Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2 pilot study assessed the safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects were enrolled in the open label full dose lead-in with 125 mg of MDMA, followed 1.5 to 2.5 hours later by a supplemental half-dose of 62.5 mg of MDMA. The remaining eight subjects enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25 mg MDMA, with a supplemental dose of 12.5 mg MDMA) or a fully active dose of MDMA (125 mg, with a supplemental dose of 62.5 mg MDMA) during two experimental psychotherapy session, each lasting six to eight hours and scheduled three to five weeks apart. The extent of PTSD symptoms was assessed at baseline and two months after the second experimental session using the Clinician Administered PTSD Scale (CAPS) [Blake et al., 1995]. Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study and complete open-label experimental sessions with the fully active dose of MDMA on the same schedule as Stage 1.

• 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 chronic PTSD with a duration of 6 months or longer.

• Have a CAPS score showing moderate to severe symptoms.

• Had at least one unsuccessful attempt at treatment for PTSD, either with talk therapy or with drugs, or stopped treatment because of inability to tolerate psychotherapy or drug therapy.

• Are at least 18 years old.

• 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.

• Agree that, one week before the MDMA session, will refrain from taking all below unless with prior approval of research team: herbal supplements, nonprescription medications (with the exception of nonsteroidal anti-inflammatory drugs or acetaminophen, any prescription medications, with the exception of birth control pills, thyroid hormone, or other medications;

• Are willing to follow restrictions and guidelines concerning consumption of food, beverages. and nicotine the night before and just prior to each experimental session.

• Are willing to remain overnight at the study site.

• 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.

• Agree not to participate in any other clinical trial for the duration of this clinical trial, including the follow-up period.

• Are proficient in speaking and reading Hebrew.

• Agree to have all psychotherapy sessions recorded to audio/video.

Exclusion Criteria:

• Are pregnant or nursing, or if they can have children and 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.