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E-Cigarettes for Smoking in Substance Use Disorders
Phase 2
Recruiting
Led By Scott Sherman, MD
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
Must not have
report having a history of asthma, other airways diseases, or heart disease.
currently using smoking cessation medications (including other forms of NRT, buproprion, or varenicline)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Summary
This trial will test whether e-cigarettes can help patients in addiction treatment quit smoking cigarettes, as they have higher rates of smoking than the general population.
Who is the study for?
This trial is for individuals who smoke at least 10 cigarettes daily, are in addiction treatment, and have had alcohol or opioid use disorder in the past year. Participants must be able to consent, interested in reducing smoking, use a cellphone for daily texts about their smoking and e-cigarette use but not currently using other tobacco products or cessation aids.Check my eligibility
What is being tested?
The study explores if e-cigarettes can help people with substance use disorders reduce harm from smoking. It involves giving participants either real or placebo e-cigarettes and monitoring their cigarette consumption over three weeks to see if there's any change.See study design
What are the potential side effects?
Potential side effects of nicotine replacement therapy like e-cigarettes may include throat irritation, coughing, headache, nausea, and dependency on the product. The exact side effects will depend on individual reactions to using e-cigarettes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of asthma, airway diseases, or heart disease.
Select...
I am currently using medication to help me stop smoking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who achieve 50% reduction in CPD at 3 weeks.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: E cigarettesExperimental Treatment1 Intervention
Group II: Nicotine Replacement TherapyActive Control1 Intervention
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,878 Total Patients Enrolled
Scott Sherman, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
1,089 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently participating in a program to quit smoking or another study related to quitting smoking.I have a history of asthma, airway diseases, or heart disease.You smoke at least 10 cigarettes every day.You are able to receive and send text messages on your cell phone and are willing to report your cigarette and e-cigarette use on a daily basis through text messages.You have used an e-cigarette within the last two weeks.You have been diagnosed with alcohol or opioid use disorder within the past year and are willing to reduce your cigarette smoking.I am currently using medication to help me stop smoking.I can provide an extra contact and am willing to use an e-cigarette for 3 weeks.You have used any form of tobacco, including smoking pipes, cigars, chewing tobacco, and hookah, within the past 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: E cigarettes
- Group 2: Nicotine Replacement Therapy
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.
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