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Behavioural Intervention

E-Cigarettes for Smokers With Mental Illness

N/A

Recruiting

Led By Sarah I. Pratt, PhD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Current diagnosis of Asthma

Current unstable medical illness that would make use of the e-cigarette unsafe (e.g., history of heart attack, cancer not in remission)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8 weeks, 8 weeks to 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if providing e-cigarettes with or without behavioral support through telehealth can help smokers who have had a heart attack but are not ready to quit smoking. They also want to see if

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include throat irritation, coughing, dry mouth, or nicotine dependence due to e-cigarette use.

Eligibility Criteria

Exclusion Criteria

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

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I have been diagnosed with asthma.

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I do not have any unstable illnesses like recent heart attacks or active cancer.

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I do not use any smoked products except for cigarettes or mini cigars.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8 weeks, 8 weeks to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 8 weeks, 8 weeks to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks, 8 weeks to 26 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

Change in CO level

Change in Urine NNAL

Change in self-reported cigarette use

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 3Eligibility criteria met