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
Study Protocol, Arms & Participants
Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.
Locations
Your Personal Research Library
Go Pro to save trials, add notes, rate research, and organize custom shelves.