Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090064
Recruitment Status : Completed
First Posted : August 25, 2004
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE August 24, 2004
First Posted Date  ICMJE August 25, 2004
Last Update Posted Date June 8, 2021
Study Start Date  ICMJE March 2004
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Improvement in PTSD symptoms, measured by CAPS score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2008)
  • 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 ]
  • 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 ]
  • Problem solving, Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Baseline, two months after experimental session 2 ]
  • Rey-Osterrieth Complex Figure Test [ Time Frame: Baseline, two months after experimental session 2 ]
  • Psychological distress, Subjective Units of Distress (SUDS) [ Time Frame: every sixty to ninety minutes throughout each experimental or open-label session ]
  • Cognitive function, Repeatable Battery for Assessment of Neuropsychological Status [ Time Frame: Baseline, two months after experimental session 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Improvement in PTSD symptoms as assessed through other measures
  • No impairment in tests of attention, memory or problem-solving
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Test of MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Official Title  ICMJE Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
Brief Summary 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.
Detailed Description

Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. It is most likely to occur following an event involving perceived personal threat, such as rape or physical assault. PTSD is clearly a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs. This study will examine whether two sessions of methylenedioxymethamphetamine (MDMA)-assisted psychotherapy can be safely administered to participants with PTSD, and whether MDMA-assisted psychotherapy, when compared with placebo-assisted therapy, will reduce PTSD symptoms after each session and two months after the second session.

MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Currently, MDMA is scheduled (illegal) and cannot be used outside of research studies like this one. Anecdotal reports of therapy conducted before MDMA was made illegal suggest that MDMA-assisted psychotherapy may benefit people with PTSD.

This study will examine MDMA-assisted psychotherapy in twenty people ages 18 to 70 with PTSD either related to crime victimization or combat, when combat-related PTSD lasts no longer than five years, and that has not gotten better after psychotherapy and treatment with an SSRI (selective serotonin uptake inhibitor, such as Paxil).

This study lasts three to four months. Participants attend up to fourteen (14) ordinary (non-drug) psychotherapy sessions with the investigators as well as two eight hour long experimental (MDMA or placebo) sessions and one MDMA session. People taking part in this study cannot take any psychiatric medication during the study period. People will either get 125 mg MDMA or placebo "by chance," as by coin-toss, with twelve of twenty (60%) getting MDMA during each experimental session, and eight of twenty (40%) getting placebo. Two to two and a half hours later, if you and the investigators agree it is alright, you will take a second supplemental, dose of MDMA or placebo. The supplemental dose will be half the size of the first dose. The same investigators conducting non-drug therapy sessions conduct the experimental sessions. All participants are required to stay the night at the clinic after each experimental session. Participants meet with the investigators for a non-drug assisted therapy session the day after each experimental session. A third MDMA session in this placebo-controlled stage of the study will only be for people who received MDMA in the first two sessions.

PTSD symptoms are measured at the start of the study, four days after each experimental session, and finally two months after the second experimental session. People are tested on memory and problem solving when they first enter the study and again two months after the second experimental session. PTSD symptoms are measured to see whether there are any changes in symptoms during the study, and tests of thinking, memory and problem-solving are meant to spot any changes that could be due to MDMA or MDMA-assisted therapy.

Participants who recieved MDMA who complete the final evaluation, and upon discussion with the investigators, will undergo a third MDMA session. The third session will happen approximately two months after the second experimental session This session is "open label," meaning that they and the investigators will both know they are receiving MDMA. It will be followed by one psychotherapy session a day after this session and two additional psychotherapy sessions in the following weeks. PTSD symptoms will be measured again two months after the third MDMA session.

Participants who received placebo and complete the final evaluation two months after the second experimental procedure will be given an opportunity to take part in an open-label continuation of the study where they will receive an initial dose of 125 mg MDMA and a supplemental dose of 62.5 mg MDMA in up to three experimental sessions scheduled three to five weeks apart. Participants in this open-label continuation will act as their own controls. The open-label continuation lasts three months and will involve nine more visits with the investigators, including the two experimental sessions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE
  • Drug: 3,4-methylenedioxymethamphetamine (MDMA)
    125 mg and 62.5 mg MDMA
  • Drug: lactose (placebo
    two capsules placebo matched in weight with MDMA capsules
  • Behavioral: Psychotherapy
    Psychotherapy provided by a team of two co-therapists
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: 3,4-methylenedioxymethamphetamine (MDMA)
    • Behavioral: Psychotherapy
  • 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.
    Interventions:
    • Drug: lactose (placebo
    • Behavioral: Psychotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2014)
23
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
20
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00090064
Other Study ID Numbers  ICMJE MP1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Mithoefer, MD Private Practice
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP