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Randomized, Double-blind, Active-placebo Controlled Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

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ClinicalTrials.gov Identifier: NCT01689740
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Brief Summary:
This study will examine symptoms of posttraumatic stress disorder (PTSD) in people before and after psychotherapy with 25 mg followed two hours later by 12.5 mg or 125 mg followed two hours later by 62.5 mg methylenedioxymethamphetamine (MDMA) in order to see if this treatment is safe and can help reduce PTSD symptoms. Participants will be randomly assigned to one of the two doses of MDMA given in two sessions scheduled three to five weeks apart. They will prepare for the sessions before the first one and they will work with psychotherapists in conventional (non-drug assisted) psychotherapy afterwards. Symptoms of PTSD and depression, sleep quality and general psychological health will be measured at the start of the study and 2 and 12 months after the second session.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Drug: Active placebo dose MDMA Drug: Full dose MDMA Drug: 125 mg MDMA (open label) Behavioral: Psychotherapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Study Start Date : October 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lead in: 125 mg MDMA (Open Label) and psychotherapy
Open label: Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Drug: 125 mg MDMA (open label)
Initial dose of MDMA administered orally at the start of each of two psychotherapy sessions, supplement administered 1.5 go 2.5 hours later.

Behavioral: Psychotherapy
Psychotherapy provided throughout course of main study

Placebo Comparator: Active placebo dose MDMA and psychotherapy
Participants receive initial doses of 25 mg MDMA during each of two experimental sessions.
Drug: Active placebo dose MDMA
Initial dose of 25 mg MDMA administered orally at the start of each of two separate psychotherapy sessions scheduled three to five weeks apart possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.

Behavioral: Psychotherapy
Psychotherapy provided throughout course of main study

Experimental: Full dose MDMA and psychotherapy
Participant will receive full dose MDMA (125 mg NDMA( during two separate psychotherapy sessions.
Drug: Full dose MDMA
Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions scheduled three to five weeks apart. In each case, it may be followed 1.5 to 2.5 hours later with 62.5 mg MDMA.

Behavioral: Psychotherapy
Psychotherapy provided throughout course of main study




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: 14-19 weeks post enrollment) ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales

  2. Clinician Administered PTSD Scale (CAPS) [ Time Frame: 0 weeks post-enrollment ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales


Secondary Outcome Measures :
  1. Clinician-Administered PTSD Scale [ Time Frame: 24 to 35 weeks post-enrollment ]
    Clinician administered and scored assessment of PTSD symptoms

  2. Clinician-Administered PTSD Scale [ Time Frame: Up to 64 weeks post-enrollment ]
    Clinician administered and scored assessment of PTSD symptoms

  3. Beck Depression Inventory - II [ Time Frame: 14-19 weeks post-enrollment ]
    Established self-report measure of symptoms of depression

  4. Beck Depression Inventory - II [ Time Frame: 0 weeks post-enrollment ]
    Established self-report measure of symptoms of depression

  5. Beck Depression Inventory - II [ Time Frame: 24 to 35 weeks post-enrollment ]
    Established self-report measure of symptoms of depression

  6. Beck Depression Inventory - II [ Time Frame: Up to 64 weeks post-enrollment ]
    Established self-report measure of symptoms of depression

  7. Global Assessment of Functioning (GAF) [ Time Frame: 14-19 weeks post-enrollment ]
    Clinician-scored assessment of general psychological well-being, range 1-100

  8. Global Assessment of Functioning (GAF) [ Time Frame: 0 week post-enrollment ]
    Clinician-scored assessment of general psychological well-being, range 1-100

  9. Global Assessment of Functioning (GAF) [ Time Frame: 24 to 35 weeks post-enrollment ]
    Clinician-scored assessment of general psychological well-being, range 1-100

  10. Global Assessment of Functioning (GAF) [ Time Frame: Up to 64 weeks post-enrollment ]
    Clinician-scored assessment of general psychological well-being, range 1-100

  11. Pittsburgh Sleep Quality Index [ Time Frame: 0 weeks post-enrollment ]
    Assesses self-reported sleep quality

  12. Pittsburgh Sleep Quality Index [ Time Frame: 14-19 weeks post-enrollment ]
    Assesses self-reported sleep quality

  13. Pittsburgh Sleep Quality Index [ Time Frame: Up to 64 weeks post-enrollment ]
    Assesses self-reported sleep quality

