Establishing a safe setting for the participant requires that the therapists take an active role in creating an environment that is conducive to the full range of the MDMA therapeutic experience. The therapists create a favorable setting through the strategies listed below. They must provide a setting in which the participant is able to recline comfortably. In order to minimize any unfavorable distractions the setting should be free of all objects that would be likely to have powerful negative or disturbing connotations. The research setting will be made as supportive as possible, yet the participant can be aware of all safety measures in place to respond to the unlikely possibility of a medical complication. The participant is provided with eye shades and a pre- selected program of music. Music for the drug session is selected on the basis of its ability to elicit emotional responses or to facilitate a sense of passage or transformation. Music is chosen to support emotional experience while minimizing suggestion, with music containing lyrics generally avoided (Groff, 2000).

The creation of a safe physical and psychological space will allow and encourage the participant to attend to his/her internal stimuli. The setting as a whole is designed to minimize the impact of external stimuli and to support the participant's attention to his/her intrapsychic process. The participant has the option to request periods of silence and the therapist has the option to forgo sections of the musical program. Participants may also elect to forgo eyeshades.

To maximize the creation of a safe psychological space, the therapist and participant discuss the parameters of each session. The therapists and the participant make several specific agreements. These agreements include the following:

1. The participant, accompanied by a trained attendant, agrees to remain overnight in the clinic or office. The participant is permitted to have his/her significant other spend the night unless contraindicated by the clinicians.
2. The participant agrees to have a prearranged ride home the following morning.
3. At least one of the therapists is present at all times during the entire MDMA session.
4. The participant's psychological safety also includes establishing the parameters with respect to experiencing and expressing sexual feelings. The role of the therapists' possible physical contact with the participant in the form of bodywork and nurturing touch will be discussed. The therapists assure the participant that at no time will they engage in any form of sexual contact. The participant is invited to ask for nurturing touch, (holding of a hand or being held). The participant is also instructed to use the word "stop" as a specific command if the therapists are doing anything the participant wants them to discontinue. The therapists agree to always respond to this command; the only exception being when the therapists are doing something to the participant that is necessary for the participant's safety.
5. The participant agrees to refrain from self-harm, harm to others, and harm to property. If, in the judgment of the therapists, the participant is engaged in any dangerous behavior, the participant complies with the therapists request to stop according to the terms of this agreement. The participant understands that failure to respond to the request may require an appropriate level of intervention.

Therapist: "What is on your mind since our last session? Any questions or thoughts?"

Participant: "I've been through a gamut of emotions, nervous, anxious and not sleeping well. I just don't feel rested, dragging myself out of bed. I'm real tired."

Therapist: "Do you have an idea about what the anxiety is about?"

Participant: "I think it is about the upcoming study. I really can't think of anything else. It's the unexpected. I am not good at surprises. I want to know what's coming from one day to the next."

Therapist: Long silence.

Participant: (Crying) "It scares me."

Therapist: "Say more about what scares you."

Participant: "I am afraid I'll be a different person. What if I get rid of all of this and Tom won't love me anymore? What if I'm not the person he fell in love with? He reassured me that this was silly. But I have been like this for so long. Who am I? What if I am not really a person? What if? What if? I can come up with a thousand rationales for why I am like this."

Therapist: "That is a real issue; however, in reality you'll be more deeply yourself. You'll be reconnected with yourself in a deeper way."

Therapist: "One thing you said earlier was that you wanted to run off and hide. Maybe you lost part of yourself, a part of you disappeared."

Participant: "I think there was a lot of me that disappeared."

Therapist: "So this might be an answer without having to run away. You may find that you become more deeply yourself. You are willing to do this and face it." The participant is aware that he/she will be in a heightened state of vulnerability and will likely experience a range of emotions, thoughts, and physical sensations. The therapists discuss the process of helping the participant gain relief from difficult, intense emotions or distressing thoughts and assure the participant that he/she is in a safe environment and under the care of experienced clinicians. The participants are taught diaphragmatic breathing techniques to aid in the relaxation and self-soothing process. They are also taught to use awareness of the breath as a technique for being able to attend to experiences, especially difficult experiences from which they might otherwise attempt to distance themselves.

Another important aspect of developing a psychologically and physically safe space involves a joint exploration of the members of the social support system surrounding the participant. Prior to any MDMA-assisted treatment session, the therapists and participant may consider ways in which the members of his/her social support network can be of help to the participant during the time between therapy sessions. The therapists should explain the potential value of sharing knowledge about the treatment sessions with selected members of the participant's social support system. The participant may choose to invite a significant other (friend, family member or partner) to spend time with them at the close of at least one MDMA session. Depending on the nature of the relationship with the significant other, this may be a valuable experience that enhances the supportive relationship. It should be cleared in advance with the therapists based on the same clinical judgment they would use in considering the therapeutic value of an overnight stay by a significant other.

Maintaining a safe physical space includes access to treatment for possible reactions to the medicine during or immediately after each treatment session. Most reactions can be dealt with through supportive care, but some reactions, such as hypertensive reaction, may need additional intervention. MDMA-assisted psychotherapy should be done in a setting where Advanced Cardiac Life Support (ACLS) is rapidly available in the unlikely event of an acute cardiovascular complication. The clinic or office where the MDMA session will occur should have means of readily assessing blood pressure and heart rate or pulse during the MDMA session. When providing beverages throughout the MDMA session, the therapists should ensure that patients do not consume over 3 L over the course of the MDMA session, and they may wish to provide electrolyte-containing beverages (such as Gatorade) instead of water as a means of reducing risk of hyponatremia. Therapists should make contingency plans for responding to other unlikely events. In this early pilot study, the therapists are prepared to treat a number of unlikely adverse events, and they will have an emergency medicine physician and nurse present for five hours after drug administration.