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

NCT00252174 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-11-14

Study results available
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Summary

This is a pilot study intended to find out if 3,4-methylenedioxymethamphetamine (MDMA) is safe and can help people with advanced stage cancer and anxiety arising from the cancer diagnosis.

Conditions

Interventions

DRUG

Stage 1 Active Methylenedioxymethamphetamine

Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.

DRUG

Stage 1 Low dose Methylenedioxymethamphetamine

Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.

BEHAVIORAL

Psychotherapy

Psychotherapy conducted with low or active dose MDMA

DRUG

Stage 2 Active Methylenedioxymethamphetamine

Administered open label Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.

Sponsors & Collaborators

  • Mclean Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • John H Halpern, MD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252174 on ClinicalTrials.gov