Onset of subjective and physiological effects begins 30 to 60 minutes after oral administration. During this period of treatment the participant is in a comfortable position and may find it helpful to focus on his/her breathing. The participant will have the option to use eye shades and listen to the music selected for the session. At the beginning of the session participants will have been reminded of their intentions, such as exploring traumatic memories, or exploring ways in which their response to the trauma has affected interpersonal relationships or life course decisions. During this stage of the session it is important that neither the participant nor the therapists be forceful about directing attention toward these goals. It is more useful for all involved to take a stance of openness to whatever unfolds, knowing that the participant's psyche is capable of discovering a route to deep healing that is apt to be more effective and ingenious than the rational mind could have devised. The participant may talk to the therapists at any time.

Therapist: "You mentioned that you're worried that this stuff with your dad may come up and it is fine for this type of material to arise."

Participant: "OK. I feel good about that."

Therapist: "We don't want to direct this nearly as much as we want to follow and support the way it unfolds for you. So we trust that your own inner healing mechanism will bring up whatever needs to come up. As we talked about before, we would like to have an agreement that at some point if nothing about the trauma has come up spontaneously we'll bring that up in some way so that we can work with it. But we will let your own unfolding of the process take the lead."

In some cases the participant may become anxious as they feel the early effects of the MDMA. If they tell the therapists this or if they appear restless during the first hour an interaction with the therapists might be as follows:

Participant: "I feel really weird. My arms and legs feel heavy and tingly"

Therapist: "I want to remind you that you're in a safe place and we're paying close attention to how your body is reacting. Use your breath. What you're experiencing is a normal reaction to the MDMA effect starting. By using your breath like we practiced you can stay with the energy in your body."

Participant: (Begins breathing. Music is soft and melodic.)

Therapist: (After a long silence) "It's very common to have a lot of energy. One thing is to breathe into it and experience it, maybe savor it and also if your body wants to move, just let your body express itself."

Participant: "I need direction. I'm just going every which way. I need something to focus on. I need something to think about ... too many thoughts."

Therapist: I think the best approach at this point is to see what direction the medication gives you. Instead of trying to control your thoughts and self, trust the medicine will unravel these knots in some way and take on direction. I know there is an abundance of energy in your body, so you do not have to make your body relax, just let your thoughts float by."

Peak effects are expected to occur 70 to 90 minutes after drug administration (Harris et al, 2002; Tancer & Johanson 2003; Liechti & Vollenweider, 2001), and to persist for 1 to 1.5 hours. The therapists will check-in with the participant after 60 minutes if the participant has not talked since the administration of the medication. This check-in reminds the participant of the therapists' presence and provides the therapists with a cue as to the participant's inner status. This is a brief interaction that is followed by the therapist guiding the participant to return to an inner focus.

To check in with the participant at 60 minutes one of the therapists may put a hand gently on the participant's shoulder (if the participant has given permission to be touched in this way before the session began) and ask softly,

Therapist: "It's been an hour and we're just checking in to see how you're doing."

Participant: "I don't remember so much about my childhood. It's hard for me to imagine that I can heal this stuff if I don't remember what it is. I just want to dig it out.

Therapist: "So what I encourage you to do right now, in as much as possible, is to stay with all of that including the feelings of frustration and concerns about your not being able to remember. Let yourself just go into feeling all of it and let go of worrying about whether you can remember or not remember. Let go of worrying about how you are going to heal. Breathe into the process and trust your own healing intelligence with the help of the medicine. It will help it unfold the way it needs to."

The majority of the MDMA-treatment session consists of the participant attending to his/her intrapsychic experience and the therapists maintaining a clear empathic presence in order to attend to the process of the MDMA-treatment session. As the session progresses, the participant is likely to experience a positive mood and a sense of trust for both self and others, along with facilitated recall, which can result in the emergence of difficult and painful emotions and memories. Ideally the effects of the MDMA and the therapeutic set and setting will lead to catharsis and improvement.

Therapist: "You were beginning to sense the fear."

Participant: "It changed from fear to `I'm really mad at myself for allowing it to happen."

Therapist: "Is that easier to feel than the fear?'

Participant: "I guess so."

Therapist: "Because you were experiencing that and the fear began to come up and I invited you to go inside and feel the fear. How long before it switched to the anger?"

Participant: "Not long at all."

Therapist: "Your mind does that to distract you from the feeling of fear."

Participant: "That's possible. After the initial, `What the hell is going on, my mind clicked into `This is not happening. This is just too absurd to be happening ... all the way back to when I was little ... I never felt protected, really. There's never been any support. I wasn't free to be me ... just what the situation called for. I had to do it then too, be what the situation called for."

Therapist: Long silence.

