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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 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 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 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: 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).

Do I qualify?Apply below to find out