, bipolar disorder, major depression, PTSD, or anxiety, and have tried quitting before but are not interested in stopping now might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore new ways to reduce smoking-related harm while managing mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that using e-cigarettes carries some risks. Users have reported feeling depressed and having thoughts of suicide more often than non-users. Most e-cigarettes contain nicotine, which is addictive and harmful to health. However, one study found that smokers with mental illness who used e-cigarettes for eight weeks smoked fewer regular cigarettes and had lower levels of carbon monoxide, a positive outcome.

The SWITCH IT program also uses e-cigarettes but includes extra support to help manage smoking. This approach aims to reduce harm from smoking while assisting people in handling stress. Although e-cigarettes can have side effects, they might help people smoke fewer regular cigarettes, which could be better for health in the short term.

Overall, while e-cigarettes are not risk-free, they may help reduce regular cigarette use, especially with additional support like SWITCH IT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SWITCH IT approach because it combines e-cigarettes with behavioral support and coaching specifically designed for smokers with mental illness. Unlike traditional cessation methods like nicotine replacement therapies or prescription medications, this method not only provides a potentially less harmful nicotine source but also integrates personalized coaching, which can be crucial for this population. This dual approach aims to address both the physical dependency and the behavioral aspects of smoking, potentially leading to more effective and sustainable outcomes.

What evidence suggests that this trial's treatments could be effective for smokers with mental illness?

Studies have shown that e-cigarettes can help people quit smoking. For those with mental health challenges, e-cigarettes work as well as traditional nicotine-replacement therapies. In this trial, one group will receive only e-cigarettes, which previous research has shown can lead to smoking fewer cigarettes daily and reducing carbon monoxide levels over a short period, such as 8 weeks. Another group will receive e-cigarettes along with behavioral support and coaching. Research indicates that adding support, like counseling, to e-cigarette use can increase the chances of quitting. These findings suggest that using e-cigarettes alone or with support can help smokers with mental illness reduce smoking. ^{2 6 7 8 9}

Who Is on the Research Team?

Sarah I. Pratt, PhD

Principal Investigator

Dartmouth Health

Are You a Good Fit for This Trial?

This trial is for smokers with mental illness who can't quit smoking and aren't ready to try quitting. Participants must be willing to use e-cigarettes and have access to telehealth services.

Inclusion Criteria

I am over 21, smoke daily, tried to quit once before, but don't want to quit now.

I have been diagnosed with a mental health condition such as schizophrenia, bipolar disorder, depression, PTSD, or an anxiety disorder.

Exclusion Criteria

Participation in the pilot study of SWITCH IT (at Seven Counties Services site)

Cognitive impairment, as indicated by a score <26 on the Telephone Interview for Cognitive Status (TICS)

Current use of e-cigarettes (>once a week)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a supply of e-cigarettes with or without behavioral support for harm reduction

8 weeks

Telehealth sessions

Follow-up

Participants are monitored for changes in CO levels, urine NNAL, and self-reported cigarette use

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E-cig Provision Only
• SWITCH IT

Trial Overview

The study tests if providing e-cigarettes, with or without behavioral support called SWITCH IT via telehealth, helps reduce harm in smokers with mental illness not seeking cessation treatment.

How Is the Trial Designed?

Group I: SWITCH IT Experimental Treatment 1 Intervention

Participants randomized to this condition will receive a supply of e-cigarettes and behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study.

Group II: E-cigarette provision only Active Control 1 Intervention

Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Fordham University

Collaborator

Trials

21

Recruited

4,100+

Western Michigan University School of Medicine

Collaborator

Trials

6

Recruited

560+

Seven Counties Services

Collaborator

Trials

1

Recruited

250+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Despite a significant decline in smoking rates since 1964, about 12.5% of Americans still smoke, particularly among marginalized groups with behavioral health conditions, highlighting a need for targeted cessation strategies.

