Drug assisted psychotherapy to treat posttraumatic stress disorder in war veterans, using 3,4-methylenedioxymethamphetamine (commonly known as MDMA).
A Randomised, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Manualised Psychotherapy in Australian War Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD).
Psychedelic Research in Science & Medicine Inc
14 participants
Sep 2, 2013
Interventional
Conditions
Summary
This is a Phase 2 randomised, multi dose, double-blind study to assess the safety and efficacy of MDMA-assisted manualised psychotherapy in Australian military war veterans with chronic, treatment-resistant PTSD.
Eligibility
Inclusion Criteria7
- Meet DSM-IV criteria for chronic PTSD with a duration of at least six months.
- Have a CAPS score of 50 or higher, indicating moderate to severe PTSD symptoms.
- Have had at least one unsuccessful attempt at treatment for PTSD using drugs (SSRI, SNRI or MAOI) and/or psychotherapy; OR who discontinued treatment due to either: inability to tolerate psychotherapy for PTSD, or inability to tolerate psychopharmacology for PTSD due to treatment emergent side effects.
- May have a concurrent affective disorder, excepting bipolar affective disorder 1.
- Are war veterans.
- If female and of childbearing potential, must have negative pregnancy test results, be willing to have pregnancy tests and must agree to use an effective form of birth control during throughout the treatment period.
- Are proficient in speaking and reading English.
Exclusion Criteria16
- Are pregnant or nursing, or of child bearing potential and not practising an effective method of birth control.
- Have a personal or immediate family history of or current primary psychotic disorder, bipolar affective disorder type 1, or borderline personality disorder.
- Are diagnosed with dissociative identity disorder or an eating disorder with active purging.
- 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 (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions) unless their hypertension has been successfully treated and is currently well-controlled on antihypertensive medicines. In this case participants with well-controlled hypertension may be enrolled if they pass additional screening to rule out underlying cardiovascular disease.
- Have liver disease.
- Have a history of Diabetes Type I or II.
- Have a history of hyponatraemia or hyperthermia.
- Weigh less than 48 kg.
- Would present a serious suicide risk or who are likely to require hospitalisation during the course of the study.
- Have used “Ecstasy” (material represented as containing MDMA) more than five times in the past 3 years or at any time within 6 months of the MDMA session.
- Require ongoing concomitant therapy with a psychiatric drug, including but not limited to SSRIs, SNRIs, or MAOIs.
- Meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.
- Have glaucoma, significant atherosclerosis or hyperthyroidism.
- Have any current problem, which in the opinion of the investigator or medical
- monitor, might interfere with participation in the study.
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Interventions
This is a two arm, randomised, multi-dose study with an additional open label lead-in for two participants. The open label lead-in will involve two participants receiving two experimental drug-assisted psychotherapy sessions of approximately eight hours duration each, using the full dose of 125mg 3,4-methylenedioxymethamphetamine (MDMA) with an optional supplemental dose 2.5 hours later of 62.5mg MDMA (cumulative dose 187.5mg, administered as capsules). At the commencement of each experimental session the participant will undergo a urine drug screen and pregnancy test, a psychological assessment and then begin acclimatising to the environment. The MDMA will be administered soon afterwards, approximately 30-60 minutes after the session begins. The two drug-assisted psychotherapy sessions will be 3-5 weeks apart and form part of a 12 session treatment over six months, which includes 10 non-drug psychotherapy sessions of 90 minutes duration for preparatory, integrative and follow-up purposes. The session sequence will be as follows. Sessions 1,2,3: Non-drug preparatory psychotherapy. Session 4: Experimental drug-assisted psychotherapy. Sessions 5,6,7: Non-drug integrative psychotherapy. Session 8: Experimental drug-assisted psychotherapy. Sessions 9,10,11: Non-drug integrative psychotherapy. Session 12: Non-drug follow-up psychotherapy. The aim of the open label lead-in is to verify therapist adherence to the psychotherapy manual prior to proceeding with Stage 1. Stage 1 is double-blinded and will compare 125mg MDMA versus 30mg MDMA active placebo in the remaining 12 participants. The 30mg MDMA active placebo is not expected to provide therapeutic benefits and is aimed at ensuring an effective blind by producing some physiological effects. Those randomised to receive the full dose in Stage 1 will receive two drug-assisted psychotherapy sessions and 10 non-drug psychotherapy sessions of exactly the same duration and sequence as those in the lead-in. Those randomised to receive the active placebo in Stage 1 will receive two drug-assisted (active placebo) psychotherapy sessions using 30mg MDMA with an optional supplemental dose of 15mg MDMA (cumulative dose 45mg) and 10 non-drug psychotherapy sessions. The session duration and the sequence of the 12 sessions will be exactly the same as those in the lead-in. Stage 2 is an optional treatment for those participants (only) who received the active placebo in Stage 1. After unblinding at the end of Stage 1, eligible participants who choose to complete Stage 2 will undergo an open label full dose treatment involving two drug-assisted psychotherapy sessions and eight non-drug psychotherapy sessions. The session durations will be the same as for the lead-in. The session sequence for Stage 2 is as follows. Session 1: Non-drug preparatory psychotherapy. Session 2: Experimental drug-assisted psychotherapy. Sessions 3,4,5: Non-drug integrative psychotherapy. Session 6: Experimental drug-assisted psychotherapy. Sessions 7,8,9: Non-drug integrative psychotherapy. Session 10: Non-drug follow-up psychotherapy. All study participants will attend an additional long term follow-up session 12 months after their final experimental drug-assisted session.
Locations(1)
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ACTRN12612000219886