Effect of 3, 4-Methylenedioxymethamphetamine (MDMA)-assisted therapy on Mood and Anxiety symptoms in patients with advanced-stage Cancer Study (EMMAC Study)
- Conditions
- Depression symptomsAnxiety symptomsAdvanced-stage cancerMental Health - AnxietyMental Health - DepressionCancer - Any cancer
- Registration Number
- ACTRN12619001334190
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
1.Diagnosed with advanced-stage cancer (stage 3 or 4).
2.Prognosis of at least 3 months life expectancy from the time of screening
3.DSM-5 diagnosis of a depressive disorder, an anxiety disorder, and/or an adjustment disorder/stress reaction.
4.MADRS score > 15 and HAM-A score > 12
5.Are at least 18 years old
6.Are able to swallow pills
7.The participant agrees to have study visits recorded
8.Must agree to inform the investigators within 48 hours of any medical conditions and procedures
9.Must be willing for the investigators to communicate directly with their medical team (oncologist, GP, palliative care physician, etc).
10.Agree to refrain from starting any new psychiatric medication and/or psychotherapy during the study period.
11.Willing to follow restrictions and guidelines concerning consumption of food, beverages, including caffeine and nicotine the night before and just prior to medication dosing.
12.Agree to have transportation other than driving themselves to where they are staying on the day of medication dosing.
13.Are able and willing to be contacted via telephone for all necessary telephone contacts.
14.Must have a negative pregnancy test if able to become pregnant, and agree to use an effective form of contraception for 10 days following the last experimental session if of child-bearing potential (Effective forms of contraception include: IUD, injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones. Not of childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.).
15.Must provide a contact/support person in the event of the participant being unreachable by study staff or in the event of severe emergent distress or suicidality.
16.Are proficient in speaking and reading English.
17.Agree to not use any medications on the prohibited medications list during the study.
18.Agree to the lifestyle modifications illustrated below, comply with requirements for fasting, refrain from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain at the study site after each Experimental Session until cleared to be driven home after, and commit to medication dosing, therapy, and study procedures.
All participants must agree to the following lifestyle modifications at enrollment and throughout the duration of the study. Participants are eligible to enroll in the study if they:
•Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact.
•Agree to not participate in any other interventional clinical trials during the duration of this study.
Leading up to Experimental Sessions
•Agree to take nothing by mouth except alcohol-free liquids after 12:00 A.M. (midnight) the evening before each Experimental Session.
•Refrain from the use of any psychoactive medication not approved by the research team from Baseline through Study Termination.
•Agree not to use caffeine or nicotine for 2 hours before and at least 6 hours after the initial dose during each Experimental Session.
•Are willing to comply with medication requirements per protocol. Medic
1.Pregnancy or lactation
2.BMI < 15
3.Recent or current use of illicit drugs including methamphetamine, heroin, and synthetic cannabinoids. Other non-prescribed drugs will prompt exclusion at the discretion of the study physician
4.Unable to give adequate informed consent
5.Upon review of past and current drugs/medication must not be taking a medication that is exclusionary (see Study Reference Manual), or has stopped taking an exclusionary drug for less than the requisite washout period (see Study Reference Manual)
6.Liver function test >3 times the upper limit of normal or creatinine clearance <30 mL/min
7.Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk for participation in the study. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgement of the investigator will be excluded; however, history of suicide attempts is not, in itself, exclusionary. Any participant who is likely to require hospitalization related to suicidal ideation and behaviour, in the judgement of the Study physician will not be enrolled. Any participant presenting with the following on the Baseline C-SSRS will be excluded:
- Suicidal ideation score of >4 within the last month, at a frequency of once a week or more
- Suicidal ideation score of 5 within the last 6 months
- Any suicidal behaviour, including suicide attempts or preparatory acts, within the last 6 months. Participants with non-suicidal self-injurious behaviour may be included if approved by the Study physician
8.Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm. Participants with other mild, stable chronic medical problems may be enrolled if the site physician, CI, and Study physician agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP. Examples of stable medical conditions that could be allowed include, but are not limited to diabetes mellitus (Type 2), human immunodeficiency virus (HIV) infection, gastroesophageal reflux disease (GERD), etc. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism would require exclusion.
9.Have uncontrolled essential hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of mercury [mmHg] or higher assessed on three separate occasions).
10.Have a history of ventricular arrhythmia at any time, other than occasional premature atrial contractions (PACs) or premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
11.Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
12.Have a history of arrhythmia, other than occasional PACs or PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method