Our investigational kratom program.

Research focus

Our research interests include PTSD-related questions and opioid-use-disorder-related questions, including populations where trauma and opioid dependence may co-occur.

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.

Details of the investigational compound, formulation, protocol, study population and endpoints are not yet published.

Target

We are targeting the start of human clinical trials in Q2 2027. In the United States, human clinical trials of an investigational drug proceed under an Investigational New Drug (IND) application to the FDA. A trial start is not FDA approval and does not establish that the product is safe or effective.

What an IND means

What is not yet established

• That kratom or any specific kratom alkaloid is an effective treatment for PTSD.
• The identity, composition, dose, route of administration or clinical formulation of the investigational product.
• The existence of a particular FDA-approved indication or marketing authorization.

Where we are today: we have not yet submitted an IND, received an IND effective date, or begun human trials.

Scientific and regulatory context

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.