E-cigarette for Mental Disorders

1
Effectiveness
1
Safety
Montefiore Behavioral Health Center, Bronx, NY
Mental Disorders+3 More
E-cigarette - Other
Eligibility
18+
All Sexes
Eligible conditions
Mental Disorders

Study Summary

This study is evaluating whether electronic cigarettes may help smokers with psychiatric disorders quit smoking.

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Eligible Conditions

  • Mental Disorders
  • Problem Behavior
  • Tobacco Smoking Behavior
  • Psychiatric Disorders

Treatment Effectiveness

Study Objectives

This trial is evaluating whether E-cigarette will improve 5 primary outcomes and 2 secondary outcomes in patients with Mental Disorders. Measurement will happen over the course of Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

Week 12
Changes in Motivation/Readiness to Quit Smoking
Changes in Nicotine Dependence
Changes in Withdrawal Symptoms
Changes in the use of e-cigarettes
Rates of those who completely switched to e-cigarettes
Week 12
Changes in the number of combustible cigarettes smoked per day
Week 12
Changes in Carbon Monoxide Level

Trial Safety

Trial Design

2 Treatment Groups

Control
E-cigarette

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. E-cigarette is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

E-cigarette
Other
All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks for reporting.

Closest Location

Montefiore Behavioral Health Center - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
current daily smokers (i.e., at least 5 cigarettes/day)
attended a minimum of 2 treatment visits in the past 12 months at Montefiore Behavioral Health Center
21 years of age or older
English-speaking
have been daily smokers at least for 6 months
have at least one psychiatric disorder (other than substance use disorders)
willing to try switching to use e-cigarettes (provided by the research team) exclusively for a total of 8 weeks
those who are not yet ready to quit smoking
for women of childbearing age, willingness to use contraception during the study.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is e-cigarette safe for people?

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E-cigarette use in people with mental health problems is not associated with significant psychiatric comorbidity. E-cigarette use among people with mental health problems is a relatively low risk behavior with few significant adverse outcomes.

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Can mental disorders be cured?

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There are important ethical, religious and social reasons for seeking a 'cure' for mental disorders. But there remain a significant number of patients for whom the disease has a cure; some of whom will need psychiatric and social support.

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What are the signs of mental disorders?

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Symptoms of mental disorders may include feelings of sadness, irritability, low mood, anger, anxiety, depression, paranoia, confusion, restlessness, inability to concentrate, guilt, guilt, irritability, anorexia, insomnia, insomnia and hallucinations.\n

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How many people get mental disorders a year in the United States?

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Roughly 10 million Americans suffer from some form of mental disorder a year. More than 1.5 million people receive mental health services each year for one of these disorders. Most common are mood disorders and anxiety disorders.

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What causes mental disorders?

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In the United States, [mental disorders such as major depression and anxiety disorders], have been observed during the early and middle years of life. What follows this initial observation is speculation [and] speculation about causation. One can expect that the mechanisms of occurrence of [these disorders] are different from age group to age group. [A lack of correlation between mental disorders and age] may reflect a lack of studies. As more [research] gets reported, we will hopefully refine our current hypotheses and add to [our knowledge] of this [process].

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What is mental disorders?

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There are many different types of mental disorders. They often affect a person's thoughts, feelings, behaviour, attention, and decisions. When people have a mental disorder, it is challenging for them to lead healthy lives, but when people are able to lead healthy lives, they can lead the world to a positive future. Those with mental health issues can build relationships with others and get the support they need.\n

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What are common treatments for mental disorders?

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The most common treatment for mental disorders is psychoanalysis and pharmacotherapy, such as medication or cognitive therapies. More recently, noninvasive technologies like PET scans, PET-MRI, fMRI, and MRS have been used to enhance diagnostic procedures in anxiety and mood disorders.\n

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Have there been other clinical trials involving e-cigarette?

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There have been several clinical trials in which patients did not self-report experiencing an adverse event. Therefore, it is still possible that e-cigarette has adverse effects, but that patients not experience e-lung toxicity. However, according to the current evidence, patients were not well advised and lack of knowledge on how to use e-cigarette for treatment. Therefore, e-cigarette is harmful.

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What does e-cigarette usually treat?

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There is an urgent need for additional scientific studies on e-cigarette use, particularly among adolescents and young adults. Especially to ascertain if e-cigarette use increases the chances of developing mental disorders. Also, studies are needed to determine if other constituents of e-cigarettes have similar physiological effects on the brain and if they might be harmful as well.

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What is the primary cause of mental disorders?

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All patients with mental disturbance and/or depression should be considered to suffer from chronic inflammatory diseases for which chronic inflammatory and pro-inflammatory factors should be considered among the several mechanisms responsible for the onset and maintenance of mental disorders and depressive symptoms.

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Is e-cigarette typically used in combination with any other treatments?

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This is the first systematic review to describe the e-cigarette use in patients with any other treatments. The use of e-cigarettes seems to be low (1.2%). More data from studies and long-term studies should be performed to gain further insight in this subject.

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Have there been any new discoveries for treating mental disorders?

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There have been many discoveries on treating psychiatric disorders, but only a few have been used in daily practice. In fact, the only effective treatment in some places in the world nowadays is a specific drug (for example Prozac in the USA) or an antidepressant drug. This is one of the weaknesses of the treatments; they do not give full recovery. It is important to emphasize that psychiatric disease should be treated, but in the future a combination of treatments should be done.

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