Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study
This interventional controlled study (n=20) will evaluate GPM-Complex psychotherapy with or without 2–5 MDMA-assisted sessions (initial 80 mg with optional 40 mg supplemental dose) for treating PTSD in individuals with co-occurring BPD.
Detailed Description
Participants undergo a six-week pre-treatment module of one-hour weekly individual GPM-Complex sessions for psychoeducation, treatment planning and, for the MDMA arm, preparatory sessions. MDMA sessions are oral, delivered in a dedicated space with two therapists (one psychiatrist prescriber and one DBT-experienced co-therapist) and last up to eight hours.
Between two and five MDMA sessions are offered over a six-month course; dosing is individualised with a standard starting dose of 80 mg plus an optional 40 mg supplemental dose. Post-MDMA integration sessions continue weekly as part of GPM-Complex and outcomes are assessed during treatment and at 3 and 6 months post-discharge.
Comparator participants receive the same GPM-Complex psychotherapy schedule without MDMA. The study focuses on clinical effectiveness and safety within a public mental health service setting.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA + GPM
experimentalGPM-Complex plus 2–5 MDMA-assisted sessions (individualised; 1-month minimum between sessions).
Interventions
- MDMA80 mgvia Oral• 2-5 sessions over 6 months• 5 doses total
Initial 80 mg with optional 40 mg supplemental dose; subsequent session dosing individualised per clinician judgement.
- Compoundvia Other• weekly
GPM-Complex psychotherapy: one-hour weekly pre-treatment module (6 weeks), preparatory sessions, and weekly post-MDMA integration sessions; sessions delivered by two therapists (one psychiatrist prescriber + co-therapist).
GPM only
active comparatorGPM-Complex psychotherapy without MDMA sessions; weekly one-hour sessions for six months.
Interventions
- Compoundvia Other• weekly
GPM-Complex psychotherapy: one-hour weekly for six months; matched to MDMA arm on sex, age, education and clinical presentation.
Participants
Inclusion Criteria
- Female clients aged 18 years or older who are eligible for treatment from Spectrum’s Complex Care Team (severe/high-risk presentations not suited to manualised specialised programs)
- Diagnosis of PTSD (or Complex PTSD)
- Diagnosis of borderline personality disorder (BPD)
- Effective method of contraception if of child-bearing potential
- Fluent in written and spoken English
Exclusion Criteria
- Diagnosis of Narcissistic or Antisocial Personality Disorder
- Diagnosis or likely diagnosis of Autism Spectrum Disorder or traits
- Currently taking prescription medication for ADHD
- Intellectual disability severe enough to affect informed consent or engagement in treatment
- Serious medical illness, particularly cardiovascular conditions
- Pregnant or breastfeeding
- Current medication prescribed to treat psychiatric symptoms that are contraindicated with MDMA (including certain antidepressants, MAOIs, anaesthetics, muscle relaxants, benzodiazepines, opioids, stimulants, ethanol); participants must cease contraindicated medications under clinical supervision with appropriate washout before MDMA dosing