Australian 3,4-Methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy Study for the Treatment of Posttraumatic Stress Disorder (PTSD)
An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians
Edith Cowan University
4 participants
May 19, 2022
Interventional
Conditions
Summary
The objective of this investigator-initiated study is to determine whether an Australian treatment team can safely and effectively deliver 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with treatment-refractory posttraumatic stress disorder (PTSD) through training and ongoing mentoring from the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a non-profit research and educational organisation working to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy in patients with posttraumatic stress disorder (PTSD). It uses an open-label design to assess the feasibility of safely and effectively providing MDMA-assisted psychotherapy in Australia by treating four Western Australian adults with chronic treatment-resistant PTSD.
Eligibility
Inclusion Criteria8
- A diagnosis of current PTSD for more than 6 months.
- Have PTSD symptoms in the last month based on PCL-5 total score of 35 or greater.
- Are fluent in speaking and reading the predominantly used or recognised language of the study site.
- Are able to swallow pills.
- Agree to the study visits being video recorded, including MDMA Sessions, Independent Rater assessments and non-drug psychotherapy sessions.
- If of childbearing potential, must have a negative pregnancy test at study entry and prior to each MDMA Session, and must agree to use adequate birth control through 10 days after the last MDMA Session. Not of childbearing potential is defined as permanent sterilisation, postmenopausal, or assigned male at birth.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to MDMA Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each MDMA Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
- Have attempted to engage in at least one evidence-based psychotherapy for PTSD and trialled one medication.
Exclusion Criteria23
- Is unable to give adequate informed consent.
- Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
- Are likely, in the investigator’s opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation.
- Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first MDMA Session; or have previously participated in a MAPS-funded MDMA clinical trial.
- Have any current problem which, in the opinion of the investigator or Medical Monitors, might interfere with participation.
- Are prescribed a psychotropic medication that could adversely interact with MDMA.
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrolment.
- Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1 assessed via MINI or dissociative identity disorder.
- Have a current eating disorder with active purging.
- Have current major depressive disorder with psychotic features.
- Have an active substance use disorder for any substance other than caffeine or nicotine in the past 60 days
- Have a Personality Disorders
- Is presenting current serious acute suicide risk
- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
- Require ongoing concomitant therapy with a psychiatric medication that could adversely interact with MDMA.
- Have evidence or history of significant (controlled or uncontrolled) haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration or be likely to produce significant symptoms that during the study could interfere with participation or be confused with side effects of MDMA (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). Note: if participants present with a history of glaucoma, enrolment would be allowed only with the approval of their ophthalmologist
- Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 millimetres of Mercury [mmHg] or higher assessed on three separate occasions).
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds corrected by Bazett’s formula).
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome).
- Have symptomatic liver disease.
- Have history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms.
- Are pregnant or breastfeeding, or are of childbearing potential and are not practising an effective means of birth control.
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Interventions
This is a proof-of-concept open label trial of MDMA-assisted psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD) among four people using the Multidisciplinary Association of Psychedelic Studies (MAPS) MDMA-assisted psychotherapy treatment protocol. The treatment period will commence after a baseline measure of PTSD has been obtained using the CAPS-5 and provided in accordance with the MAPS manualised MDMA-assisted psychotherapy over ~12 weeks. The psychotherapy is provided by a male/female co-therapy team. A total of 15 psychotherapy sessions are provided in each treatment of MDMA-assisted psychotherapy. The psychotherapy sessions are delivered in accordance with the Multidisciplinary Association for Psychedelic Studies’ (MAPS) MDMA-assisted psychotherapy therapy treatment manual, which is underpinned by a humanistic/transpersonal psychotherapy approach. This includes three preparation sessions before the first MDMA session. Each preparation session is ~1.5 hours in duration and occur weekly. Each of the three MDMA sessions involves ~8 hours of drug-assisted psychotherapy and requires an overnight stay. This is followed by an integrative psychotherapy session the next morning at the hospital that is ~1.5 hours in duration. Two additional integrative sessions of non-drug psychotherapy are then provided before and after the second and third MDMA-assisted sessions that also last ~1.5 hours. Each MDMA session involves the administration of two doses of MDMA that is provided to participants a capsule that is to be taken orally. The first dose is administrated early in the morning within 1 hour of commencing the MDMA session and is followed by a supplementary dose at 2.5 hours after initial administration. The initial doses of MDMA provided in first MDMA sessions is 80 mg of MDMA, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg). The second and third MDMA sessions involve an initial flexible dose of either 80mg or 120mg, depending on the participant's response to the first MDMA session, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg or 60mg). The MDMA will be provided to participants in a capsule. The first MDMA session should occur about ~4 weeks after a baseline measure of PTSD has been obtained using the CAPS-5, after which time the preparation sessions will have been also completed. These sessions involve the co-therapy teams understanding the nature of the index trauma, providing the participant with information about the effects of MDMA in the context of MDMA-assisted psychotherapy and assisting the participant develop their intention for the MDMA session. These sessions are completing in accordance with the MAPS MDMA-assisted psychotherapy therapy treatment manual. The second MDMA session should occur within ~3 weeks of the first MDMA session and the third MDMA session should occur within ~3 weeks of the second MDMA sessions. Participants are required to agree to a range of lifestyle modifications prior to engaging in the treatment and a checklist of these lifestyle modifications is completed prior to each MDMA session (including a urine screen for illicit drug use and pregnancy). The administration of the MDMA is overseen by the co-therapy team, a psychiatrist, and a nurse.
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ACTRN12621001078842