None listed
Conditions
Brief summary
This is an open-label feasibility study to assess the acceptability of using combined oral ketamine (K) and prolonger exposure (PE) psychotherapy in patients with Post-Traumatic Stress Disorder. We hypothesize that treatment with oral ketamine in week 1 will reduce distress and fear in most participants, and make participation in PE during weeks 2-11 much easier. We anticipate that some patients completing K+PE will have complete resolution of their PTSD symptoms.
Interventions
1: Oral ketamine: Week 1: Day 1 – 0.5mg/kg; day 2: 1mg/kg; day 3: 1.5mg/kg; days 4-7: 2mg/kg.
Weeks 2-11: Oral ketamine 2mg/kg twice weekly. All dosing will occur in the Fraser Building clinic.
All ketamine doses to be mixed with 100mL of orange juice which will be sipped over 30 minutes.
2: Psychotherapy: Prolonged Exposure sessions, once each week, weeks 2-11, usually 24h after oral ketamine dosing. Sessions last up to 2 hours. All sessions are 1-on-1 with a clinical psychologist. During the
1: Oral ketamine: Week 1: Day 1 – 0.5mg/kg; day 2: 1mg/kg; day 3: 1.5mg/kg; days 4-7: 2mg/kg. Weeks 2-11: Oral ketamine 2mg/kg twice weekly. All dosing will occur in the Fraser Building clinic. All ketamine doses to be mixed with 100mL of orange juice which will be sipped over 30 minutes. 2: Psychotherapy: Prolonged Exposure sessions, once each week, weeks 2-11, usually 24h after oral ketamine dosing. Sessions last up to 2 hours. All sessions are 1-on-1 with a clinical psychologist. During the sessions, patients will be gradually and repeatedly exposed to trauma-related memories, feelings, and situations that they have been avoiding. All sessions will occur in the Fraser Building clinic. We will monitor adherence for all clinic visits.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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. • Patients must have had an inadequate response to prior treatment i.e. have 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
Outcome results
None listed