A Test of MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT00090064
First received: August 24, 2004
Last updated: November 12, 2015
Last verified: February 2014
  Purpose
This study is being conducted to find out if methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is safe and can help people with posttraumatic stress disorder (PTSD) arising from being a victim of a crime.

Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: 3,4-methylenedioxymethamphetamine (MDMA)
Drug: lactose (placebo
Behavioral: Psychotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Multidisciplinary Association for Psychedelic Studies:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Screening, baseline, four days after experimental session 1, four days after experimental session 2, 2 months after experimental session 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptoms, measured via Impact of Events Scale (IES) [ Time Frame: Baseline, four days after experimental session 1, four days after experimental session 2, two months after experimental session 2 ] [ Designated as safety issue: No ]
  • PTSD symptoms through Symptom Checklist 90-R. (SCL-90-R) [ Time Frame: Baseline, four days after experimental session 1, four days after experimental session 2, two months after experimental session 2 ] [ Designated as safety issue: No ]
  • Problem solving, Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Baseline, two months after experimental session 2 ] [ Designated as safety issue: Yes ]
  • Rey-Osterrieth Complex Figure Test [ Time Frame: Baseline, two months after experimental session 2 ] [ Designated as safety issue: Yes ]
  • Psychological distress, Subjective Units of Distress (SUDS) [ Time Frame: every sixty to ninety minutes throughout each experimental or open-label session ] [ Designated as safety issue: Yes ]
  • Cognitive function, Repeatable Battery for Assessment of Neuropsychological Status [ Time Frame: Baseline, two months after experimental session 2 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: March 2004
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during course of each of two day-long psychotherapy sessions plus a third open-label MDMA-assisted session.
Drug: 3,4-methylenedioxymethamphetamine (MDMA)
125 mg and 62.5 mg MDMA
Behavioral: Psychotherapy
Psychotherapy provided by a team of two co-therapists
Placebo Comparator: 2
Participants will receive an initial dose of placebo orally followed 2 to 2.5 hours later by a second dose of placebo during the course of each of two experimental sessions.
Drug: lactose (placebo
two capsules placebo matched in weight with MDMA capsules
Behavioral: Psychotherapy
Psychotherapy provided by a team of two co-therapists

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be diagnosed with chronic PTSD, duration of 5 years or longer resulting from traumatic experience during military service or a victim of crime;
  • Have a CAPS score showing moderate to severe PTSD symptoms;

    1. 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.
    2. 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 50 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090064

Locations
United States, South Carolina
Offices of Michael Mithoefer MD
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Michael Mithoefer, MD Private practice
  More Information

Additional Information:
Publications:
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT00090064     History of Changes
Other Study ID Numbers: 63,384 
Study First Received: August 24, 2004
Last Updated: November 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
Methylenedioxymethamphetamine
PTSD
psychotherapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Agents
Hallucinogens
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 10, 2016