MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer
Condition: Anxiety Disorder; Cancer
MeSH terms: Anxiety Disorders
Intervention: Stage 1 Active Methylenedioxymethamphetamine; Stage 1 Low dose Methylenedioxymethamphetamine; Psychotherapy; Stage 2 Active Methylenedioxymethamphetamine
Intervention description: 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:
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.; Psychotherapy conducted with low or active dose MDMA; 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.
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDMA; cancer; anxiety; psychotherapy; quality of life

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.
    

Eligibility criteria:

        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, such as
             chemotherapy and radiation, two weeks prior to the first experimental (MDMA) session.
             If subjects wish to initiate or resume treatment for cancer at any point prior to the
             second experimental (MDMA) session, then they will be withdrawn from the study and
             will be asked to see the co-investigator oncologist for a final physical examination.
             Participants will not be withdrawn from the study if they initiate or resume treatment
             after the second experimental (MDMA) session. Those who are receiving cycles of cancer
             treatments for only palliative purposes (no longer for any curative reasons or to
             induce complete remission), may also be included in this study provided that they, as
             well, have completed their last cycle of treatment at least two weeks prior to the
             first experimental (MDMA) session and provided that they will not resume another cycle
             of treatment until after completion of the second experimental (MDMA) session. If a
             subject receiving palliative cancer treatment decides to receive a next cycle of this
             cancer treatment prior to the second experimental session, then, again, they will be
             withdrawn from the study. Participants will not be withdrawn from the study if they
             initiate or resume palliative cancer treatments after the second experimental (MDMA)
             session.

          -  Willing to commit to and follow all directions and restrictions relating to the study
             period

          -  Must be willing and able to discontinue use of psychiatric medication except that
             being used to treat anxiety. If still taking medication when enrolled to the study,
             medication will be discontinued long enough before the first MDMA-assisted
             psychotherapy session to avoid a drug-drug interaction

          -  Must be willing and able to stay overnight at the facility after each MDMA-assisted
             session.

          -  If seeing another psychotherapist, participants must be willing to give the principal
             investigator permission to communicate with him or her.

          -  Female participants of childbearing potential must have a negative pregnancy test and
             must agree to use an effective form of birth control.

        Exclusion Criteria:

          -  People with a life expectancy of longer than 12 months

          -  Women who are pregnant or nursing, or of child bearing potential and are not
             practicing an effective means of 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 in the clinical judgment of the
             investigators 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, even if well-controlled with medication. A
             systolic blood pressure of 140 or greater and/or a diastolic blood pressure of 90 or
             greater will exclude the potential participant from this study.

          -  People with liver enzyme values indicative of severely compromised hepatic (liver)
             function

          -  People who weigh less than 45 kg (98 lb)

          -  People reporting a history of use of "ecstasy" (illicit drug preparations purported to
             contain MDMA) at any time 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