MedTrace Logo

Cigarette Harm Reduction With Electronic Cigarette Use

NCT03473483 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-09

No results posted yet for this study

Summary

This is an observational, crossover study that will be examine use behaviors, chemical exposures, and biological effects of SREC compared to TC use in subjects confined to a research ward setting.

Conditions

  • Nicotine Dependence
  • Tobacco Toxicity
  • Nicotine Dependence, Cigarettes
  • Cardiovascular Risk Factor
  • Nicotine Withdrawal

Interventions

OTHER

SREC

The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Tank: * Sealed and disposable * Minimum 350 puffs per tank * Volume of e-liquid per tank \~ 3ml E-Liquid Characteristics: * Tobacco flavored * Nicotine concentration: 15 mg/ml * Propylene Glycol:\~ 50% (wt / wt) * Glycerin: \~ 50% (wt / wt) * Cotinine: \<1 μg/g * Nornicotine: 5 μg/g * Myosmine : 3 μg/g * Anabasine: \<1 μg/g * Anatabine: \<1 μg/g * Beta:nicotyrine: \<1 μg/g * Diacetyl: \<2 μg/g * 2,3:Pentanedione: \<1 μg/g * Arsenic: \<0.1 μg/g * Cadmium: \<0.1 μg/g * Chromium: \<0.1 μg/g * Lead: \<0.1 μg/g * Nickel: \<0.1 μg/g * Mercury: \<0.05 μg/g

Sponsors & Collaborators

Principal Investigators

  • Neal L. Benowitz, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT03473483 on ClinicalTrials.gov