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Supplemental Information for NIDA e-cig

Revised March 2017

The two-year project duration period is intended to support studies that can be rapidly completed and published, with the intention of quickly providing independent research data sets on the SREC performance to the research community. Currently available technical details on the research e-cigarette can be found in the FOA.

To help investigators better understand the aims and intended limits on the range of studies to be supported under this FOA, NIDA held a webinar on Friday March 3, 2017.  The webinar contained a short presentation followed by a question and answer period to address questions from investigators.

To view the presentation:   Download - NIDA Webinar on E-cig FOA (PPT, 319 KB) or view as PDF, 169KB (508 compliant version)

Researchers with additional questions can directly email the NIDA Program contacts for the FOA: Dr. Kevin Walton, kevin.walton@nih.gov or Dr. Aidan Hampson, aidan.hampson@nih.gov.  We look forward to submission of your grant applications.

NIDA Standardized Research E-Cigarette (SREC)

Physical characteristics

  • Appearance of device and Liquid tank
     
    Standard e-cigarette
  • Dimensions of assembled device - 180 mm (L) x 14 mm (D)
  • Weight with fresh tank - 43.3 g

Cost of the device

  • Battery, USB cable, wall plug - $10 USD per set
  • Refill Tank - $10 USD

Tank characteristics

  • Sealed and disposable
  • Minimum number (3 s) puffs per tank - 350
  • Volume of e-liquid per tank - 3 mL

Rechargeable battery characteristics

  • Number puffs (3s) per charge - > 400 puffs
  • Battery lifetime (>80% initial capacity) - 300 charge cycles
  • Time to full charge via line power - ~ 90 min
  • Output voltage -  3.30 ± 0.05 V
  • Battery storage capacity - 1000 mAh

Description of device actuation method

  • Device unlock / lock mechanism - 5 button presses
  • Breath actuation draw force - ~ 0.8 L / min
  • LED flash confirms Lock/unlock

E-liquid Characteristics

  • Nicotine-containing and placebo versions are “tobacco” flavored
  • Shelf-life at 25C - > 1 year (unopened)
  • Nicotine concentration - 15 mg / mL
  • Propylene Glycol % - ~ 50% (wt / wt)
  • Glycerin % - ~ 50% (wt / wt)
  • Nicotine concentration - 15 mg / mL
  • 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 

Aerosol Characteristics (per puff)

  • Assay puff length - 3 s
  • Assay puff volume - 60 mL
  • Total particulate matter - ~ 7.4 mg
  • % particles between 0.32-1.8um - ~ 90 %
  • Propylene Glycol - 3.5 mg
  • Glycerin - 3.8 mg
  • Nicotine - 100 μg
  • Formaldehyde - 0.1 μg
  • Acetaldehyde - < 0.1 μg
  • Acrolein - < 0.1 μg

Summary of pharmacokinetic study results

Nicotine exposure was assessed in subjects with commercial unmodified e-cigarettes containing 10-20 mg / mL nicotine (“own device”) on Day 1. Studies were repeated with SREC on Day 3.

Subjects abstained from nicotine overnight then completed a 10‑inhalation session over 4.5 minutes followed by 2h abstinence with regular PK blood draws.

  Own device SREC
Tmax (min) Cmax (ng/ml) Tmax (min) Cmax (ng/ml)
Median 8.5 7.35 5.0 13.14
Min 3.0 2.18 5.0 3.98
Max 30.0 29.33 7.0 72.18

This page was last updated March 2017

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