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Research programs
CBDYNE is pursuing separate laboratory research programs involving CBD and kratom-derived material. These programs are investigational and should not be interpreted as established treatments.
Our research interests include PTSD-related questions and opioid-use-disorder-related questions, including populations where trauma and opioid dependence may co-occur. Details of the investigational compound, formulation, protocol, study population and endpoints are not yet published.
Target: human clinical trials to begin in Q2 2027.
We are pursuing a separate CBD research program in relation to PTSD. This is a research objective, not a claim that CBD has been demonstrated to prevent, treat or cure PTSD.
We do not represent any CBDYNE investigational product as FDA-approved, clinically proven, or available for the treatment of PTSD, opioid use disorder or any other disease.
An Investigational New Drug (IND) application is a regulatory submission to the U.S. Food and Drug Administration seeking to conduct clinical investigations of an investigational drug. It is not a marketing approval and does not establish that the product is safe or effective.
Before a proposed clinical study may proceed under an IND, the sponsor must provide information that may include nonclinical pharmacology and toxicology, manufacturing and quality information, and clinical study protocols. FDA may impose a clinical hold if it identifies concerns that must be resolved.
PTSD associated with veteran trauma, PTSD in people who also have opioid use disorder, and treatment outcomes for opioid use disorder are related but distinct research questions. They may require different eligibility criteria, study designs, safety monitoring and clinical endpoints. The initial IND scope and protocol are not yet published.
Where we are today: we have not yet submitted an IND, received an IND effective date, or begun human trials.
FDA’s public information notes that no kratom or kratom-alkaloid drug product is FDA-approved and describes important safety and evidence gaps. NIH has separately reported an IND becoming effective for a purified mitragynine program aimed at opioid use disorder; that program is not evidence of PTSD efficacy and is not a CBDYNE program.
For background, see the FDA’s information on kratom (opens in a new tab) and the NIH news release archive (opens in a new tab). External links are provided for general context, not as endorsements or evidence of a relationship with CBDYNE.
For research-related inquiries, use our inquiry form and choose “Research collaboration”.
