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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
Results First Posted : October 25, 2021
Last Update Posted : November 26, 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
Results First Submitted Date  ICMJE August 25, 2021
Results First Posted Date  ICMJE October 25, 2021
Last Update Posted Date November 26, 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: October 22, 2021)
  • Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) [ Time Frame: Less than 4 weeks before first experimental session ]
    The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
  • Primary Endpoint Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) [ Time Frame: 2 months after second experimental session ]
    The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
  • Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up [ Time Frame: Baseline to 2 months post second experimental session ]
    The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
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: October 22, 2021)
  • Baseline Impact of Events Scale Revised (IES-R) [ Time Frame: Baseline (less than 4 weeks before first experimental session) ]
    The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
  • Primary Endpoint Impact of Events Scale Revised (IES-R) [ Time Frame: 2 months after second experimental session ]
    The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
  • Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up [ Time Frame: Baseline to 2 months post second experimental session ]
    The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
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 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 randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo.
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.

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. Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted psychotherapy may benefit people with PTSD.

This randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo. Psychotherapists and independent raters were blinded to participants' treatment conditions. This treatment period also consisted of preparatory sessions and several non-drug therapy sessions to facilitate integration of material arising during experimental sessions.

During Stage 2 of the study, the blind was broken and participants assigned to receive MDMA in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy. Participants assigned placebo during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome measures were administered two months after the second MDMA or placebo session in Stage 1 and four to six weeks after the second MDMA session in Stage 2. A final data-collection session took place at two months after the third experimental session.

The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving the placebo vs. full dose of MDMA-assisted psychotherapy.

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
    125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA
    Other Name: MDMA
  • Drug: Lactose placebo pill
    125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo
    Other Name: Placebo
  • Behavioral: Therapy
    Non-directive therapy provided by a team of two co-therapists
Study Arms  ICMJE
  • Experimental: MDMA-assisted therapy
    Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
    Interventions:
    • Drug: 3,4-methylenedioxymethamphetamine
    • Behavioral: Therapy
  • Placebo Comparator: Placebo with therapy
    Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Interventions:
    • Drug: Lactose placebo pill
    • Behavioral: Therapy
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
Current Responsible Party Multidisciplinary Association for Psychedelic Studies
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Mithoefer, MD Private Practice
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date November 2021

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