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Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD

NCT04465318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-06-15

No results posted yet for this study

Summary

The study team proposes a two-arm pilot study randomizing participants with COPD who smoke combustible cigarettes (CC) to counseling + NRT (standard of care) or counseling + e-cigarettes.

Conditions

Interventions

OTHER

E-cigarette (EC)

NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.

OTHER

Nicotine Replacement Therapy (NRT)

Participants in the NRT arm will receive 21 mg nicotine patch (for those with CPD \>= 20) or 14 mg nicotine patch (for those with CPD \< 20) + 4 mg nicotine gum. CPD stands for Cigarettes Per Day.

BEHAVIORAL

Smoking Harm Reduction Counseling Sessions

Counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects know to contribute to smoking among people with COPD (e.g., tips on dealing with depression)

Sponsors & Collaborators

Principal Investigators

  • Scott E. Sherman, MD, MPH · NYU Langone Health

  • Elizabeth Stevens, PhD, MPH · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2023-03-08
Completion
2023-03-09

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465318 on ClinicalTrials.gov