NCT03473483

Cigarette Harm Reduction With Electronic Cigarette Use

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Daily cigarette smokers who are familiar with e-cigarette (EC) use will be instructed to use only NIDA Standardized Research Electronic Cigarettes (SREC) and tobacco cigarettes (TC) while enrolled on the study. Our overall goals are two-fold: (1) to compare nicotine and toxicant exposure and pharmacological effects of SREC used alone vs tobacco cigarettes alone (TC), or dual use; and (2) using SREC alone, TC alone, or ad libitum SREC use combined with 50% reduction in usual TC use as a model for dual use, to examine the extent to which nicotine and toxicant exposure and biomarkers of potential harm compare among the 3 groups. The former would inform the effects of total switching, the latter would inform the potential harm reducing effects of smoking fewer TC while using EC.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2018-03-22
• Last updated: 2022-12-09

Locations

1 site across 1 country: United States