Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life. This Phase 2 pilot study examined the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant posttraumatic stress disorder (PTSD). This study is part of a global series of Phase 2 pilot clinical trials. This randomized, double-blind, dose response study assessed two active doses of MDMA, 100 mg and 125 mg, to a comparator dose of MDMA (40 mg) during psychotherapy sessions. The initial dose was followed 1.5 to 2.5 hours later by an optional supplemental dose of MDMA that was half the size of the first dose. MDMA was administered in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart. Subjects were prepared for MDMA-assisted psychotherapy prior to the first session in three preparatory sessions, and worked with the same pair of therapists throughout the study. After each MDMA-assisted psychotherapy session, subjects had three integrative sessions with their therapist team to process and understand their experience.

This study assessed the change in symptoms of PTSD, as measured by the Clinical Administered PTSD Scale (CAPS) [Blake et al., 1995], as well as symptoms of depression, as measured by the Beck Depression Inventory II (BDI-II) [Beck, A.T. and R.A, 1984; Beck, A.T., et al., 1996] from baseline enrollment to one month after the second MDMA-assisted psychotherapy session (primary endpoint).

Participants who received the comparator dose of MDMA (40 mg) were given the option to enroll in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions with an active dose of MDMA. People who received either of the active doses of MDMA in Stage 1 had a third MDMA-assisted psychotherapy session with another active dose of MDMA.

• 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 for six months or longer.

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

• 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.

• Are willing to refrain from taking any psychiatric medications during the study period.

• Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA session.

• Willing to remain overnight at the study site.

• Are willing to be driven home after experimental sessions either by a driver they arrange, a taxi, or study personnel.

• Are willing to be contacted via telephone by study personnel.

• If of child-bearing age, must have a negative pregnancy and agree to use an effective form of birth control.

• Must provide a personal contact who is willing to be reached in case of emergency.

• Agree to let the investigators know within 48 hours of any planned medical interventions.

• Are proficient in reading and speaking English.

• Agree to have all psychotherapy sessions recorded.

• Agree not to participate in any other interventional clinical trials during the course of the study.

Exclusion Criteria:

• Are pregnant or nursing, or if of child-bearing age and do not use 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.