The proposal to use electronic cigarettes as a smoking cessation tool for individuals with behavioral health conditions is timely and evidence-based, aiming to address the unique challenges faced by this population and potentially save hundreds of thousands of lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarettes: an Overlooked Tool to Alleviate Disparities in Tobacco Use Disorder Among People with Mental Health and Substance Use Disorders. Vuong, JT., Ruedisueli, I., Beaudin, CS., et al.[2023]

Adults with chronic mental illnesses, such as depression and anxiety, are significantly more likely to try and use e-cigarettes compared to those without mental health issues, according to data from the 2016 National Health Interview Survey involving a nationally representative sample.

The increased e-cig use among individuals with chronic mental illness may stem from beliefs that e-cigarettes are less harmful than traditional cigarettes and their potential to facilitate social connections, highlighting a need for further research on the health implications of e-cig use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of electronic cigarette use among adults with a chronic mental illness. Bianco, CL.[2020]

Among 162 adult daily smokers with schizophrenia, 46% reported ever using e-cigarettes, with 15% currently using them, indicating a significant prevalence of e-cigarette use in this population.

Younger age was the strongest predictor of e-cigarette use, and current e-cigarette users had lower carbon monoxide levels compared to past users, suggesting potential harm reduction benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of and reasons for electronic cigarette use among adult smokers with schizophrenia/schizoaffective disorder. Wong, JA., Pratt, SI., Ferron, JC., et al.[2022]

In a study of 956 adult smokers with serious mental illness, electronic cigarette (EC) use increased from 0% in 2009 to 25% in 2013, particularly among younger adults and those planning to quit smoking.

Despite the rise in EC use, it did not lead to significant changes in smoking behavior or reductions in the number of cigarettes smoked per day over the 18-month trial period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette use among smokers with serious mental illness. Prochaska, JJ., Grana, RA.[2022]

The STATUS trial is investigating the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in adults with mental health issues and/or alcohol and other drug addictions, aiming to improve quit rates in this population.

Participants who do not show a significant reduction in smoking after 2 weeks of varenicline will be randomized to either continue with varenicline alone or add nicotine e-cigarettes for 10 weeks, with the primary outcome being biochemically-verified continuous abstinence at 24 weeks post-randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial. Bullen, C., Verbiest, M., Galea-Singer, S., et al.[2019]

Smokers with serious psychological distress (SPD) showed a greater intention to completely switch to e-cigarettes and seek help for quitting compared to those without SPD, indicating a potential optimism about e-cigarettes as a cessation tool.

Despite being exposed to messages about the reduced harm of e-cigarettes, smokers with SPD perceived a higher absolute risk of both e-cigarettes and traditional cigarettes, suggesting that they may not fully accept e-cigarettes as a safer alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological distress and responses to comparative risk messages about electronic and combusted cigarettes. Yang, B., Spears, CA., Popova, L.[2022]

In a study of 6051 U.S. adults, those with mental health conditions (MHC) were found to be 1.5 times more likely to have used electronic nicotine delivery devices (ENDS) and nearly twice as likely to currently use them compared to those without MHC.

Former smokers with MHC showed a particularly strong association with ENDS use, indicating that while ENDS may help some quit smoking, they could also attract former smokers with MHC back to nicotine use, raising concerns about their overall effectiveness for cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Electronic Nicotine Delivery Systems among Adults with Mental Health Conditions, 2015. Spears, CA., Jones, DM., Weaver, SR., et al.[2018]

E-cigarette use is common among adults with mental illness, who often use them alongside traditional combustible tobacco, suggesting they see e-cigarettes as a potential alternative.

Current evidence indicates that e-cigarettes do not seem to worsen nicotine addiction or psychiatric symptoms in this population, but the long-term effects on overall health and tobacco use patterns remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes and mental illness: Reviewing the evidence for help and harm among those with psychiatric and substance use disorders. Hefner, K., Valentine, G., Sofuoglu, M.[2022]

People with serious mental illness have a high rate of smoking, which significantly contributes to their health problems and early deaths, highlighting the urgent need for effective smoking cessation support.

The authors suggest using harm reduction strategies like nicotine replacement therapy and e-cigarettes as alternatives for those who cannot quit smoking, along with providing smoking cessation support in smoke-free psychiatric units during and after hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of reducing smoking in people with serious mental illness. Sharma, R., Gartner, CE., Hall, WD.[2018]

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