Effectiveness Of Psychedelic Therapy for Post Traumatic Stress Disorder (PTSD)

MDMA medicines are given orally in a capsule form once in the morning on the medicine days only. The medicine dosing is by the treating psychiatrist, and he will ensure the patient has swallowed the medicine at dosing. No other strategies are available or indicated. The medicines used are Methylenedioxy methamphetamine (MDMA) for PTSD. Medicine days occur 2-3 times (depending on response to treatment) interspersed with psychotherapy for treatment: ie 3 Preparatory sessions/1 Medicine Day/3 Integration Sessions 1 week apart/ 1 Medicine Day/ 3 Integration Sessions 1 week apart/ Then an optional 3rd Medicine Day and 3 Integration Sessions 1 week apart, if there's an inadequate response to treatment The usual dose of MDMA for arms 1 and 2, will be 120mg with 60mg top up 2 hours later as per the MAPS studies. The 80mg with 40mg top up will be if the higher dose option is not tolerated. If the patient is quite anxious we may dose the first medicine day at 80mg plus 40mg top up. Then move to 120mg plus 60mg top up for subsequent sessions. MDMA (80-120mg + 40-60mg top up) given once in morning on 2-3 medicine days only through the treatment interspersed with usual supportive psychotherapy (as detailed below). Psychotherapy (all sessions are 1 hour) • Three preparation sessions held approximately a week apart. Dr Ranil Gunewardene will conduct the first preparation session 1:1 in rooms or via Zoom for 60 minutes. During this session, further in depth assessment will take place and medical review. The second and third preparation session will be with a HREC approved Psychologist/ psychotherapist 1:1 either in rooms or via Zoom for 1 hour each. • One Dosing session ( approximately 6-7 hours face to face) where supportive, client centered psychotherapy is provided during the dosing experience at Northern Beaches Hospital Clinic Rooms. Psychiatrist Dr Ranil Gunewardene will conduct the administration of medicine, regular monitoring and medical supervision of the client. Dr Ranil Gunewardene will provide direct client time face to face as clinically required. The designated treating HREC approved Psychologist/ Psychotherapist will work face to face with the client throughout their dosing day providing client centered psychotherapy. • Three Integration sessions conducted 1:1 by HREC approved the psychologist/ psychotherapist with the first one held the day after the dosing session and then held approximately a week apart. Who: HREC approved Psychologists/Psychotherapists conducting the preparation sessions, dosing and integration therapy sessions are all fully registered and have additional training in psychedelic assisted therapy. Mode of Administration: Preparation and Integration sessions will be 1:1 with a psychologist/ psychotherapist or psychiatrist and will be offered either face to face or via Zoom for 60 minutes. Monitoring: • The treatment dyad consisting of Dr Ranil Gunewardene and one of the HREC approved PAT trained psychologists/psychotherapists will be consistent across the course of the treatment and will ensure follow up any non attendance at appointments with telephone contact from the clinic to support adherence to the full therapy program. • A spreadsheet that records client dates of sessions and disengagement from the therapy program prior to completion will be recorded along with action taken to re-engage the client. • Adverse Events will be recorded and reported to HREC and TGA • Pre and post psychometric measures will be administered. Psychedelic Assisted Psychotherapy for both MDMA and Psilocybin is taught during Psychedelic Assisted Therapy training programs that have been completed by all of the psychologists/psychotherapists and the psychiatrist delivering the service. In Summary the therapy approach for all sessions is simply supportive psychotherapy based. There is psychoeducation delivered and set setting and relationship building is undertaken. The therapist is encouraged to stay out of the way of the patient’s medicine guided realisations and perspective shifts. To be guided by the patient’s experiences not the therapist’s agenda. To encourage the rediscovering of the wiser self and to promote patient agency. The therapist is there to support the patient rediscovering and connecting to their “inner healing intelligence”. There are principles of emotional support, encouragement, validation of experiences and perspectives, exploration of feeling states, in a non directive and non judgmental therapist stance.