This unregistered trial (n=10) was an observational pilot study of ketamine-assisted psychotherapy for chronic pain and comorbid major depressive disorder in adults, which found that all participants experienced symptom reduction across depression, pain, anxiety, and PTSD measures.
This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.
The study evaluated two distinct ketamine-assisted psychotherapy (KAPT) approaches: a 'psychedelic' approach involving high-dose intramuscular ketamine administered 24 hours prior to integration therapy, and a 'psycholytic' approach using lower-dose sublingual lozenges administered during concurrent therapy sessions. The cohort consisted of ten adults presenting with comorbid chronic pain and major depressive disorder.
Researchers measured changes in depression (BDI), pain (BPI), anxiety (GAD-7), and PTSD (PCL-5) symptoms, alongside mystical experience (MEQ30). While the small sample size limited statistical power, all participants showed clinical improvement, with the high-dose psychedelic approach appearing to yield more consistent decreases in symptom severity.
High dose intramuscular ketamine injections followed by therapy sessions 24 hours later.
Dosages ranged from 40 to 100 mg. Regimen: session 1 (40 & 50mg), session 2 (50 & 60mg), session 3 (60 & 70mg), session 4 (70 & 80mg), session 5 (80 & 90mg), session 6 (90 & 100mg). 6 sessions over 6 weeks.
Low dose ketamine delivered sublingually via oral lozenges during therapy sessions.
Dosages ranged from 25 to 75 mg. Regimen: sessions 1 & 2 (25mg), sessions 3 & 4 (50mg), sessions 5 & 6 (75mg). 6 sessions over 6 weeks. Lozenges held/swished for 15 min.