A primary role of the therapist in MDMA-assisted therapy is to create and maintain a safe therapeutic alliance with the participant. A key requirement for this is the therapists' own self-awareness. The therapists consider the psychological factors influencing the participant, including the participant's expectations of the therapists (Widmer, 1997). They must be fully present during the participant's processing of trauma and at the same time, maintain healthy, appropriate boundaries. This provides support for the participant to remain present with his/her inner experience and enhances the participant's willingness to explore new and unexpected perceptions which may arise during the healing process. The strength of the therapeutic experience during the treatment session relies heavily on the therapists' ability, their level of comfort with intense emotions, and their skill in remaining empathically present and open to a range of emotional experiences the patient may undergo. The therapists maintain an awareness of the participant's intentions for the session while allowing for additional psychic material to emerge. In order to maintain the delicate balance between focusing on the inner experience and providing a safe space for exploring this experience, the therapists must be prepared to respect the natural healing mechanisms of the participant's own psyche and body. This involves skillfully interweave interaction with the patient and periods of silent witnessing.

Participant: "When my brother left there was just no contact for me. I really felt abandoned. He was a rock for me. I could feel safe. He was a really good brother and then he went to California and he was gone."

Therapist: "Do you think it would be a good time to go inside and work with those feelings?"

Participant: "Yeah"

Therapist: (After a long silence). "How is it going in there?"

Participant: "It is really crazy. And not all of what I was expecting. ... I don't know if I can even verbalize it. Some of it is really dark and some of it is not. It is kind of anxiety provoking. It's like stuff I had no idea was in me. I am OK being there. It's not realistic at all. I am not really trying to connect it with anything. It is kind of like I want to get out of my skin. I kept wanting to stop and then stay. I'll stop if it gets too weird."

Therapist: "It isn't necessary to feel as though you have to verbalize it right at this point."

Participant: "OK"

During the MDMA treatment session, the therapists act both as guides and supportive figures. As guides, the therapists facilitate the healing process and encourage the participant to focus on his/her goals when appropriate. This role may require therapists to redirecting behavior, as when participants are requested to discontinue talking if it is felt that the communication represents either a defensive avoidance of material or a distraction from the opportunity to experience and benefit from the unique effects of the medicine. These MDMA effects can lead to important insights and healing that arise through a non-linear process. This process is enhanced by holding an attitude of allowing the medicine to bring forth experiences rather than by any intervention. It is a posture of acceptance rather than analysis. Another aspect of this role may require the therapist to follow the participant as he/she explores new and unexpected perceptions, even if they appear to be leading away from the primary agenda.

As nurturant figures, the therapists provide support and comfort to the participant and assist him/her in facing overwhelming and upsetting thoughts, memories or feelings. The therapists encourage the participant to move toward reaching new perceptions or insights. This is accomplished through empathic listening, questions or observations that may help amplify the experience, verbal and physical comfort on request, and techniques to relax and gain a sense of security in the face of trauma related feelings. At other times, participants may describe experiences of exhilaration, joy, resolution or self-affirmation. The therapists, as guides, provide the patient with room for these expressions and encourage the participant to accept and perhaps further explore these experiences. The therapists may inquire as to how the participant experiences these feelings as part of his/her healing process. These experiences may serve to soften or reduce the intensity of distressing memories, thoughts or feelings and may provide a life- affirming perspective for the participant.

Participant: "This is such a fun way to spend the day. I am really having a lot of fun. I was thinking that I hope you guys are having as much fun as I am. (Laughs).

Therapist: "We are. Thank you."

Participant: "This is what I love about this work. It is, like so beautiful on one level. I feel like every one should have the experience of what the collective unconscious is and about how full we are. It is just really lovely. Some of it is painful and creepy too, but a lot of it for me is just so, I am going `Wow I can't believe I have this in my head. I can't believe it is in me.' It is really a neat experience. It is very reassuring because even when it gets dark and kind of uncomfortable, I am like, I feel very clear that it is just part of what I am made of and it is OK."

