Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Multidisciplinary Association for Psychedelic Studies
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT01793610
First received: February 13, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

This small ("pilot") study is designed to provide information on whether psychotherapy combined with the drug MDMA is safe and helpful for people with posttraumatic stress disorder (PTSD). The researchers plan to use the results of this study to design further studies. This study will compare two doses of MDMA: full dose or comparator-dose MDMA. There will be an initial dose possibly followed one and a half to two and a half hours later by a second dose half the size of the first dose. The study will measure symptoms of PTSD, depression, general psychological well-being and sleep after a low dose versus a full dose of MDMA. Subjects experiencing pain or tinnitus (ringing in the ears) at the start of the study will report on levels of pain or tinnitus during the study. The study will also examine whether following the standardized treatment is related to changes in PTSD symptoms. Subjects will be prepared for MDMA-assisted psychotherapy prior to the first session, and he or she will work with the same pair of therapists after having two MDMA-assisted psychotherapy sessions, with the second session occurring three to five weeks after the first session. Symptoms of PTSD, depression, general psychological well-being, feeling that you or the world are unreal (dissociation), potential positive effects of traumatic events and sleep quality will be assessed one month after the second MDMA-assisted session. Cognitive function will be measured one month after the second MDMA-assisted session. Participants who received comparator-dose MDMA can enroll in Stage 2, wherein they will have three MDMA-assisted psychotherapy sessions. People who received full-dose MDMA will have a third MDMA-assisted session. Cognitive function will be measured again after two months last Stage 1 or Stage 2 MDMA-assisted session.Subject PTSD symptoms, depression psychological symptoms, other symptoms and sleep two months after their final MDMA-assisted session and at least 12 months after they began the study.


Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: Comparator-dose MDMA
Drug: Full-dose MDMA
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: A Randomized, Double-Blind, Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscale scores. CAPS administered at primary endpoint 1 month after 2nd experimental session


Secondary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales

  • Average peak systolic blood pressure [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Peak blood pressure value will be collected every half-hour, and peak systolic blood pressure recorded for each blinded experimental session. Peak scores will be averaged

  • Average peak diastolic blood pressure [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Blood pressure measured every half-hour, and peak selected from values during each blinded experimental session, and peak values averaged

  • Average peak heart rate [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Heart rate (as pulse) measured every half-hour, and peak selected from values during each blinded experimental session, and peak values averaged

  • Average peak body temperature [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Body temperature measured every 60 to 90 minutes, and peak selected from values during each blinded experimental session, and peak values averaged

  • Average pre-drug systolic blood pressure [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Pre-drug blood pressure value(s) will be collected every half-hour, and average pre-drug systolic blood pressure will be recorded for each blinded experimental session. Pre-drug scores per session will be averaged

  • Average pre-drug diastolic blood pressure [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Pre-drug blood pressure value(s) will be collected for each blinded experimental session. Pre-drug values for each session will be averaged.

  • Average pre-drug heart rate [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Pre-drug heart rate (as pulse) value(s) will be collected for each blinded experimental session. Pre-drug values for each session will be averaged.

  • Average pre-drug body temperature [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Pre-drug body temperature value(s) will be collected for each blinded experimental session. Pre-drug values for each session will be averaged.

  • Average final post-drug systolic blood pressure [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    The final post-drug systolic blood pressure value will be the last value recorded during each experimental session, and average post-drug systolic blood pressure will be recorded for each blinded experimental session. Final post-drug scores per session will be averaged

  • Average final post-drug diastolic blood pressure [ Time Frame: One and two weeks after enrollment ] [ Designated as safety issue: Yes ]
    The final post-drug blood pressure value(s) will be collected for each blinded experimental session. Final post-drug values for each session will be averaged.

  • Average final post-drug heart rate [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    The final post-drug heart rate (as pulse) value will be collected for each blinded experimental session. Final post-drug values for each session will be averaged.

  • Average final post-drug body temperature [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    The final post-drug body temperature value will be collected for each blinded experimental session. Final post-drug values for each session will be averaged.

  • Average peak Subjective Units of Distress (SUD) [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Psychological distress will be measured every 60 to 90 minutes via SUD, and peak SUD values selected during each blinded experimental session, and peak values averaged

  • Average pre-drug SUD [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    Pre-drug body SUD value(s) will be collected and recorded for each blinded experimental session. Pre-drug SUD values for each session will be averaged.

  • Average final post-drug SUD [ Time Frame: One and two months after enrollment ] [ Designated as safety issue: Yes ]
    The final post-drug SUD value will be collected for each blinded experimental session. Final post-drug values for each session will be averaged.

