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E-cigarette Use for Smokers with Mental Illness

N/A

Recruiting

Led By Haruka Minami, Ph.D.

Research Sponsored by Fordham University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21 years of age or older

Be older than 18 years old

Must not have

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 unstable cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how effective e-cigarettes are for smokers with psychiatric disorders who are not ready to quit smoking.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed in this summary, e-cigarette use may include throat/mouth irritation, coughing, nausea, headache or increased nicotine dependence. Side effects vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand the study procedures after no more than two explanations.

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I have a heart condition that is not stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Carbon Monoxide Level

Changes in Nicotine Dependence

Changes in the number of combustible cigarettes smoked per day

+2 more

Secondary study objectives

Changes in Motivation/Readiness to Quit Smoking

Changes in Withdrawal Symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met