Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

Brief Summary

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetamine 125 mg
  • Drug: 3,4-methyelendioxymethamphetamine 25 mg
  • Behavioral: Psychotherapy
  • Drug: 3,4-methylenedioxymethamphetamine (125 mg)
  • Drug: 3,4-methyelendioxymethamphetamine (25 mg)
  • 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: 14 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Oct 01, 2006
Primary Completion: Feb 01, 2011
Completion Date: Feb 01, 2011
Study First Posted: Jul 19, 2006
Results First Posted: Sep 16, 2021
Last Updated: Mar 14, 2022

Sponsors / Collaborators

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

Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering.

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participants will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session. People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session.

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT00353938
Other IDs: M-P2
Study URL: https://ClinicalTrials.gov/show/NCT00353938
Last updated: Jun 16, 2022