  14. Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 0 weeks post-enrollment ]
    Self-report measure of PTSD symptoms and diagnosis

  15. Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 5-8 weeks post-enrollment ]
    Self-report measure of PTSD symptoms and diagnosis

  16. Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 8-13 weeks post-enrollment ]
    Self-report measure of PTSD symptoms and diagnosis

  17. Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 14-19 weeks post-enrollment ]
    Self-report measure of PTSD symptoms and diagnosis

  18. Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Up to 64 weeks post-enrollment ]
    Self-report measure of PTSD symptoms and diagnosis

  19. Peak Systolic blood pressure [ Time Frame: 3-6 weeks post-enrollment: collected from measurements made every 30 min for 6-8 hours ]
    Systolic blood pressure will be periodically measured, and pre-drug, peak and endpoint values will be recorded

  20. Peak Systolic blood pressure [ Time Frame: 6-11 weeks post-enrollment: collected from measurements made every 30 min for 6-8 hours ]
    Systolic blood pressure will be periodically measured, and pre-drug, peak and endpoint values will be recorded

  21. Peak diastolic blood pressure [ Time Frame: 3-6 weeks post-enrollment: from measurements taken every 30 min for 6-8 hours ]
    Blood pressure will be periodically measured throughout the first experimental session

  22. Peak diastolic blood pressure [ Time Frame: 6-11 weeks post-enrollment: from measurements taken every 30 min for 6-8 hours ]
    Blood pressure will be periodically measured throughout the first experimental session

  23. Peak heart rate (HR) [ Time Frame: 3-6 weeks post enrollment; from measurements taken every 30 minutes for 6-8 hours ]
    Heart rate will be assessed by measuring pulse

  24. Peak heart rate (HR) [ Time Frame: 6-11 weeks post-enrollment: from measurements taken every 30 minutes for 6-8 hours ]
    Heart rate will be assessed by measuring pulse

  25. Peak body temperature [ Time Frame: 3-6 weeks post-enrollment; from measurements taken every 60-90 min throughout session ]
    Body temperature will be measured

  26. Peak body temperature [ Time Frame: 6-11 weeks post-enrollment; from measurements taken every 60-90 min throughout session ]
    Body temperature will be measured

  27. Peak subjective units of distress (SUD) [ Time Frame: 3-6 weeks post-enrollment; from measurements taken every 60-90 min throughout session ]
    Degree of psychological (subjective) distress will be assessed by asking participant to choose a number between 1 and 7

  28. Peak subjective units of distress (SUD) [ Time Frame: 6-11 weeks post-enrollment; from measurements taken every 60-90 min throughout session ]
    Degree of psychological (subjective) distress will be assessed by asking participant to choose a number between 1 and 7

  29. End-point systolic blood pressure [ Time Frame: 3-6 weeks post-enrollment; last measurement ]
    Blood pressure will be measured up up to 6 h postdrug or until drug effects wane

  30. End-point systolic blood pressure [ Time Frame: 6-11 weeks post-enrollment; last measurement ]
    Blood pressure will be measured up up to 6 h postdrug or until drug effects wane

  31. End-point diastolic blood pressure [ Time Frame: 3-6 weeks post-enrollment; last measurement ]
    Blood pressure will be measured up up to 6 h postdrug or until drug effects wane

  32. End-point diastolic blood pressure [ Time Frame: 6-11 weeks post-enrollment; last measurement ]
    Blood pressure will be measured up up to 6 h postdrug or until drug effects wane

  33. End-point heart rate (HR) [ Time Frame: 3-6 weeks post-enrollment; last measurement ]
    Heart rate will be measured by measuring pulse up up to 6 h postdrug or until drug effects wane

  34. End-point heart rate (HR) [ Time Frame: 6-11 weeks post-enrollment; last measurement ]
    Heart rate will be measured by measuring pulse up up to 6 h postdrug or until drug effects wane

  35. End-point body temperature [ Time Frame: 3-6 weeks post-enrollment; last measurement ]
    Body temperature will be measured up up to 6 h postdrug or until drug effects wane

  36. End-point body temperature [ Time Frame: 6-11 weeks post-enrollment; last measurement ]
    Body temperature will be measured up to 6 h postdrug or until drug effects wane