  • Clinician Administered PTSD Scale [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales. Measures administered two months after the 3rd experimental session.

  • Clinician Administered PTSD Scale [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales. CAPS administered 12 months after final experimental session

  • Clinician Administered PTSD Scale [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales. Administered one month after 2nd Stage 2 session

  • Clinician Administered PTSD Scale [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscales. Administered two months after 3rd Stage 2 experimental session.

  • Global Assessment of functioning [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-scored assessment of general psychological well-being (range 1-100)

  • Global Assessment of functioning [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-scored assessment of general psychological well-being (range 1-100). GAF scored at primary endpoint 1 mo post 2nd experimental session.

  • Global Assessment of functioning [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-scored assessment of general psychological well-being (range 1-100). GAF scored 12 months after final experimental session

  • Global Assessment of functioning [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-scored assessment of general psychological well-being (range 1-100). GAF scored 2 months after 3rd experimental session

  • Global Assessment of functioning [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-scored assessment of general psychological well-being (range 1-100). GAF scored 1 month after 2nd Stage 2 experimental session

  • Global Assessment of functioning [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Clinician-scored assessment of general psychological well-being (range 1-100). GAF scored 1 month after 3rd Stage 2 experimental session

  • Beck Depression Inventory II` [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Established self-report measure of symptoms of depression.

  • Beck Depression Inventory II` [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Established self-report measure of symptoms of depression. Administered one month after 2nd experimental session.

  • Beck Depression Inventory II` [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Established self-report measure of symptoms of depression. Administered two months after 3rd experimental session.

  • Beck Depression Inventory II` [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Established self-report measure of symptoms of depression. Administered 12 months after final experimental session

  • Beck Depression Inventory II` [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Established self-report measure of symptoms of depression. Administered 1 month after 2nd Stage 2 experimental session.

  • Beck Depression Inventory II` [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Established self-report measure of symptoms of depression. Administered 2 months after 3rd Stage 2 experimental session

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported sleep quality.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported sleep quality. Administered 1 month after 2nd experimental session

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported sleep quality. Administered 12 months after final experimental session

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported sleep quality. Administered 2 months after 3rd experimental session

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported sleep quality. Administered 1 month after 2nd stage 2 experimental session

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported sleep quality. Administered 2 months after 3rd stage 2 experimental session

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered 1 month after 2nd experimental session.

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered 12 months after final experimental session.

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered 2 months after 3rd experimental session.

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered 1 month after 2nd Stage 2 experimental session.

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 1.5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered on the third integrative session after experimental session 1

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 2.5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered on the third integrative session after experimental session 2

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 3.5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered on the third integrative session after experimental session 3

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 3.5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered on the third integrative session after stage 2 experimental session 1

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 4 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered on the third integrative session after stage 2 experimental session 2

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 4.5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered on the third integrative session after stage 2 experimental session 3

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms and diagnosis. Administered 2 months after the 3rd Stage 2 experimental session

  • States of Consciousness Questionnaire (SOCQ) [ Time Frame: One month post enrollment ] [ Designated as safety issue: No ]
    Assesses subjective effects and experiences of alterations in consciousness. Administered after experimental session 1

  • States of Consciousness Questionnaire (SOCQ) [ Time Frame: Two months post enrollment ] [ Designated as safety issue: No ]
    Assesses subjective effects and experiences of alterations in consciousness. Administered after experimental session 2

  • States of Consciousness Questionnaire (SOCQ) [ Time Frame: 3 months post enrollment ] [ Designated as safety issue: No ]
    Assesses subjective effects and experiences of alterations in consciousness. Administered after experimental session 3

  • States of Consciousness Questionnaire (SOCQ) [ Time Frame: 3.5 months post enrollment ] [ Designated as safety issue: No ]
    Assesses subjective effects and experiences of alterations in consciousness. Administered after Stage 2 experimental session 1

  • States of Consciousness Questionnaire (SOCQ) [ Time Frame: 4.5 months post enrollment ] [ Designated as safety issue: No ]
    Assesses subjective effects and experiences of alterations in consciousness. Administered after Stage 2 experimental session 2

  • States of Consciousness Questionnaire (SOCQ) [ Time Frame: 4.5 months post enrollment ] [ Designated as safety issue: No ]
    Assesses subjective effects and experiences of alterations in consciousness. Administered after Stage 2 experimental session 3

  • Columbia Suicide Severity Rating Scale [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses

  • Columbia Suicide Severity Rating Scale [ Time Frame: Up to 0.75 month post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses. Administered during one preparatory session prior to experimental session.

