E-cigarettes + NRT for Smoking Reduction in Mental Illness

N/A

Recruiting

Led By Omar El-Shahawy

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare e-cigarette and nicotine replacement therapy to reduce smoking among people with serious mental illness.

Who is the study for?

This trial is for adults over 21 with Serious Mental Illness who smoke cigarettes regularly and are interested in reducing smoking but not necessarily quitting. They must be able to consent, have a mobile phone, and not be pregnant or breastfeeding. Those using non-cigarette tobacco recently or with recent changes in psychotropic meds, substance abuse issues, or acute psychiatric crises cannot join.

What is being tested?

Participants will receive counseling and text message interventions aimed at harm reduction from smoking. They'll randomly get either e-cigarettes (EC) or nicotine replacement therapy (NRT), like patches or gums, to see which helps more in cutting down cigarette use among those with mental illness.

What are the potential side effects?

Potential side effects may include irritation from NRT products such as skin redness from patches or mouth issues from lozenges/gums. E-cigarettes can cause throat/mouth irritation, coughing, and possibly other unknown long-term effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4

Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8

Secondary study objectives

Change in American Thoracic Questionnaire Score from Baseline to Week 12

Change in Symptom Check Questionnaire Score from Baseline to Week 12

Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12

+2 more

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: E-cigarettes (EC)Experimental Treatment3 Interventions

Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.

Group II: Nicotine Replacement Therapy (NRT)Active Control3 Interventions

Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.

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