Clinical TrialParallelChronic PainKetamineKetamineCompleted

Ketamine-Assisted Psychotherapy for Chronic Pain and Comorbid Depression: Pilot Study (Batievsky 2023, Front Pain Res)

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.

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Target Enrollment
10 participants
Study Type
interventional
Design
Non-randomized

Detailed Description

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.

Study Arms & Interventions

Psychedelic approach

experimental

High dose intramuscular ketamine injections followed by therapy sessions 24 hours later.

Interventions

  • Ketamine70 mg
    via IM• twice weekly• 12 doses total

    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.

Psycholytic approach

experimental

Low dose ketamine delivered sublingually via oral lozenges during therapy sessions.

Interventions

  • Ketamine50 mg
    via Sublingual• weekly• 6 doses total

    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.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2021-01-01
    End: 2023-01-01
  • Compounds
    KetamineKetamine
  • Topic
    Chronic Pain

Related Publications

Open AccessindividualPrimary

Ketamine-assisted psychotherapy treatment of chronic pain and comorbid depression: a pilot study of two approaches

This observational pilot of ten people with chronic pain and comorbid major depressive disorder compared a high‑dose intramuscular "psychedelic" KAPT protocol with a low‑dose sublingual "psycholytic" protocol and found reductions in depression, pain, anxiety and PTSD symptoms overall, with larger and more consistent decreases in the psychedelic group though differences were not statistically significant given the small sample. The authors conclude KAPT may be beneficial for chronic pain/MDD comorbidity and recommend larger controlled trials to determine optimal dosing and administration.

Published
Journal
Frontiers in Pain Research
Authors
Batievsky, D., Weiner, M., Kaplan, S. B., Thase, M., Maglione, D. N., Vidot, D. C.