Additional MDMA-assisted Psychotherapy for People Who Relapsed After MDMA-assisted Psychotherapy Trial
This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.
Detailed Description
Open-label, single-group Phase II study of a single full-dose MDMA-assisted therapy session (125 mg followed by 62.5 mg 1.5–2.5 hours later) for up to three participants with relapsed PTSD after prior MDMA-assisted therapy.
Participants receive one preparatory therapy session, the MDMA session with overnight clinic stay and monitoring of vital signs and psychological distress, and three post-session integrative therapy sessions; outcomes assessed at baseline, 2 months and 12 months.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted therapy
experimentalSingle full-dose MDMA-assisted therapy session with preparatory and integrative non-drug therapy sessions.
Interventions
- MDMA125 mgvia Oral• single session• 2 doses total
Second dose 62.5 mg given 1.5–2.5 hours after initial 125 mg.
Participants
Inclusion Criteria
- Be diagnosed with chronic PTSD.
- Have a CAPS score showing moderate to severe PTSD symptoms.
- Have participated in MP-1.
- Are at least 18 years old.
- Must be generally healthy.
- Must sign a medical release for the investigators to communicate directly with their therapist and doctors.
- Are willing to refrain from taking any psychiatric medications during the study period.
- Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session.
- Willing to remain overnight at the study site.
- Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session.
- Are willing to be contacted via telephone for all necessary telephone contacts.
- Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control.
- Must provide a contact in the event of a participant becoming suicidal.
- Are proficient in speaking and reading English.
- Agree to have all clinic visit sessions recorded to audio and video.
- Agree not to participate in any other interventional clinical trials during the duration of this study.
Exclusion Criteria
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control.
- Weigh less than 48 kg.
- Are abusing illegal drugs.
- Are 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.