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NCT02342795 · ClinicalTrials.gov registry record · Phase 1

Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

A Phase 1 study of Nontherapeutic, sponsored by Virginia Commonwealth University.

Completed
Registry status
Phase 1
Development phase
520
Enrollment target
2
Study locations

NCT02342795: Completed Phase 1 study of Nontherapeutic, sponsored by Virginia Commonwealth University.

NCT02342795 is a Phase 1 study of Nontherapeutic that has completed, run by Virginia Commonwealth University. The registered enrollment target is 520 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (767% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02342795, a Phase 1 study of Nontherapeutic, has completed, sponsored by Virginia Commonwealth University.

COMPLETED
Registry status
Phase 1
Development phase
520 participants
Enrollment target
2
Study locations

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.

Primary Outcome

changes in NNAL concentration measured at week 0, week 4, week 12, and week 24

Conditions Studied

Interventions

  • OTHER e-cigarette
  • OTHER cigarette substitute

Study Locations (2)

Pennsylvania

  • Penn State Milton S. Hershey Medical Center - Hershey

Virginia

  • Center for the Study of Tobacco Products - Richmond

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2015-06
Est. Completion 2018-07
Phase Phase 1
Virginia Commonwealth University

558 total trials

What the finished NCT02342795 record still lists

NCT02342795 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (767% higher).

The record links to 1 condition, with Nontherapeutic appearing as the primary indexed condition, and to 2 interventions - of which e-cigarette is the first listed.

NCT02342795 reports a single indexed study location in Pennsylvania, Virginia.

Frequently Asked Questions

What is clinical trial NCT02342795 about?

NCT02342795 is a clinical study titled "Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation". 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...

What is the current status of trial NCT02342795?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 520 participants. The study started on 2015-06. Estimated completion is 2018-07.

What conditions does trial NCT02342795 study?

This clinical trial studies the following conditions: Nontherapeutic.

What interventions are being tested in trial NCT02342795?

The interventions under investigation include: e-cigarette (OTHER), cigarette substitute (OTHER).

Who is sponsoring clinical trial NCT02342795?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02342795 being conducted?

This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02342795's enrollment target sits among peer trials

520 40th of 2000 higher than 1,961 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02342795, the US trial registry maintained by the National Library of Medicine. NCT02342795 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.