Ketamine Plus Exposure Therapy For Post-Traumatic Stress Disorder (PTSD)– Open Label Pilot Study Targeting Anxiety
This open-label Phase I/II trial (n=12) will study the effects of oral ketamine (beginning at 35 mg/70 kg and increasing to 140 mg/70 kg) in combination with prolonged exposure therapy for the treatment of post-traumatic stress disorder (PTSD).
Details
Open-label, single-group Phase I/II pilot (n=12) evaluating an intensive oral ketamine dosing schedule with weekly prolonged exposure therapy for PTSD. Dosing begins with an accelerated titration in week 1 followed by twice-weekly 2 mg/kg oral doses in weeks 2–11; all dosing occurs in clinic.
Prolonged Exposure psychotherapy is delivered one-on-one by a clinical psychologist once weekly (weeks 2–11), usually 24 hours after ketamine dosing; sessions last up to 2 hours. Safety and adherence are monitored at all clinic visits.
Primary population: adults 18–50 with PTSD and PSSI-5 >23 who have not responded to prior adequate medication and psychotherapy trials.