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 35mg/70kg and increasing to 140mg/70kg) in combination with prolonged exposure therapy for the treatment of post-traumatic stress disorder (PTSD).

PTSD is a chronic and often treatment-resistant mental health condition marked by intrusive memories, hyperarousal, and emotional avoidance following exposure to traumatic events. Many individuals with PTSD struggle to engage in trauma-focused therapy due to intense anxiety and fear. In this trial, researchers at the University of Otago in New Zealand aim to explore whether oral ketamine—a fast-acting anaesthetic known for its antidepressant and anti-anxiety effects—can help reduce these symptoms early in treatment and improve engagement with psychotherapy. Participants will first receive a week of escalating ketamine doses (0.5 mg/kg to 2 mg/kg), followed by 10 weeks of twice-weekly dosing at 2 mg/kg. Each dose will be mixed with orange juice and consumed over 30 minutes in a clinical setting.

Beginning in the second week, participants will also attend weekly one-on-one prolonged exposure therapy sessions with a clinical psychologist. This therapy involves repeated and systematic exposure to trauma-related memories and cues to help reduce avoidance and emotional distress. The researchers hypothesise that ketamine will ease patients into the therapeutic process and potentially enhance outcomes.

The study’s primary outcomes include anxiety symptoms measured with the Posttraumatic Stress Disorder Symptom Scale (PSSI-5), and suicidality assessed by the Columbia-Suicide Severity Rating Scale (CSSRS). Secondary measures include bladder-related symptoms and adverse effects such as sedation or dizziness. The trial is funded by the James Hume Fund and led by Professor Paul Glue. Data gathered from this pilot will inform the design of a larger, controlled trial.

Topic PTSD Anxiety Suicidality Safety
Compound Ketamine
Country New Zealand
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University of Otago
The University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.

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