En español
NIDA

Supplemental Information for NIDA e-cig

Revised November 2018

How to Order the Standardized Research E-Cigarette (SREC)

  1. Requests to purchase SREC should be made to Dr. Katerina Havranek, khavranek@njoy.com.
  2. The SREC can be purchased for use in NIH funded human subject studies that evaluate the use of electronic cigarettes to reduce exposure to more harmful tobacco products. Requests to purchase for any other use will be reviewed on an individual basis by NJOY, LLC. The SREC cannot be used in human studies investigating the treatment of nicotine addiction i.e., studies that have the ultimate of aim of eliminating all nicotine use.  FDA considers that such nicotine cessation studies would examine the SREC as a potential medical product. These studies would require Investigational New Drug (IND) approval and at the current time the SREC Product Master File does not meet IND requirement guidelines.

  3. When contacting NJOY, LLC regarding your request, you will need to provide the following information:
    1. Grantee contact information and order details using the following form: SREC Request Form (Word, 47KB)
    2. NIH Notice of Award
    3. Brief study protocol
  4. In order to use the SREC in human subject studies, an Investigational Tobacco Product (ITP) authorization must first be obtained from the FDA.  Guidance on how to file an ITP can be found here: https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm463953.pdf
    1. When filing the ITP application, you will need to include a Letter of Authorization (LOA) from NJOY, LLC.
    2. The LOA indicates that your application has NJOY’s permission to cross-reference the SREC Tobacco Product Master File, which is on file with The FDA Center for Tobacco Products.
    3. You should request the LOA when you contact NJOY, LLC, regarding your purchase of SREC.
    4. Submit the ITP application to:

      Center for Tobacco Products
      Food and Drug Administration
      Attn: Document Control Center
      10903 New Hampshire Avenue
      Building 71, Room 0335
      Silver Spring, MD 20993-002

For any additional information, contact either Dr. Kevin Walton, kevin.walton@nih.gov or Dr. Aidan Hampson, aidan.hampson@nih.gov.

Background

The SREC was developed to facilitate clinical e-cigarette research by developing a standardized device with a data package sufficient to support FDA authorization for clinical investigations. In addition, this project was designed to produce a device with consistent, well-characterized aerosol and demonstrated nicotine pharmacokinetics. More details can be found below. The SREC will be available to support multi-year clinical studies, and it is not anticipated that any modifications will be made to the device.

The SREC is not limited for use in NIDA funded studies, although the institute has issued a funding opportunity announcement, PAR-18-220, to promote its use in clinical studies. The SREC may be suitable for use in a wide-range of NIH funded projects.

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
  • Power - 9W
  • 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

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 - Webinar on SREC (PPT, 364 KB) or view as PDF, 197KB (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.

This page was last updated November 2018

Get this Publication

    Search for Funding

    2016-2020 NIDA Strategic Plan