Participant: "I feel like a lot of this baggage I've been carrying around I put onto myself ­ either disappointment in myself or self blame. I mean, don't get me wrong under no circumstances do I think I deserved it or asked for it or I did something to bring that on. I don't feel that way at all. It's like your baseline and you've got your self-doubt, desperation on top of that and before you know it you've got a 7 layer burrito. I can feel every one of them. I don't know how to express it or articulate it but I can feel every one of them. It's not the "Yuck" that I used to describe. They're stacked one on top of the other. I guess I have just done it for so long that when the rape happened it was the straw that broke the camel's back. I just left. My mind said that's enough, no more."

The effects of MDMA-assisted psychotherapy are expected to assist the participant to face the traumatic memories and associated thoughts and emotions. Enhanced self-acceptance and decreased self-criticism may increase self-confidence, a sense of self-efficacy and control over unfolding memories, thoughts or feelings. A sense of inner calm, rather than extreme arousal, on confronting trauma-related material is expected to help the participant examine memories and thoughts more closely and objectively, while at the same time encouraging the participant to allow powerful emotions to surface. The sense of safety and facilitated recall may work in concert to allow for a deeper or more intense exploration of the trauma-related events and/or their effects on relationships and other aspects of the participant's life.

Participant: "Fear is the only emotion I've ever really known that well ... afraid of this, afraid of that. That's all I remember feeling for as far as I can remember. Heart stopping, gut-wrenching fear."

Therapist: Hmmm (long silence/soft piano music)

Participant: "I've kept all this inside for so long. It feels so heavy, these emotions ... it's like I was trained this way ever since I can remember. Children were to be seen and not heard. From that point on I sought to make myself as insignificant as possible. Then after the rape happened, I was headline news. I knew everyone at the hospital. I was ashamed, like I had a scarlet letter."

Therapist: "I think experiencing these feelings of fear and shame are important for you."

Therapist: "You've been holding one to these emotions for so long and the belief that you have to be a certain way. It is a really powerful thing to feel, just the realization of it."

Participant: "And it all ties into how I handled my adult relationships, cuz I was always afraid to be myself because nobody would like me as myself. Then Tom comes along and I don't have to be a certain way. Now I have someone I can lean on and somebody that is there for me and doesn't judge me. It's a great feeling."

An MDMA-induced increased sense of closeness to others, trust, and intimacy may foster feelings of empathy and forgiveness for the self and others that may lead the participant to feel worthy despite the shame or distress caused by the traumatic event or events. Participant: "I felt that interconnection between me and Tom. I haven't felt it for a long time and that's what makes me feel so much better, knowing that it is still there. It's been a big stressor for me."

In addition, changes in feelings of closeness to others may allow for enhanced rapport between therapists and participant. While participants are directed to focus on their inner experience during much of the MDMA session, enhanced interpersonal trust and feelings of closeness to others may make it easier for the participant to convey his/ her inner experience to the therapists. Greater rapport during the MDMA-assisted session may also increase compliance with instructions provided by the therapists that are intended to improve the therapeutic experience or to reduce avoidance of fully experiencing a particular element of the experience, such as a memory, insight or feeling.

Participant: "It sucks to just live. Y'all are really a god send. It is so nice to have someone who understands. For so long it's been take this pill, take that pill. The night that I was raped, the first thing that popped into my mind was they are not going to believe me because of the T-shirt I was wearing. I really though nobody would believe me. And here you are. Just throughout the years, everyone said take this and take that. Nobody's really bothered to dig down to the symptoms and help me figure out what's causing this."

The therapists will engage in listening to and talking with the participant. Additionally, the therapists make judgments about when verbal interaction with the participant is indicated and when verbal interaction is an attempt by the participant to defend against difficult or painful emotional material. The therapists listen for cues that alert them to the participant's intellectualizing which may indicate that the participant needs to allow his/her experience additional time to unfold within. This is sometimes referred to as the participant "getting ahead of the internal emotional experience." In this situation, it is necessary for the therapists to intervene and guide the participant back to his/her internal experience.

Therapist: "It may be helpful to really get into a comfortable position and allow your body to sink into the mattress."

Participant: "I feel so crooked. Are you going to be able to walk me through any of the traumatic experiences to kind of help me focus?"

Therapist: "Absolutely. If it feels like it's the time to do that now, we can help you do that, but it might be better at this point to go inside and relax." (This response was based on the therapist's sense that the participant was trying to force the experience and was looking for outer direction at the expense of inner awareness.)

Participant: "I feel really restless."

Therapist: "Just attempt to go with the flow with that energy for a little while."

Therapist: "I think you should lie down, sink into the mattress and let your body get comfortable with that movement if you need to. Try and let your breath take you through the confusion and let the medicine work as you breathe and take you through it." Patient: "If you don't mind, could you remind me to breathe into it? Just give me a little sign to breathe."

