Clinical TrialDepressive DisordersMDMAPlaceboRecruiting

A double-blind, randomised trial of methylphenidate-assisted versus MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients

This double-blind, randomised, parallel Phase II trial (n=32) compares single-dose MDMA-assisted therapy (120 mg, optional 60 mg supplemental) versus methylphenidate-assisted therapy (20 mg, optional 10 mg supplemental) for depressive and anxiety symptoms in people with advanced-stage cancer.

Target Enrollment
32 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

Participants receive one 8-hour supervised medication-assisted therapy session (MAPS model) with two therapists; preparation comprises two 90-minute sessions and integration one 90-minute session.

MDMA arm: 120 mg oral dose with optional 60 mg supplemental at ~2 hours if safety and participant preference allow. Methylphenidate arm: 20 mg oral dose with optional 10 mg supplemental. Safety monitoring includes BP and pulse checks prior to supplemental dosing.

Primary outcomes include change from baseline in MADRS and IPOS at Day 28 (±3 days); study conducted in New Zealand with University of Otago sponsor.

Study Protocol

Preparation

2 sessions
90 min each

Dosing

1 sessions
480 min each

Integration

1 sessions
90 min each

Therapeutic Protocol

maps

Study Arms & Interventions

MDMA-assisted therapy

experimental

Single supervised MDMA-assisted therapy session (MAPS model) with optional supplemental dose at 2 hours.

Interventions

  • MDMA120 - 180 mg
    via Oral• single dose

    Optional supplemental 60 mg offered ~2 hours after initial dose if safety criteria met and participant agrees; 8-hour supervised session.

Methylphenidate-assisted therapy

active comparator

Single supervised methylphenidate-assisted therapy session with optional supplemental dose at 2 hours.

Interventions

  • Placebo20 - 30 mg
    via Oral• single dose

    Optional supplemental 10 mg at ~2 hours if criteria met and participant agrees; therapy procedures mirror MDMA arm.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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.
  • 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 and comply with fasting and medication restrictions prior to Experimental Sessions; not participate in any other interventional clinical trials during the study; remain at the study site after each Experimental Session until cleared to be driven home.

Exclusion Criteria

  • 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. Taking a medication that is exclusionary or has not completed required washout per Study Reference Manual.
  • 6. Liver function test >3× ULN or creatinine clearance <30 mL/min.
  • 7. Any current serious suicide risk as determined by psychiatric interview, C-SSRS, and clinical judgement; history of suicide attempts is not automatically exclusionary; recent suicidal behaviour may exclude (see suicidality details).
  • 8. Medical conditions that make sympathomimetic drugs hazardous (e.g., recent MI, cerebrovascular event, aneurysm) unless site physician deems risk acceptable.
  • 9. Uncontrolled essential hypertension per AHA criteria.
  • 10. History of ventricular arrhythmia (with exceptions) or significant QT/QTc prolongation.
  • 11. Use of concomitant medications that prolong QT/QTc during Experimental Sessions.
  • 12. Any condition judged by investigator to interfere with participation.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment32 participants
  • Timeline
    Start: 2023-07-31
    End: 2024-12-30
  • Compounds
    MDMAPlacebo
  • Topic
    Depressive Disorders

Locations

Unknown facility — Australia

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