Request for Information (RFI): Inviting Comments on the Establishment and Implementation of a Standard Unit Dose of Δ-9-tetrahydrocannabinol (THC) for Cannabis Research

Notice Number: NOT-DA-20-043

Key Dates
Release Date: March 23, 2020
Response Date: May 01, 2020

Related Announcements
None

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Request for Information (RFI) is to invite input on the establishment and implementation of a standard unit dose of THC for cannabis research.

Note: It is important to read this entire RFI notice to ensure how to submit adequate responses and to understand how the responses will be utilized.

Background:

As the diversity of products, potency, and use of cannabis increase, research grows ever more critical to determine both the adverse health effects and therapeutic potential of cannabis and its constituents. The potency of such products has increased rapidly: the THC concentration in commonly cultivated marijuana plants increased four-fold between 1995 and 2018 (From 4 to 16); marijuana available in dispensaries in some states has average concentrations of THC between 17.7 percent and 23.2 percent. The consequences of this change in potency are not yet well understood.

In their Recommendations for NIDA’s Cannabis Policy Research Agenda, theCannabis Policy Research Workgroup of the National Advisory Council on Drug Abuse recommended that NIDA “explore the possibility of constructing a standardized dose similar to that for alcohol (the standard drink), tobacco (a cigarette), or opioids (morphine milligram equivalents) for researchers to employ in analyzing use and for users to understand their consumption.” In February 2020, NIDA Director Nora Volkow published a commentary highlighting the importance of a standard unit dose for cannabis research. While establishment of a standard unit dose for cannabis is complicated by variability due to different routes of administration, different constituents in the product, as well as other factors including the behavior of the users, such a unit is critical for conducting rigorous cannabis research. Recognizing that a perfect measure may not be attainable at the current time, NIDA still believes that a standard dose would improve measures of outcomes in relation to exposure; and thus, could inform policy and public health strategies around cannabis use.

Information Requested:

This RFI seeks input from stakeholders throughout the scientific research community and any other interested parties regarding the establishment of a standard unit dose of THC for cannabis research.

The NIH seeks comments on any of the following topics:

  • 5mg as a standard THC dose irrespective of route of consumption
  • Challenges and benefits to conducting research using a standard unit dose of THC including:
    • Comparability across studies, including accurate data collection and publication of methods and results
    • Comparability with legacy datasets and surveillance measures (e.g., MTF, NSDUH, YRBS)
    • Benefits and limitations of a standard unit dose that does not depend on route of administration and/or other cannabinoid constituents
    • Implementation in human laboratory and/or clinical studies
    • Implementation in observational and/or epidemiological studies
      • Labeling requirements for cannabis products
      • Education of users to acquire accurate data
  • Any other topic the respondent feels is relevant for NIDA to consider in establishing a standard unit dose of THC.

How to Submit a Response:

Responses to this RFI must be submitted electronically via:THCdoseRFI@nih.gov

Responses must be received by May 1, 2020.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response.The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise because of a response to this request for information or from the Government’s use of such information. NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Ruben Baler
National Institute on Drug Abuse (NIDA)
Email: baler@nida.nih.gov