Therapist: "How about if I just touch your shoulder to remind you. Remember the words, `Don't get ahead of the medicine. Let the medicine take you where you need to go."

It is essential for the therapists to recognize and work with both the participant's underlying psychological processes and the experience produced by the medicine. Working with both of these components of the experience involves simultaneously supporting the participant in experiencing the negative effects of the trauma and experiencing the softening effects of MDMA. The therapists' presence and the effects of the medicine provide a feeling of safety as the participant's barriers to perception open to allow increased access to memories, thoughts and emotions.

Participant: "Sometimes I am so detached from my family. Sometimes I don't even feel like my Aileen's mom. There's just not that ... I don't know."

Therapist: "Your derealization takes all of your attention."

Participant: "My perception is off."

Therapist: "This is a safe time to notice your own experience more. To focus on your experience rather than have it outer directed or having to just make it through. It appears to be unfolding today that there are these layers connected not only with the rape, but the experiences before. First, the top layer is the depersonalization when that veil came down, then there is self-pride and under there is fear and anger. It is finally safe to revisit that."

Participant: Breathing softly.

The therapists continually create a safe space for the participant as he or she experiences increased access to memories or thoughts. The medicine may also produce in some participants a feeling of loss of control. The therapists must be prepared to work with the participant to embrace these feelings and move through them as the participant is encouraged to surrender control and open to inner emotions which may previously have been too fearful to encounter.

The increase in sensitivity to interpersonal relationships and intimacy issues may draw participants to consider ways in which their symptoms have altered or impaired their relationships with others. These MDMA effects may better equip participants to view their interpersonal relationships, including relationship difficulties, without judging themselves or others too harshly.

Participant: "Did you tell Tom that I love him?"

Therapist: "No. Sorry I missed that but I can call him back. Is that something you are experiencing deeply now?"

Participant: "Yes, on a deep level, a deep feeling for all the love and understanding what I am going through and not knowing how to help. He's my soul-mate. I don't know what I`d do without him. That deep love I feel right now. I haven't felt that for so long."

The increased focus on interpersonal relationships may assist participants who have distanced themselves from others as a way of coping with the trauma or PTSD symptoms. Feelings of interpersonal trust may also assist participants who have dealt with or are dealing with a lack of support from significant others after the traumatic event or events. The therapists and participant might explicitly seek to explore these areas during part of the MDMA session.

During the MDMA session, the participant may experience strong negative emotional reactions, including a feeling of loss of control. When the therapists become aware of the participant's distress, they intervene, encouraging the participant to stay with deeper levels of emotion, and to trust that it is safe to face the experience. This may take the form of introducing the previously practiced breathing exercises, (e.g., "use your breath to stay with the experience, breathe into it"), verbal statements assuring the participant that he/she is in a safe place, orienting the participant to the "here and now", encouraging the participant to talk about his/her emotions, holding the participant's hand, or providing other nurturing touch. In this way, the therapists help the participant to stay with and move through his/her emotional experience, (i.e., the patient stays with the fear, anxiety, shame, guilt, etc), and acknowledge this as a natural progression of the therapeutic process. At this point in the session, the therapists and participant may engage in some level of bodywork. Bodywork in MDMA-assisted psychotherapy will be addressed in more detail in the Integrative Follow-up Sessions and New Intentions for Daily Living section.

An example of helping the participant with a difficult experience:

Participant: (deep breaths) "Fear."

Therapist: "Fear. Where do you feel it in your body?"

Participant: "In my chest. It's hard to breathe, kind of a suffocating kind of fear."

Therapist: "Any images or content associated with it?"

Participant: "No, just deep seated fear. Just that wrong feeling. It's just wrong. I don't know how to explain it. It's like that `take the wind out of your sails ... that overwhelming suffocating fear, terror, just out of control helpless fear." (Crying)

Therapist: "I would understand this is something you've been carrying around and it is now coming up to be expressed and for healing."

Participant: "It's weird. My body, I know I'm safe, but my mind just doesn't want to know it. It's a weird combination of my mind is telling my body one thing and my body is going `NO' but my mind is just that, just that ... it's like someone is throwing a wet blanket on me. It's just that suffocating; you know you can't catch your breath ... just fear."

Therapist: "Remember your breathing. We are right here with you. "

As the participant makes the transition from the non-ordinary state of consciousness into an ordinary state of consciousness, the therapists may communicate with the participant more extensively about what she or he experienced during the session. The therapists ask the participant if they are ready and would like to give more detailed feedback on his/her emotional and psychosomatic status (Grof, 2001). However, there should be no pressure to do so at this point and much of this may be left for follow-up sessions.

