Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on
 mood and psychological experience in people trained to practice MDMA-assistant psychotherapy
 in a therapy-like setting. Study participants will prepare for the experience with the
 investigators. After preparation, they will have two day-long sessions, one with placebo and
 one with MDMA, with the second session happening two days after the first. Order of session
 will be assigned randomly and the study will be double-blind. Subjects will complete measures
 and talk about the experience on the day after each session. Mood, psychological symptoms,
 and interpersonal closeness will be measured before and after each session. The investigators
 will speak with subjects again one and two months after the second experimental session, and
 subjects will complete a personality questionnaire two months after the second experimental
 session.
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.