  37. End-point Subjective Units of Distress (SUD) [ Time Frame: 3-6 weeks post-enrollment; last measurement ]
    Psychological (subjective) distress will be measured up up to 6 h postdrug or until drug effects wane

  38. End-point Subjective Units of Distress (SUD) [ Time Frame: 6-11 weeks post-enrollment; last measurement ]
    Psychological (subjective) distress will be measured up up to 6 h postdrug or until drug effects wane

  39. Pre-drug systolic blood pressure [ Time Frame: 3-6 weeks post-enrollment; first measurement taken prior to drug administration ]
    Blood pressure will be measured at start of experimental session and thereafter every 30 min

  40. Pre-drug systolic blood pressure [ Time Frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration ]
    Blood pressure will be measured at start of experimental session and thereafter every 30 min

  41. Pre-drug diastolic blood pressure [ Time Frame: 3-6 weeks post-enrollment; first measurement taken prior to drug administration ]
    Blood pressure will be measured at start of experimental session and thereafter every 30 min

  42. Pre-drug diastolic blood pressure [ Time Frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration ]
    Blood pressure will be measured at start of experimental session and thereafter every 30 min

  43. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 0 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  44. Pre-drug heart rate [ Time Frame: 3-6 weeks post-enrollment: collected prior to drug administration ]
    Heart rate will be measured via pulse at start of experimental session and thereafter every 30 min

  45. Pre-drug heart rate [ Time Frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration ]
    Heart rate will be measured via pulse at start of experimental session and thereafter every 30 min

  46. Pre-drug body temperature [ Time Frame: 3-6 weeks post-enrollment; first measurement taken prior to drug administration ]
    Body temperature will be measured at the start of the experimental session and every 60 to 90 minutes afterwards

  47. Pre-drug body temperature [ Time Frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration ]
    Body temperature will be measured at the start of the experimental session and every 60 to 90 minutes afterwards

  48. Pre-drug Subjective Units of Distress (SUD) [ Time Frame: 3-6 weeks post-enrollment; last measurement ]
    Psychological (subjective) distress will be measured at the start of the study and for every 60 to 90 minutes afterwards

  49. Pre-drug Subjective Units of Distress (SUD) [ Time Frame: 6-11 weeks post-enrollment; last measurement ]
    Psychological (subjective) distress will be measured at the start of the study and for every 60 to 90 minutes afterwards

  50. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 2 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  51. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 3-6 weeks post-enrollment (session start/approx. 6 hours postdrug) ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  52. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 6-11 weeks post-enrollment (session start/approx. 6 hours postdrug) ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  53. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Up to 64 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  54. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 3 weeks +1 day to 6 weeks + 1 day post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  55. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 6 weeks +1 day to 11 weeks + 1 day post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  56. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 4-7 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  57. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 5-8 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  58. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 7-12 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  59. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 8-13 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  60. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 3 weeks +3 and 8 days to 6 weeks +3 and 8 days post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  61. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 6 weeks +3 and 8 days to 11 weeks +3 and 8 days post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses

  62. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 14-19 weeks post-enrollment ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject's responses



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with chronic PTSD with a duration of 6 months or longer;
  • Have a CAPS score showing moderate to severe symptoms
  • at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or stopping treatment because of inability to tolerate psychotherapy or drug therapy.
  • Are at least 18 years old
  • 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
  • agree that, one week before the MDMA session, will refrain from taking all below unless with prior approval of research team: herbal supplements, nonprescription medications (with the exception of nonsteroidal anti-inflammatory drugs or acetaminophen,any prescription medications, with the exception of birth control pills, thyroid hormone, or other medications;
  • Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session
  • are willing to remain overnight at the study site
  • 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;
  • Agree not to participate in any other clinical trial for the duration of this clinical trial, including the follow up period;
  • Are proficient in speaking and reading Hebrew;
  • Agree to have all psychotherapy sessions recorded to audio/video.

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 48 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689740


Locations
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Israel
Beer Yaakov Hospital
Be'er Ya'aqov, Israel, 70350
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
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Principal Investigator: Moshe Kotler Beer Yaakov Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01689740     History of Changes
Other Study ID Numbers: MP-9
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
Posttraumatic stress disorder
PTSD
Israel
psychotherapy

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents