Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

Criteria

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.