  • Average Columbia Suicide Severity Rating Scale [ Time Frame: 1 to 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses. Average across CSSRS administered during two experimental sessions, three integrative sessions and two telephone contacts

  • Peak Columbia Suicide Severity Rating Scale [ Time Frame: 1 to 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses. Peak value selected from across CSSRS administered during two experimental sessions, three integrative sessions and two telephone contacts

  • Average Columbia Suicide Severity Rating Scale [ Time Frame: 3 to 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses. Averaged across Stage 2 CSSRS administered during two experimental sessions, three integrative sessions and two telephone contacts

  • Peak Columbia Suicide Severity Rating Scale [ Time Frame: 3 to 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses. Peak value selected across Stage 2 CSSRS administered during two experimental sessions, three integrative sessions and two telephone contacts

  • Peak Columbia Suicide Severity Rating Scale [ Time Frame: 15 to 18 months post-enrollment ] [ Designated as safety issue: Yes ]
    A clinician administered and scored measure of suicidal ideation and behavior, consisting of a series of questions and adaptive to subject responses. Collected 12 months after final experimental session

  • Dissociative Experiences Scale II [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported proneness to dissociative states (derealization and depersonalization).

  • Dissociative Experiences Scale II [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]

    Assesses self-reported proneness to dissociative states (derealization and depersonalization). DES-II administered at primary endpoint

    1 month after 2nd experimental session.


  • Dissociative Experiences Scale II [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported proneness to dissociative states (derealization and depersonalization). Measures administered two months after the 3rd experimental session.

  • Dissociative Experiences Scale II [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported proneness to dissociative states (derealization and depersonalization). Measures administered 12 months after the final experimental session.

  • Dissociative Experiences Scale II [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported proneness to dissociative states (derealization and depersonalization). Administered one month after 2nd Stage 2 session.

  • Dissociative Experiences Scale II [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Assesses self-reported proneness to dissociative states (derealization and depersonalization). Administered two months after third Stage 2 session.

  • Pain and tinnitus visual analog scales [ Time Frame: 0 months after enrollment ] [ Designated as safety issue: Yes ]
    Assesses self-reported degree of pain and tinnitus via marking 100 mm line.

  • Pain and tinnitus visual analog scales [ Time Frame: 5 months after enrollment ] [ Designated as safety issue: Yes ]
    Assesses self-reported degree of pain and tinnitus via marking 100 mm line. Administered 1 month after the second experimental session.

  • Repeatable Battery for the Assessment of Neuropsychological Status Total score [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered at study baseline

  • Repeatable Battery for the Assessment of Neuropsychological Status Total score [ Time Frame: 3 months post study enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered at primary endpoint

  • Repeatable Battery for the Assessment of Neuropsychological Status Total score [ Time Frame: 5 or 7 months post study enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered 2 months post Stage 1 or stage 2 experimental session.

  • Paced Auditory Serial Addition Test Correct 3 seconds [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function (Baseline)

  • Paced Auditory Serial Addition Test Correct 3 seconds centile [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function (centile score) (Baseline)

  • Paced Auditory Serial Addition Test Correct 2 seconds [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function (Baseline)

  • Paced Auditory Serial Addition Test Correct 2 seconds centile [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function centile (Baseline)

  • Paced Auditory Serial Addition Test Correct 3 seconds [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered at primary endpoint

  • Paced Auditory Serial Addition Test Correct 3 seconds centile [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function (centile score). Administered at primary endpoint

  • Paced Auditory Serial Addition Test Correct 2 seconds [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered at primary endpoint

  • Paced Auditory Serial Addition Test Correct 2 seconds centile [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function centile score. Administered at primary endpoint

  • Paced Auditory Serial Addition Test Correct 3 seconds [ Time Frame: 5 months or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered 2 months post third Stage 1 or Stage 2 experimental session.

  • Paced Auditory Serial Addition Test Correct 3 seconds centile [ Time Frame: 5 months or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function (centile score). Administered two months post third Stage 1 or Stage 2 experimental session.

