Marijuana Research with Human Subjects
Conducting clinical research using marijuana involves interactions with three federal agencies. This includes: obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA) within the National Institutes of Health; review of an investigational new drug (IND) application and the research protocol by the Food and Drug Administration (FDA) and an investigator registration and site licensure by the Drug Enforcement Administration (DEA). Specifically:
- National Institute on Drug Abuse (NIDA) to obtain the marijuana for research. One important source of research-grade marijuana for scientific study is through the NIDA drug supply program. The marijuana supply program operates pursuant to the Single Convention on Narcotic Drugs, which imposes certain obligations related to governmental oversight of marijuana cultivation. In the United States, NIDA has been designated the agency responsible for overseeing the cultivation of marijuana for medicinal research. NIDA contracts with the University of Mississippi to grow marijuana for use in research studies. The University designates a secure plot of land where marijuana crops are grown, harvested, and stored. The marijuana is made into cigarettes or other purified elements of marijuana to use for research. Investigational marijuana products with varying strengths or potencies are available.
- Food and Drug Administration (FDA) to submit an investigational new drug (IND) application. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as marijuana, researchers need to work with the FDA and submit an IND application. The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. Specifically, the Guidance for Industry: Botanical Drug Products provides sponsors with guidance on submitting investigational INDs for botanical drug products.
- Drug Enforcement Administration (DEA) to obtain investigator registration and site licensure to conduct studies using marijuana. As a Schedule I controlled substance under the Controlled Substances Act (CSA), marijuana use in a clinical trial requires special licensure and registration requirements for the investigator and the site where the study will be conducted. For more information, see CFR §1301.18 DEA, Research Protocols.
Typical Process for Conducting Research with Marijuana
Step 1: Sponsor obtains pre-IND number from FDA.
|Step 2: Sponsor contacts NIDA to obtain information on the specific strains of marijuana available, so that information can be included in the IND application.|
Step 3: Sponsor contacts DEA for registration application and Schedule 1 license.
|Step 4: Sponsor receives Letter of Authorization (LOA) from NIDA.|
|Step 5: Sponsor sends copy of IND/protocol and LOA to FDA and DEA.|
Step 6: FDA reviews the IND.
|Step 7: Sponsor contacts NIDA to obtain the marijuana after the FDA completes its review of the IND, and the DEA registration is received.|
Development & Approval Process (Drugs) Conducting Clinical Trials, Types of Drug Applications, Forms and Submissions Requirements, Labeling Initiatives, Drug and Biologic Approval Reports
- FDA Center for Drug Evaluation and Research's Small Business and Industry Assistance group
- National Institutes of Health (NIH): Guidance on Procedures for Provision of Marijuana for Medical Research
- National Institute on Drug Abuse’s (NIDA) Role in Providing Marijuana for Research
Drug Enforcement Administraton
Title 21 Code of Federal Regulations
International Narcotics Control Board: Single Convention on Narcotic Drugs (1961) National Institute on Drug Abuse (NIDA): Ordering Guidelines for Marijuana and Marijuana Cigarettes