MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo.

• 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, duration of 5 years or longer resulting from traumatic experience during military service or a victim of crime;

• Have a CAPS score showing moderate to severe PTSD symptoms;

1. Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.

2. 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 50 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