Clinical TrialAnxiety DisordersMDMAMDMAMDMATerminated

MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer

Pilot randomised, triple-blind Phase II study testing MDMA-assisted psychotherapy in people with advanced-stage cancer and anxiety; Stage 1 randomised (full vs low MDMA doses) with optional Stage 2 open-label extension.

Target Enrollment
2 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, parallel Phase II pilot examining MDMA-assisted psychotherapy for anxiety related to advanced-stage cancer; Stage 1 randomised to low versus near-full MDMA doses, with a Stage 2 open-label extension for low-dose participants.

Dosing in Stage 1: Session 1 initial 83.3 mg with optional 41.7 mg supplement (total 125 mg); Session 2 125 mg with optional 62.5 mg (total 187.5 mg). Low-dose arm: 25 mg with optional 12.5 mg (total 37.5 mg) per session. Two MDMA-assisted sessions per stage.

All participants receive six one-hour preparatory psychotherapy sessions and MDMA-assisted sessions lasting six to eight hours with an overnight stay; psychotherapy is conducted by the same therapists across sessions.

Outcomes include anxiety and quality-of-life measures at baseline, pre- and post-sessions, 1-week post-MDMA, and final study visit (~84 days), plus diaries of medication use and pain; medical examinations performed during follow-up.

Study Protocol

Preparation

6 sessions
60 min each

Dosing

2 sessions
420 min each

Integration

0 sessions

Therapeutic Protocol

support

Study Arms & Interventions

Stage 1 active

experimental

Full-dose MDMA (higher-dose arm) with psychotherapy, two MDMA-assisted sessions.

Interventions

  • MDMA125 - 187.5 mg
    via Oral• two sessions• 2 doses total

    Session 1: 83.3 mg + optional 41.7 mg (total 125 mg); Session 2: 125 mg + optional 62.5 mg (total 187.5 mg).

Stage 1 low dose

active comparator

Low-dose MDMA comparator with psychotherapy, two MDMA-assisted sessions.

Interventions

  • MDMA37.5 mg
    via Oral• two sessions• 2 doses total

    Session doses: 25 mg + optional 12.5 mg (total 37.5 mg) per session.

Stage 2 open-label

experimental

Open-label MDMA and psychotherapy for up to 4 participants who crossed over from low-dose arm.

Interventions

  • MDMA125 - 187.5 mg
    via Oral• two sessions• 2 doses total

    Open-label: same dosing schedule as Stage 1 active (83.3→125 mg; 125→187.5 mg with optional supplements).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis with advanced-stage cancer (usually meaning inoperable or incurable) with a life expectancy of less than 12 months.
  • Anxiety as a result of cancer diagnosis.
  • Failure to respond adequately or at all to medication intended to reduce anxiety, or have refused to take anxiolytic medication.
  • Completed or independently decided to end all direct cancer treatments (e.g., chemotherapy, radiation) two weeks prior to the first experimental (MDMA) session, or receiving only palliative cycles and completed last cycle at least two weeks prior to first MDMA session.
  • Willing to commit to and follow all directions and restrictions relating to the study period.
  • Willing and able to discontinue use of psychiatric medication except anxiolytics (if still taking, medication will be discontinued long enough before first MDMA session to avoid interaction).
  • Willing and able to stay overnight at the facility after each MDMA-assisted session.
  • If seeing another psychotherapist, willing to give PI permission to communicate with them.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception.

Exclusion Criteria

  • People with a life expectancy of longer than 12 months.
  • Women who are pregnant or nursing, or of childbearing potential not using effective birth control.
  • People with any dissociative disorder, anorexia nervosa, bulimia nervosa, a primary psychotic disorder or affective disorder other than anxiety related to advanced stage cancer.
  • People diagnosed with abuse of or dependence on any substance (other than caffeine or nicotine) in the past 60 days.
  • People with known primary or metastatic cancer of the CNS.
  • People with significant, unstable hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease (including seizure disorder) that poses too great a potential for side-effects.
  • People with significant peripheral vascular disease, hepatic disease, renal insufficiency, or preexisting or past evidence of hyponatremia.
  • People diagnosed with hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg will exclude).
  • People with liver enzyme values indicative of severely compromised hepatic function.
  • People who weigh less than 45 kg (98 lb).
  • People reporting use of "ecstasy" (illicit preparations purported to contain MDMA) within the previous 3 months.
  • People reasonably judged to present a serious suicide risk or who are likely to require psychiatric hospitalization during the course of the study.
  • People requiring psychotropic medication other than anxiolytic medication or for pain control.

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment2 participants
  • Timeline
    Start: 2007-01-12
    End: 2011-01-03
  • Compounds
    MDMAMDMAMDMA
  • Topic
    Anxiety Disorders

Locations

McLean Hospital — Belmont, Massachusetts, United States

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