~10 spots leftby Apr 2026

E-cigarette Use for Smokers with Mental Illness

Recruiting in Palo Alto (17 mi)
HM
Overseen byHaruka Minami, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Fordham University
No Placebo Group

Trial Summary

What is the purpose of this trial?

This study aims to establish the feasibility and acceptability of a project designed to investigate the impact of electronic cigarette use on combustible cigarette smoking and smoking-related factors among smokers with psychiatric disorders, a high-risk population, who are not yet ready to quit smoking. All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8 weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.

Research Team

HM

Haruka Minami, Ph.D.

Principal Investigator

Fordham University

Eligibility Criteria

This trial is for English-speaking adults over 21 with a psychiatric disorder who smoke at least 5 cigarettes daily and have been doing so for over 6 months. Participants should not be currently trying to quit smoking, using quitting aids, or have cognitive impairments that prevent informed consent. They must not be pregnant, breastfeeding, planning pregnancy soon, or have unstable heart or lung conditions.

Inclusion Criteria

You have been smoking every day for at least 6 months.
Attended a minimum of 2 treatment visits in the past 12 months at Montefiore Behavioral Health Center
I am willing to use birth control during the study.
See 6 more

Exclusion Criteria

You are currently experiencing severe mental health problems, including thoughts of hurting yourself.
I understand the study procedures after no more than two explanations.
Current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
See 9 more

Treatment Details

Interventions

  • E-cigarette (Other)
Trial OverviewThe study tests if smokers with psychiatric disorders can switch from regular cigarettes to e-cigarettes provided by the research team for 8 weeks. The impact on their smoking habits will be monitored at different intervals up to three months after starting.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: E-cigaretteExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fordham University

Lead Sponsor

Trials
21
Recruited
4,100+

Montefiore Medical Center

Collaborator

Trials
468
Recruited
599,000+
Andrew D. Racine profile image

Andrew D. Racine

Montefiore Medical Center

Chief Medical Officer since 1992

MD, PhD from New York University; Undergraduate degree from Harvard University

Philip O. Ozuah profile image

Philip O. Ozuah

Montefiore Medical Center

Chief Executive Officer since 2019

MD, PhD from New York University

Dartmouth College

Collaborator

Trials
93
Recruited
1,415,000+

Sian Leah Beilock

Dartmouth College

Chief Executive Officer since 2023

PhD in Cognitive Psychology and Neuroscience from Miami University

Estevan Garcia

Dartmouth College

Chief Medical Officer since 2024

MD from Stony Brook University School of Medicine