What is the purpose of the study?
Advanced-stage cancer is associated with high rates of anxiety and depression. These disorders can significantly impact quality of life. Early research suggests that MDMA (3,4-Methylenedioxymethamphetamine; ecstasy) administered alongside supportive talk therapy may be effective in reducing mood and anxiety symptoms in people with advanced-stage cancer. In the USA, there have been recent studies using MDMA-assisted therapy for PTSD and anxiety in life-threatening illnesses. In New Zealand, research has been conducted on MDMA for tinnitus with no adverse effects. The purpose of this study is to investigate the safety, tolerability, and effectiveness of MDMA compared with a control medication (methylphenidate) alongside talk therapy for participants with advanced-stage cancer who have depressive and/or anxiety symptoms. The study may result in a new treatment for anxiety and depression in advanced stage-cancer.
How is this study designed?
This is a dual site double-blinded randomised controlled trial to assess the effects of MDMA-assisted therapy versus a psychoactive control treatment (methylphenidate) on depression and anxiety symptoms in patients with advanced-stage cancer.
In this study, 32 participants will be randomized on a 1:1 ratio to receive one of two oral medications (an active control or MDMA) alongside talk therapy. Participants will be monitored to assess their physical health and will complete questionnaires that assess their psychological well-being prior to treatment and post-treatment. All participants will undergo two 90-minute preparation talk sessions before undergoing a medication treatment session lasting approximately 8 hours where they will receive one of the two oral medications. The medication treatment session will be administered in a comfortable clinical setting and participants will be closely observed and supported by a qualified healthcare provider (physician, psychologist, nurse). Therapists and support staff will be available by telephone for 24 hours following dosing with MDMA. The following day, all participants will undergo a 90-minute talk therapy session to discuss their experience.
Who is Able to Take Part in the Study?
If you have stage 4 cancer and have a prognosis of greater than 3 months you may be eligible for this study. Please discuss eligibility with your GP, Oncologist or Palliative Care Physician.
What are the possible benefits of this study?
It is possible there may be no specific benefits for you after the medication-assisted therapy. It is possible that you will experience a reduction in distress and depressive/anxiety symptoms. You will have a medical examination and blood test to assess your health and you can request a copy of your medical results at any time. The results of this study could potentially help with the treatment of depressive and anxiety symptoms in people with advanced-stage cancer in the future.