MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Condition: Anxiety
MeSH terms: Anxiety Disorders
Intervention: MDMA (125 mg); Placebo; Therapy
Intervention description: Two sessions of MDMA (with therapy) lasting six to eight hours, scheduled two to four weeks apart.; Two sessions of placebo (with therapy) lasting six to eight hours, scheduled two to four weeks apart.; Non-directive therapy
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anxiety; MDMA; Life-threatening illness; Therapy

Summary:

      This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18
      participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy.
      Thirteen participants were randomized to the active dose condition of 125 mg of MDMA (plus an
      optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were
      randomized to the placebo with therapy condition. The study will consist of two blinded
      experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting
      six to eight hours and scheduled two to four weeks apart. Each participant will be unblinded
      one month after their second experimental session in Stage 1. After unblinding, participants
      receiving placebo will have the opportunity to cross over to open-label Stage 2 and receive
      active MDMA. Only subjects who receive active dose MDMA will complete an optional third
      open-label experimental session.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with life-threatening cancer or non-dementing neurological illness, which
             can be ongoing or in remission, but with a possibility of recurrence

          -  Prognosis of at least nine months life expectancy from the time of screening

          -  Have anxiety as a result of facing their illness

          -  Are at least 18 years old

          -  Are willing to refrain from taking any psychiatric medications during the study
             period;

          -  Are willing to commit to medication dosing, experimental sessions, follow-up sessions,
             and to complete evaluation instruments

          -  Are willing to remain overnight at the study site after each experimental session
             until after the integrative session occurring the next morning

          -  Must sign a medical release for the investigators to communicate directly with their
             therapist and doctors;

          -  Are willing to select up to three observers who will complete observer measures of
             subject attitudes and behavior

          -  Negative pregnancy test if able to bear children and agree to use effective birth
             control

          -  Are proficient in speaking and reading English

          -  Agree to have all psychotherapy sessions recorded to audio/video.

        Exclusion Criteria:

          -  Are pregnant or nursing, or if a woman who can have children, those who are not
             practicing an effective means of birth control;

          -  Weigh less than 48 kg

          -  Are abusing illegal drugs

          -  Are unable to give adequate informed consent

          -  Upon review of past, current drugs/medication must not be on or have taken a
             medication that is exclusionary

          -  Upon review of medical or psychiatric history must not have any current or past
             diagnosis that would be considered a risk to participation in the study