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

Trial Summary

What is the purpose of this trial?

To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT

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.

What data supports the effectiveness of the treatment E-cig Provision Only for smokers with mental illness?

Research suggests that electronic cigarettes may help people with mental health conditions quit smoking, as they are more likely to use these devices during quit attempts. Additionally, electronic cigarettes are being considered as a promising approach to reduce smoking rates among people with mental health and substance use disorders, potentially saving lives. ^{1 2 3 4 5}

Is it safe for people with mental illness to use e-cigarettes?

Research suggests that e-cigarettes might be a less harmful alternative to traditional cigarettes for people with mental illness, but there are concerns about dual use (using both e-cigarettes and regular cigarettes) and attracting former smokers back to nicotine use. ^{1 2 4 5 6}

How is the SWITCH IT treatment different from other treatments for smokers with mental illness?

The SWITCH IT treatment is unique because it involves providing e-cigarettes along with behavioral support to help smokers with mental illness quit smoking. This approach is novel as it combines a harm reduction strategy using e-cigarettes, which are less harmful than traditional cigarettes, with behavioral support tailored to the needs of individuals with mental health conditions. ^{1 4 7 8 9}

Research Team

Sarah I. Pratt, PhD

Principal Investigator

Dartmouth Health

Eligibility Criteria

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)

I have been diagnosed with asthma.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

E-cigarette use among smokers with serious mental illness. [2022]

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

Characteristics of and reasons for electronic cigarette use among adult smokers with schizophrenia/schizoaffective disorder. [2022]

3. England 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. [2019]

4. United States 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Electronic Nicotine Delivery Systems among Adults with Mental Health Conditions, 2015. [2018]

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

Psychological distress and responses to comparative risk messages about electronic and combusted cigarettes. [2022]

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

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

8. England pubmed.ncbi.nlm.nih.gov

The challenge of reducing smoking in people with serious mental illness. [2018]

9. England 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. [2022]