  • Paced Auditory Serial Addition Test Correct 2 seconds [ Time Frame: 5 months or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Administered 2 months post third Stage 1 or Stage 2 experimental session

  • Paced Auditory Serial Addition Test Correct 2 seconds centile [ Time Frame: 5 months or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function centile score. Administered 2 months post third Stage 1 or Stage 2 experimental session

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure assessing potential benefits or reframing of traumatic event or events (Baseline)

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure assessing potential benefits or reframing of traumatic event or events. Administered at primary endpoint

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure assessing potential benefits or reframing of traumatic event or events. Administered at long-term follow up 12 months after final experimental session

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure assessing potential benefits or reframing of traumatic event or events. Administered 2 months after third experimental session

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 5 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure assessing potential benefits or reframing of traumatic event or events. Administered at secondary endpoint 1 month post 2nd Stage 2 experimental session.

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 7 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure assessing potential benefits or reframing of traumatic event or events. Administered two months after third Stage 2 experimental session.


Estimated Enrollment: 12
Study Start Date: April 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Comparator-dose MDMA
Participants receive initial doses of comparator-dose MDMA during each of two experimental sessions.
Drug: Comparator-dose MDMA
Initial comparator-dose MDMA orally at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose MDMA.
Other Name: 3,4-methylenedioxymethamphetamine
Experimental: Full-dose MDMA
Participants receive and initial dose of full-dose MDMA during each of two experimental sessions.
Drug: Full-dose MDMA
An initial dose of full-dose MDMA orally given at the start of each of two psychotherapy sessions and possibly followed a dose half the size of the initial dose of MDMA 1.5 to 2.5 hours later.
Other Name: 3,4-methylenedioxymethamphetamine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with chronic PTSD for at least six months
  • Have a CAPS score of 50 or higher, indicating moderate to severe PTSD symptoms
  • At least one unsuccessful treatment for PTSD either with psychotherapy (talk therapy) or with drugs (like SSRIs) or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy
  • Are at least 18 years old
  • If in ongoing psychotherapy at the time of recruitment, must sign a release permitting the investigators to communicate directly with their therapist and may not change therapists, increase frequency of therapy or commence any new type of therapy until after the evaluation two months after their final experimental session
  • Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control or stimulants for ADHD if discontinued 5 half lives before an experimental session and not restarted until ten days after an experimental session.
  • Agree that for one week before each experimental MDMA session, subject will refrain from taking all listed below unless given prior approval from researchers: herbal supplements, non-prescription medications (with the exception of non-steroidal anti-inflammatory drugs and acetaminophen) or any prescription medication, except for birth control pills, thyroid hormone or other investigator-approved medications
  • Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA session.
  • Are willing to remain overnight at the study site
  • Agree to have another person transport them from the site home or to where they are staying after each MDMA session
  • Are willing to be contacted via telephone on a daily basis for a week after each experimental session
  • 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 subject becoming suicidal
  • Agree to let the investigators know within 48 hours of any planned medical interventions;
  • Agree not to participant in any other interventional clinical trials during the course of the study
  • Are proficient in reading and speaking English
  • Agree to have all psychotherapy sessions recorded to audio/video.

Exclusion Criteria:

  • Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
  • Have past or current psychotic disorder, bipolar affective disorder type 1, borderline personality disorder or dissociative identity disorder, or an eating disorder with active purging
  • Have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration
  • Have hypertension
  • Have evidence or history of liver disease
  • Have Diabetes Type I or II
  • Have history of hyponatremia or hyperthermia
  • Weigh less than 48 kg
  • Would present a serious suicide risk,or are likely to require hospitalization during the course of the study
  • Have used "Ecstasy" (material represented as containing MDMA) more than five times in the last ten years or at least once within 6 months of the MDMA session
  • Require ongoing concomitant therapy with a psychiatric drug
  • Meet criteria for substance abuse or dependence for any substance in the past 60 days save caffeine or nicotine
  • Have glaucoma, significant atherosclerosis or hyperthyroidism
  • Have any current problem, which in the opinion of the investigator or medical monitor, might interfere with participation in the study
  • Are 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: NCT01793610

Contacts
Contact: Peggy Ivers Iverspm@gmail.com

Locations
United States, Colorado
Offices of Marcela d'Otalora Recruiting
Boulder, Colorado, United States, 80304
Principal Investigator: Marcela d'Otalora, MA. LPC         
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Marcela d'Otalora, MA, LPC Private practice
Study Chair: Rick Doblin, PhD Multidisclipinary Association for Psychedelic Studies
  More Information

No publications provided

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01793610     History of Changes
Other Study ID Numbers: MP-12
Study First Received: February 13, 2013
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
Posttraumatic stress disorder
sleep
Depression
Safety

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
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 September 18, 2014