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).
Detailed Description
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.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Oral ketamine + PE
experimentalOral ketamine dosing course combined with weekly prolonged exposure therapy (single-group, open-label).
Interventions
- Ketamine2 mg/kgvia Oral• intensive week1 then twice weekly• 27 doses total
Week 1: Day1 0.5 mg/kg, Day2 1.0 mg/kg, Day3 1.5 mg/kg, Days4–7 2.0 mg/kg. Weeks 2–11: 2.0 mg/kg twice weekly. All doses mixed in 100 mL orange juice and sipped over 30 minutes at Fraser Building clinic.
- Compoundvia Other• weekly
Prolonged Exposure psychotherapy sessions once weekly (weeks 2–11), typically 24 h after dosing; 1:1 with clinical psychologist; sessions up to 2 hours.
Participants
Inclusion Criteria
- Male or female aged between 18 and 50 years
- Capable of understanding and signing an informed consent
- Diagnosed with post-traumatic stress disorder (PTSD) with a PSSI-5 score >23
- Inadequate response to prior treatment: not responded to at least two adequate trials of relevant medication and at least one trial of relevant psychotherapy
Exclusion Criteria
- Evidence of severe acute or chronic medical disorders
- Past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms
- Current diagnosis of severe personality disorder
- Female patients who are pregnant or lactating
- Drug abuse or dependence in the last 6 months
- Current significant suicidal ideation
- Participants must be free of recreational drug and alcohol use at the time of testing