E-Cigarettes for Smokers With Mental Illness
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen bySarah I. Pratt, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dartmouth-Hitchcock Medical Center
Disqualifiers: Asthma, Cognitive impairment, Pregnancy, others
No Placebo Group
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.
12345Is 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.
12456How 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.
14789Eligibility 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)
+7 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: SWITCH ITExperimental Treatment1 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 onlyActive Control1 Intervention
Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Homer Stryker MD School of Medicine (WMed)Kalamazoo, MI
Seven Counties ServicesLouisville, KY
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Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
Fordham UniversityCollaborator
Western Michigan University School of MedicineCollaborator
Seven Counties ServicesCollaborator
Dartmouth CollegeCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
E-cigarette use among smokers with serious mental illness. [2022]We examined electronic cigarette (EC) use, correlates of use, and associated changes in smoking behavior among smokers with serious mental illness in a clinical trial.
Characteristics of and reasons for electronic cigarette use among adult smokers with schizophrenia/schizoaffective disorder. [2022]The objective of our study was to determine lifetime and current e-cigarette use among adult cigarette smokers with schizophrenia or schizoaffective disorder, and to describe characteristics of these e-cigarette users.
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]Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions.
Electronic Cigarettes: an Overlooked Tool to Alleviate Disparities in Tobacco Use Disorder Among People with Mental Health and Substance Use Disorders. [2023]The remarkable decline in cigarette smoking since 1964 has plateaued; approximately 12.5% of Americans still smoke. People who continue to smoke are largely members of marginalized groups, such as people with behavioral health conditions (BHC), encompassing both mental health and substance use disorders. Certified smoking cessation interventions can increase smoking abstinence in trials in people with BHC, yet smoking rates remain markedly increased, leading to increased mortality from smoking-related diseases, and worsening health disparities. A novel approach tailored to the unique needs, characteristics, and circumstances of people with BHC is mandated. One promising approach, the electronic cigarette, has not been embraced in the USA, likely due to an understandable concern for non-smoking young people among whom electronic cigarettes have been popular. Recent data confirm that electronic cigarette use is declining among young people, yet cigarette smoking is not declining among people with BHC. We propose smoking cessation trials utilizing electronic cigarettes in people with BHC. To this goal, the UK has already begun allowing companies to submit their products for approval as medically licensed electronic cigarettes that can be prescribed as smoking cessation aids. Our proposal is timely, backed by evidence, and aims to save hundreds of thousands of American lives.
Use of Electronic Nicotine Delivery Systems among Adults with Mental Health Conditions, 2015. [2018]Adults with mental health conditions (MHC) are especially likely to smoke and experience tobacco-related health disparities. Individuals with MHC may also use electronic nicotine delivery devices (ENDS) at disproportionately high rates. However, there is a relative dearth of knowledge regarding ENDS use among individuals with MHC. In a large representative sample of U.S. adults (n = 6051), associations between self-reported MHC diagnoses and ENDS use and susceptibility were examined, stratified by smoking status. Participants with MHC were approximately 1.5 times more likely to have used ENDS in their lifetime and almost twice as likely to currently use ENDS as those without MHC. MHC status was most strongly linked to higher ENDS use among former smokers, and former smokers with MHC were more likely to report using ENDS during past smoking quit attempts than those without MHC. Among participants who had not tried ENDS, former smokers with MHC were especially susceptible to future ENDS use. The potential advantage of ENDS for cessation purposes should be balanced with the risk of attracting former smokers with MHC to ENDS.
Psychological distress and responses to comparative risk messages about electronic and combusted cigarettes. [2022]People with mental illness suffer disproportionately high health burdens of smoking. Communicating to these smokers that electronic cigarettes (e-cigarettes) are a less harmful alternative to combusted cigarettes might help them reduce their health risks by encouraging complete switching to e-cigarettes. However, such messages might also cause unintended consequences (e.g., dual use of both combusted and e-cigarettes). Our study examined how smokers with vs. without serious psychological distress (SPD) responded to messages communicating reduced harm of e-cigarettes in relation to cigarettes.
Rates of electronic cigarette use among adults with a chronic mental illness. [2020]Electronic cigarette (e-cig) use has increased dramatically over the past decade, rates of e-cig use among those with a chronic mental illness has largely been unexplored. Exploring this relationship for adults with a mental illness is necessary when examining the health needs of this population.
The challenge of reducing smoking in people with serious mental illness. [2018]The high prevalence of smoking in people with serious mental illness contributes substantially to the disproportionately high morbidity and premature mortality in this population. There is an urgent need to help people with serious mental illness to quit smoking. We discuss competing explanations for the high prevalence of smoking in people with serious mental illness and the effectiveness of available smoking cessation interventions. We propose trials of harm reduction options, such as nicotine replacement therapy and electronic cigarettes (e-cigarettes), as long-term substitutes for cigarettes in smokers with serious mental illness who are unable to quit smoking. We also propose that smoke-free psychiatric units provide smoking cessation support on patient admission to the hospital and after discharge.
Electronic cigarettes and mental illness: Reviewing the evidence for help and harm among those with psychiatric and substance use disorders. [2022]Adults with mental illness (MI) use combustible tobacco at increased rates and have greater difficulty quitting smoking. Given the increasing popularity of electronic cigarettes (e-cigarettes), their use by those with MI has important health implications. While preliminary evidence suggests potential benefits of e-cigarette use for those with MI, well-controlled, systematic research examining appeal, correlates, and consequences of e-cigarette use in this vulnerable population is lacking. This review evaluated current knowledge of e-cigarette use and potential for help and/or harm among adults with MI.