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Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

NCT02342795 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2018-09-07

No results posted yet for this study

Summary

The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.

Conditions

  • Nontherapeutic

Interventions

OTHER

e-cigarette

OTHER

cigarette substitute

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Penn State University

    collaborator OTHER

  • Food and Drug Administration (FDA)

    collaborator FED

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Thomas Eissenberg · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • United States

Study Locations

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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 NCT02342795 on ClinicalTrials.gov