Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

• Status: Terminated
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This small ("pilot") study is designed to provide information on whether the combination of psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress disorder (PTSD). The researchers will use the results of this study to design more studies of this treatment. The study compares a comparator (placebo) and a full dose. For each session, there will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the size of the initial dose. The study will measure symptoms of PTSD, depression, general psychological well-being, sleep quality, feelings that the self or world is unreal (dissociation), potentially positive effects of surviving traumatic events and cognitive function (thinking, memory and attention). People experiencing pain or tinnitus (ringing in the ears) will record their symptoms throughout the study. Seven people will be randomly (by chance) assigned to receive full-dose MDMA and five will be randomly assigned to receive a comparator. There will be three preparatory psychotherapy sessions before the first experimental session, and subjects will have supportive or "integrative" sessions after each MDMA-assisted psychotherapy session. Subjects will meet with a male and female psychotherapist for all experimental sessions and for sessions before and after each experimental session. Subjects who received comparator can enroll in Stage 2, where they will have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know they are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have a third experimental session.. Symptoms of PTSD and other symptoms will be measured again at least 12 months after each subject has started the study.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosed with PTSD, duration of six months or longer

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

• 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.

• 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