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

This study has been completed.
Sponsor:
Information provided by:
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT00090064
First received: August 24, 2004
Last updated: February 18, 2014
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:

  • Diagnosed with PTSD as a result of crime victimization or as a result of combat if symptoms have lasted for no longer than five years.
  • Very little or no improvement in PTSD signs or symptoms after three months' treatment with a selective serotonin uptake inhibitor (SSRI) and little or no improvement after six months' treatment with any form of psychotherapy for which there there is evidence from a controlled trial that this type of therapy efficacious (good for treating) PTSD.
  • Must be willing to attend all sessions, and to take MDMA or placebo.
  • If you are seeing another psychotherapist, you must be willing to give the principal investigator permission to communicate with him or her.
  • Must be willing to stop taking any psychiatric medications during the study period. Drugs will be tapered in an appropriate fashion to avoid withdrawal effects. Participants must not start any new medications until after the evaluation session, which will occur 2 months after the second experimental session.
  • Must be willing to remain overnight at the clinic after each experimental session until the non-drug session occurring the next morning. An attendant will be present to assist with personal needs if requested and offer dinner and breakfast. The attendant will be a registered nurse (RN) and of the same sex as the participant, and he or she will be trained for assisting in this study.
  • Participants must be willing to be contacted via telephone on a daily basis by one of the investigators for a week after each experimental session.
  • Female participants of childbearing potential must have a negative pregnancy test and must agree to use an effective form of birth control.
  • Participants must be literate. They must be proficient in reading documents written in English.

Exclusion Criteria:

  • People with a non-crime or non-war related traumatic event that makes a significant contributor to their PTSD symptoms, as assessed by the CAPS.
  • Women who are pregnant or nursing, or who are able to get pregnant and are not practicing an effective means of birth control.
  • People with a history of or current primary psychotic disorder or bipolar affective disorder type 1.
  • People with dissociative identity disorder or an eating disorder with active purging, or borderline personality disorder.
  • People with hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
  • People with evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (Participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
  • Weighing less than 50 kg (110 lb) or more than 105 kg (230 lb).
  • People who reported they used "Ecstasy" (material represented as MDMA) more than 5 times or at any time within the previous 6 months.
  • People who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.
  • People requiring ongoing concomitant therapy with a psychotropic drug.
  • People diagnosed with substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.
  • Any person who is not able to give adequate informed consent.
  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: Rick Doblin, PhD, Multidisciplinary Association for Psychedelic Studies (MAPS)
ClinicalTrials.gov Identifier: NCT00090064     History of Changes
Other Study ID Numbers: 63,384
Study First Received: August 24, 2004
Last Updated: February 18, 2014
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
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014