Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder

Any ongoing concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.

Ongoing treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) or opiates (e.g., codeine, morphine) as assessed by clinical interview and urine toxicology testing.

Ongoing treatment with any medication that has a clinically significant drug-drug interaction with either telmisartan or verapamil, per the verapamil SR and telmisartan FDA labels and per standard drug interaction compendia. These include but are not limited to: Inhibitors or inducers of cytochrome P450 (CYP)3A4 (including certain β-hydroxy β-methylglutaryl-CoA [HMG-CoA] reductase inhibitors), Ivabradine, Antihypertensive Agents (including Beta Blockers), Antiarrhythmic Agents, Lithium, Carbamazepine, Rifampin, Phenobarbital, cyclosporin, theophylline, Inhalation Anesthetics, Neuromuscular Blocking Agents, Telithromycin, mTOR inhibitors as well as strong P-glycoprotein inhibitors (e.g., macrolides, ritonavir, itraconazole, ketoconazole, cyclosporin, ritonavir, and ivermectin).

Diagnosis of Severe Substance Use Disorder, Obsessive-Compulsive Disorder (OCD), Bipolar I, Bipolar II disorder, or Psychotic disorder (per SCID-V) or Borderline Personality Disorder (per Short-Bord).