Phase 2 Multicenter Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of Inhaled Cannabis in Veterans for Treatment of Posttraumatic Stress Disorder (PTSD)

Exclusion criteria

• 1. Are pregnant, nursing, or are a person able to become pregnant who are not practicing an effective means of birth control. 2. Have current major depressive disorder with primary psychotic features 3. Have current or past DSM-5 diagnosis of eating disorder with active purging, personality disorders, primary psychotic disorder, or bipolar affective disorder type 1 4. Have current or past DSM-5 diagnosis of dissociative identity disorder, positive family history (first degree relative) of psychotic disorder or bipolar affective disorder type 1 5. Are at high risk of suicide attempt: any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. 6. Would present serious risk to others as established by clinical interview and contact with treating psychiatrist. 7. Have a current moderate or severe alcohol or cannabis use disorder within the 12 months prior to enrollment. Participants with a substance use disorder other than alcohol or cannabis are excluded. 8. Have a positive urine drug screen for opiates, methamphetamine, cocaine, THC, and amphetamines (unless prescribed). Participants with a positive THC urine analysis test are excluded from the study, but will be allowed to rescreen once after a 1-month cessation of cannabis use 9. Have a history of arrhythmia, other than occasional premature atrial contractions (PACs) and PVCs in the absence of ischemic heart disease, within 12 months of screening.
• Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist. 10. Have a current or history of chronic obstructive pulmonary disease or asthma. 11. Have a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, hepatic, immunocompromising, or neurological disease according to CI's discretion. 12. Have any current problem or presence of clinical feature which, in the opinion of the CI or Medical Monitor, might interfere with or prevent appropriate study participation. 13. Have any known allergies to cannabis or contraindication for inhalation of cannabis. 14. Are not able to give adequate informed consent. 15. Insufficient ability to report on symptoms to make a valid assessment on any required instrument. 16. Are not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.