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E-cigarette
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,538 Total Patients Enrolled
Omar El-ShahawyPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to give my consent for treatment.I have been diagnosed with a serious mental illness like schizophrenia or bipolar disorder.I have not had thoughts of suicide or been hospitalized for psychiatric reasons in the last month.I am 21 years old or older.My mental health medication dose hasn't changed in the last month.I want to cut down on smoking but not necessarily quit.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotine Replacement Therapy (NRT)
- Group 2: E-cigarettes (EC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacant slots available for participants in this clinical research?
"The information collated on clinicaltrials.gov indicates that recruitment for this trial has not yet been resumed after the last edit was made on April 4th 2023. However, there are 421 other medical trials currently recruiting participants."
Answered by AI
What results are researchers hoping to glean from this exploration?
"This trial's primary aim is to determine the proportion of participants who have completely stopped smoking by Week 4. Secondary outcomes of this experiment include self-reported percent changes in CPD from baseline to Weeks 8 and 12, as well as a change in American Thoracic Questionnaire score (a Likert scale ranging from 1 to 5) at Week 12."
Answered by AI
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