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Electronic Cigarette

E-Cigarettes + NRT and Counseling for Smoking in Opioid Use Disorder

Phase 2
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

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 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
Secondary outcome measures
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)
+6 more

Trial 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).

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,229 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,371 Total Patients Enrolled
Omar El-ShahawyPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Opioid Use Disorder Research Study Groups: Nicotine Replacement Therapy, Electronic Cigarette

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals over the age of forty eligible to partake in this medical experiment?

"This clinical trial features an age requirement, with the youngest patient being 21 years old and the oldest 75."

Answered by AI

Has the FDA given its stamp of approval to Electronic Cigarettes?

"The safety of Electronic Cigarettes was judged to be a 2 since the trial is in Phase 2, which only has evidence backing its relative security, not efficacy."

Answered by AI

Are any fresh participants being considered for this trial?

"This trial, which was initially posted on March 1st of 2023 and had its last update on February 9th of the same year, is not presently looking for volunteers. However, there are 576 other clinical trials actively engaging patients at this time."

Answered by AI

Are there any restrictions on who can take part in this clinical experiment?

"This clinical trial is currently recruiting 350 participants who are between 21 to 75 years-old and have a smoking/cigarette habit of at least 5 cigarettes per day (CPD). The criteria for admission include: current CPD ≥5, age≥21, diagnosis with opioid use disorder (OUD), 12+ weeks in OUD treatment program (Methadone or Buprenorphine) via self-report or EHR records, two week stable Methadone or Buprenorphine dose as confirmed by self report or EHR records, willing to reduce combustible cigarette consumption but not necessarily quit altogether; mobile phone"

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
2024. "E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722561.
All > Smoking
~233 spots leftby Nov 2026
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