Agreements concerning appropriate behavior during the treatment session are integral to the therapeutic and nurturing role of the therapists. Prohibiting any sexual behavior between therapists and participant assures participants that their heightened vulnerability will not be exploited, and simultaneously fosters a safe environment for offering physical comfort during the treatment session. Insistence that the participant remain within the confines of the treatment area until the completion of the sessions is important for participant safety, and provides assurance to the participant that the therapists will not allow him or her to leave the safe space until the return of ordinary consciousness. The therapists provide verbal and physical comfort upon request. This may include reminding the participant of the therapists' presence and reminding the participant that he/she can use breathing exercises or request bodywork if needed. The therapists also maintain a safe space through the immediate discontinuation of any action, including verbal or physical contact, when the patient says "Stop". Support is also offered through reminding the participant of his or her own strengths and the tools that he or she possesses, such as new insights or self-soothing skills that can be used in the face of intense emotional experience.

In conducting MDMA-assisted treatment sessions, therapists must attend to balancing their responsibilities as facilitators and as noninvasive participant observers. This may prove challenging at times, particularly when the therapists must decide when it is desirable for the participant to explore and confront his/her inner experience and when interaction with the therapists is appropriate for to facilitate a particular avenue of experience.

The therapists may also assist the participant in examining and negotiating ambivalent feelings toward the appropriateness of emotions or thoughts he or she is experiencing during the MDMA session. For example, the participant may experience cognitive dissonance between newfound feelings of self-forgiveness and self-acceptance and habitual thoughts of self-blame and self-loathing related to the traumatic experience(s). Here the therapists must determine whether or not to intervene. In either case, the therapists seek to maximize the potential benefits of the MDMA-facilitated inner experience while at the same time ensuring that participant is safe and is not re- traumatized by the internal conflict. Maintaining this balance requires a focus on the verbal and nonverbal communications of the participant, and an understanding of any potential difficulties the participant might be facing as a part of his/her healing process. Toward the end of the session as the participant is making the transition from the non- ordinary to the ordinary state of consciousness, the therapists assess the participant's emotional stability, alertness and whether or not the participant continues to experience altered perception, using the methods described above for the first MDMA session. The therapists will only allow the MDMA session to end when they believe that the participant is stable and alert. In the event that the patient is experiencing residual emotional distress, the therapists will use clinical judgment to asses the apparent intensity of distress and to gauge what interventions should be employed. In most cases, the proper intervention will be to allow the participant to express his/her feelings, and to help him/her understand the importance of these feelings in the overall healing process. The therapists will only depart from the clinic when they have concluded that the participant is emotionally stable and that most MDMA effects have subsided.

The participant should be reassured that, though the acute effects of the MDMA have worn off, the effects of the MDMA session inevitably continue to unfold over the hours and days following the session. The participant is also assured that the therapists will continue to provide support and help in working through and resolving any difficulties. At this point in time and prior to leaving, the therapists may wish to review and assist the participant in practicing relaxation and self-soothing techniques that were taught in the introductory sessions. If the participant's distress is not sufficiently decreased by the above measures, the therapists should consider focused bodywork as described in Appendix A. As described above, a "rescue medication" may be administered if extreme anxiety persists and all other interventions have failed to reduce anxiety to a tolerable level.

If all means of reducing the participant's distress have failed and the patient remains severely anxious, agitated or in danger of self harm or suicide, or is otherwise psychologically unstable at the end of this two hour stabilization period, the therapists may decide between one of two options. The therapists may then meet with the participant daily until the period of destabilization has passed. The second option is for the patient to be hospitalized until she or he is in a stable condition. All patients will be aware of these possibilities when consenting to undergo MDMA-assisted psychotherapy. The therapists are only likely to use these options under extreme conditions, and all other options will be tried prior to hospitalizing the patient.

As described above, the principal investigator/therapist is responsible for disqualifying any patient who had an adverse physiological or emotional response to MDMA during the first session sufficiently severe to indicate that he/she would be at risk during a second MDMA session. All participants eligible for a second MDMA session should discuss their thoughts and feelings about undergoing the second session. The consequences of continuing MDMA-assisted therapy and the consequences of discontinuation will be frankly discussed. The participant's decision about what he or she would prefer is respected unless the therapists have an overriding reason for excluding the participant on grounds of safety.

At the end of the MDMA session or upon departing on the night of the session, the therapists may provide the patient with specific suggestions to write about his/her thoughts, feelings, and experiences of the day, and to bring this writing to the follow-up session. The patient will also be encouraged to pay close attention to his/her dreams. In early and pilot studies, the therapists will contact the participant for a week after each MDMA session. The therapists will use clinical judgment to assess the psychological well-being during this time period.