Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers

3,4-methylenedioxymethamphetamine (MDMA) produces changes in feelings and thoughts. It
appears to have a unique pharmacological profile distinct from psychostimulants and classical
hallucinogenic (psychedelic) compounds. Its unique properties have led to interest in using
it in combination with psychotherapy. So far, studies in healthy volunteers have examined the
effects of MDMA in a laboratory setting rather than a psychotherapeutic setting.

This study is a Phase 1 study for up to a hundred people, The information gathered during
this study may help us better understand the psychological effects produced by MDMA and how
those effects can more effectively be used within a therapeutic context, as with people with
PTSD. Participants will be healthy volunteers who have completed a program training them in
conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will
receive placebo and MDMA during two sessions scheduled at least two days apart in a
psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms,
blood pressure, heart rate and body temperature will be measured, and personality will be
measured prior to the first therapy-like session and two months after the second session.

The study will follow a cross-over design, meaning that all participants will receive both
MDMA and placebo, with order of session randomly assigned. Study participants will have a
preparatory session prior to each experimental session and an integrative session after each
session. The researchers will contact them via telephone one and two months after the second
experimental session. By comparing changes in mood, feelings of emotional closeness to the
self and others and psychological symptoms after placebo and after MDMA, the investigators
hope to learn something about the effects of MDMA on mood, subjective experience and the way
we think and feel about others.

Inclusion Criteria:

- have successfully completed a sponsor-supported program for training therapists to
perform MDMA-assisted psychotherapy research;

- are at least 21 years old;

- Are willing to follow all rules and restrictions related to study participation,
including restrictions on medication use for a week prior to experimental sessions and
restrictions on food and alcohol consumption on the day prior to each experimental
session.

- are willing to remain overnight at the study site;

- agree to have transportation other than driving themselves after the integrative
session on the day after each experimental session;

- are willing to be contacted via telephone for all necessary telephone contacts;

- if a woman of childbearing potential, must have a negative pregnancy test and agree to
use an effective form of birth control;

- are proficient in speaking and reading English;

- agree to have all clinic visit sessions recorded to audio and video

Exclusion Criteria:

- are pregnant or nursing, or are women of child bearing potential who are not
practicing an effective means of birth control;

- weigh less than 48 kg;

- have used "ecstasy" (material represented as containing MDMA) within 6 months of the
MDMA session;

- require ongoing therapy with a psychotropic drug;

- Are abusing illegal drugs

- unable to give adequate informed consent;

- Upon review of past and 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.