Therapist: "There is no pressure to talk now, but we might want to give you the opportunity to share more detail if that feels right. Sometimes people have the sense that it is best to hold the experience in silence until the next day and others find it useful to talk about it at this point."

The therapist will encourage the participant to reflect upon and accept the experience, and to consider any newly experienced insights. If the participant indicates awareness of physical pain, tension, anxiety, or other manifestations of distress, the therapist may use this as an entry for bodywork, a method of psychotherapy involving manual therapy. In preparation for bodywork the participant should be asked to use the word "stop" if there is ever any touch he or she does not want. He or she should be told that this command will always be obeyed by the therapists unless what they are doing is necessary to protect the subject from physical harm. This will avoid confusion between communications that are meant to be directed to the therapists and things the subject may say that are part of his or her inner experience.

When and if necessary, the therapists will take measures to assist a participant experiencing such a degree of emotional distress that they are not able to process and move through spontaneously. In most cases, these steps should be taken sequentially, proceeding to the next step only if necessary:

1. Ask, "What are you aware of in your body?" This will help the participant become conscious of the link between distressing emotions and any somatic manifestations. Making this link and making the suggestion to, "Breathe into that area and allow your experience to unfold", may be the only intervention that is needed at that point.
2. Encourage the participant to "Use your breath to help you stay as present as you can with this experience. Go inside to allow your inner healing intelligence to work with this." If it is during the MDMA session add, "The medicine will help that to happen."
3. If the participant is quite anxious (anxious affect, moving on the futon, opening eyes) it may be helpful to hold his or her hand, or for the therapist to put a hand gently on the participants arm, chest or back, or on an area where he or she is experiencing pain, tension or other physical symptoms. This can be reassuring and help refocus attention on inner experience. This should only be done with the participant's permission.
4. If this does not lead to resolution of the distress, ask, "Is there content (specific images, memories or thoughts) that's coming up with these feelings?" If so, the therapists may wish to speak to the participants about it. The opportunity to put the experience into words may in itself be therapeutic, especially in this safe setting, working with the tendency of the MDMA to decrease critical self- statements, fear and to increase trust. This will also be an opportunity for the therapists to help the participant explore connections between current symptoms and past traumatic experiences, and to put these experiences into perspective in his/her current life.
5. After this period of talking, and periodically throughout the session, encourage the participant to "go back inside", to focus on his/her own inner experience.
6. If the participant continues to express or exhibit emotional distress or somatic tension or pain, bodywork of a more focused nature may be indicated. This is discussed in detail in Appendix A.

As the MDMA session draws to a close, the participant has the option of inviting a significant other into the consultation room to assist with re-entry and join the participant in his/her recovery process. The participant and therapists will share information about the participant's present condition with the chosen individual, and the therapists will encourage the significant other to share any concerns or questions he/she may have. The therapists may educate the significant other about the after-effects of the MDMA experience and together the group may discuss what might be expected over the course of time as the healing process unfolds. The participant remains overnight in the treatment setting, accompanied by a trained attendant, and the participant may be given the option for his/her significant other to stay as well. Both the participant and significant other (with the participant's permission) will be given a means to contact the therapists. The therapists will be available to speak with the participant during this time and they will be able to rapidly return to the clinic if requested to do so by the participant or the attendant. The therapists will examine physiological measures (blood pressure, pulse, and temperature) and self-reported distress and mental state to reach a clinical judgment concerning the participant's stability and the strength of drug effects. When the drug effects are no longer apparent and the participant is judged to be stable, the therapists will leave the clinic.

After the therapists leave (when they have judged the patient to be emotionally and medically stable), the participant will spend the rest of the evening and night in the clinic or offices of the therapists, where he or she will have a private room to sleep in. The room will be an office designated for that purpose and will be furnished with comfortable furniture and a sofa-bed. The attendant will be on duty during this time and will have a separate room in which to rest. As is true for the current study, any place where MDMA- assisted therapy is performed should be equipped with rooms that can house the patient, an attendant, and a selected significant other. A kitchen and eating space should also be available.

The presence of the attendant may assist the participant in further approaching and considering the material from the MDMA session by acting as an impartial and empathic listener. The attendant will also serve as a supportive caretaker and will monitor the mental and physical state of the subject. The attendant will contact the therapists if at any time the participant appears to be in distress or is experiencing any problem.

The participant may spend his or her time indoors or outdoors, so long as the attendant is nearby. However, the participant will be encouraged to use much of the time for rest and for a period of reflection and integration in a quiet atmosphere. The participant may also spend time with the selected friend, family member, partner or spouse as mentioned earlier.

A follow-up session will occur on the morning following each MDMA session. The attendant is instructed to page the therapists in the event the patient may need something throughout the night.