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Electronic Cigarette
E-Cigarettes + NRT and Counseling for Smoking in Opioid Use Disorder
Phase 2
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 month 6
Awards & highlights
Summary
This trial will compare e-cigarettes with NRT + counseling to help reduce smoking among people in opioid use disorder treatment. It will help provide a tool to reduce tobacco harm in a hard-to-treat population.
Who is the study for?
This trial is for adults over 21 with opioid use disorder who are in treatment programs, smoke at least 5 cigarettes per day, and want to reduce smoking but not necessarily quit. They must have a stable dose of methadone or buprenorphine and access to a mobile phone. It's not for those trying to quit smoking, with severe mental health issues, respiratory diseases, pregnant/breastfeeding women, or users of other tobacco products.
What is being tested?
The study tests if e-cigarettes combined with motivational counseling via telehealth can help reduce cigarette smoking more effectively than nicotine replacement therapy plus counseling in people undergoing opioid addiction treatment.
What are the potential side effects?
Potential side effects from using e-cigarettes may include throat irritation, coughing, dry mouth or increased nicotine dependence. Nicotine replacement products might cause skin irritation (patches), mouth issues (gum/lozenges), nausea or headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
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 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
Secondary study objectives
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Electronic CigaretteExperimental Treatment2 Interventions
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
Group II: Nicotine Replacement TherapyActive Control2 Interventions
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,789 Previous Clinical Trials
8,137,813 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,398 Previous Clinical Trials
861,300 Total Patients Enrolled
Omar El-ShahawyPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Nicotine Replacement Therapy
- Group 2: Electronic Cigarette
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