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Search / Trial NCT04014322

The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment

Launched by FORDHAM UNIVERSITY · Jul 8, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Electronic Cigarette Use Smoking Behavior

ClinConnect Summary

This clinical trial is studying how using electronic cigarettes (e-cigarettes) affects smoking behaviors among people with psychiatric disorders who are not ready to quit smoking. The goal is to see if switching from traditional cigarettes to e-cigarettes can help them reduce their smoking. Participants in this study must be at least 21 years old, speak English, and currently smoke at least five cigarettes a day for at least six months. They also need to have attended treatment at Montefiore Behavioral Health Center in the past year and have at least one psychiatric disorder.

If you join the study, you'll be asked to use e-cigarettes exclusively for eight weeks. The research team will provide the e-cigarettes and check in with you at the beginning, and then at two, four, eight, and twelve weeks to see how you’re doing. It's important to know that this study is for those who are not actively trying to quit smoking, so if you’re currently trying to stop or have other health issues, you might not qualify. This study aims to help understand the potential benefits of e-cigarettes for smokers in a high-risk group, which could lead to better support and treatment options in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 21 years of age or older
  • English-speaking,
  • current daily smokers (i.e., at least 5 cigarettes/day)
  • have been daily smokers at least for 6 months
  • attended a minimum of 2 treatment visits in the past 12 months at Montefiore Behavioral Health Center
  • 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.
  • Exclusion Criteria:
  • acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
  • current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
  • patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
  • current clinical diagnosis of intellectual development disorder
  • current regular use of other tobacco products or combustible marijuana
  • current (non-nicotine) substance use disorder and current substance use (in the past month)
  • current effort to quit smoking or current use of pharmacotherapy (in the past month) to quit smoking,
  • pregnant, breastfeeding, or planning to become pregnant within 6 months, current unstable cardiovascular disease,
  • current unstable pulmonary disease (i.e., an ER visit or hospitalization due to pulmonary issues in the past 6 month or current use of oxygen therapy),
  • patient does not have a stable home address where the research team could reliably reach patient
  • household members are currently participating or have participated in this research study

About Fordham University

Fordham University is a prestigious institution known for its commitment to academic excellence and research innovation. As a clinical trial sponsor, Fordham University leverages its extensive resources and expertise to advance medical research and contribute to the development of effective therapies. With a focus on ethical standards and regulatory compliance, the university fosters collaborative partnerships with healthcare professionals and industry leaders to ensure the integrity and success of clinical trials. Through its dedicated research initiatives, Fordham University aims to enhance patient care and promote health advancements in the community and beyond.

Locations

Bronx, New York, United States

Patients applied

KS

EW

2 patients applied

Trial Officials

Haruka Minami, Ph.D.

Principal Investigator

Fordham University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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