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The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products

NCT03492463 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-02-08

Study results available
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Summary

This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.

Conditions

  • Nicotine Dependence, Cigarettes

Interventions

DRUG

Nicotine patch

Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.

OTHER

Placebo patch

Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.

OTHER

E-cigarettes

Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.

OTHER

Non-nicotine e-cigarettes

Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Jed E. Rose, Ph.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03492463 on ClinicalTrials.gov