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

MDMA

Brief 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.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetmine (MDMA)
  • Behavioral: Psychotherapy
  • Behavioral: Therapy

Condition or Disease

  • Posttraumatic Stress Disorder

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: Has Results
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 3 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Nov 01, 2011
Primary Completion: May 01, 2015
Completion Date: Mar 01, 2016
Study First Posted: Oct 24, 2011
Results First Posted: Nov 03, 2021
Last Updated: Nov 03, 2021

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Mount Pleasant, South Carolina, USA

This study will investigate the effects of an additional 3,4-methylenedioxymethamine (MDMA)-assisted therapy session in up to three participants with PTSD who relapsed after their PTSD symptoms had significantly decreased during MAPS' initial U.S. Phase 2 trial testing the use of MDMA-assisted therapy in subjects with chronic, treatment-resistant posttraumatic stress disorder PTSD). This new protocol will consist of a single, full-dose open-label session of MDMA-assisted therapy, along with associated non-drug preparation and integrative therapy sessions.

MDMA is an investigational drug that was studied in a randomized, placebo-controlled study in 21 participants, and it included a final evaluation of symptoms at least one year after taking part in the study. While PTSD symptoms in most study subjects stayed at the same levels from when they completed the study, symptoms had returned in a few people. This open-label study is intended to see if an additional MDMA-assisted session conducted at least 14 months after the first sessions can help reduce PTSD symptoms.

The MDMA-assisted therapy session will be conducted by a male and female co-therapist team, one a psychiatrist and the other a psychiatric nurse. Vital signs (blood pressure, pulse and body temperature) and psychological distress will be measured throughout the experimental session. After the experimental session they will spend the night in the clinic with an attendant on duty, and complete a measure of alterations in consciousness, the States of Consciousness Questionnaire (SCQ) on the evening or day following the experimental session. Participants will meet with the investigators the next morning for an integrative therapy session before leaving the clinic. During integrative therapy sessions they will receive support in integrating their experiences and insights from the MDMA-assisted therapy session. There will be daily phone contact with one of the investigators for 7 days after the experimental session. Symptoms of PTSD, depression and general function will be assessed two months after the experimental session. There will be a long-term follow up with repeated outcome measures 12 months after the experimental session

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT01458327
Other IDs: MP1-E2
Study URL: https://ClinicalTrials.gov/show/NCT01458327
Last updated: Jun 17, 2022