Clinical TrialCompleted

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

Small observational pilot with repeated-measures within-subjects design (Front Pain Res 2023; Batievsky D, Weiner M, Kaplan SB, Thase ME; two clinical sites; PMID 37273242). Participants: N=10 adults with prior MDD and comorbid chronic pain; non-random allocation by treating clinicians. Psychedelic group (n=5): IM ketamine sessions, dose-escalating across 6 weekly sessions (40/50 mg session 1 up to 90/100 mg session 6), with integration therapy ~24 hours after each session using EMDR, mindfulness and self-regulation skills. Psycholytic group (n=5): oral/sublingual lozenge (25 mg sessions 1–2; 50 mg sessions 3–4; 75 mg sessions 5–6), with therapy concurrent with drug administration. Preparatory and integration psychotherapy provided. Outcomes: BDI, Brief Pain Inventory (BPI), GAD-7, PCL-5, MEQ30. Data collected via REDCap at T0 (baseline) and after sessions 1 (T-1), 3 (T-2), and 6 (T-3). CT.gov: 0 hits; PubMed DataBankList: empty; no registration identified.

Target Enrollment
10 participants
Study Type
interventional
Design
Non-randomized

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2021-01-01
    End: 2023-01-01

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