Veteran Treatment Research

Veterans Medical Cannabis Research Registration

Battle Brothers Foundation - 642-20-01, An Observational Study Evaluating the Safety and Efficacy of Medical Cannabis in Posttraumatic Stress Disorder (PTSD) Management. (Pro00044071)

Coming Soon*

What Is an Institutional Review Board (IRB)?

An IRB is a committee within a university or other organization to conduct research that reviews research proposals. The IRB reviews the proposals before a project is submitted to determine if the research project follows the ethical principles and Federal Regulations for the protection of human subjects. It ensures that only ethical and scientifically valid research is implemented. The IRB has the authority to approve, disapprove or require modifications of these projects.

Key Inclusion Criteria:

  • Participants who purchased medical cannabis individually, under their own discretion, using their own funds.
  • Validated and documented diagnosis of chronic PTSD of at least six months duration and of at least moderate severity as measured by a score of > 40 on the PTSD Checklist for DSM-5 (PCL-5) at the time of baseline assessment.
  • The PTSD is defined treatment resistant if patient had failing on, or being unable to tolerate FDA-approved medications or empirically supported psychotherapies for PTSD or adequate dose and duration, as determined on a case-by-case basis by the site investigators.
  • Patients with capacity to sign written informed consent.

Key Exclusion Criteria:

  • Active malignancy or malignancy in the past 12 months.
  • History of substance abuse.
  • History of primary psychotic disorder, bipolar affective disorder, bipolar disorder with psychotic features, borderline personality disorder, antisocial personality disorder, or positive family history (first degree relative) or psychotic disorder or bipolar affective disorder.
  • Pregnancy/breast feeding.
  • Recent (past 6 months) myocardial infarction.
  • Life expectancy of less than 12 months.

More to follow ...

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