MDMA-assisted Therapy in People With Anxiety... — Clinical Trial Details

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.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Stage 1 active

Interventions

Stage 1 low dose

Interventions

Stage 2 open-label

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators