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Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Multidisciplinary Association for Psychedelic Studies
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT01958593
First received: October 7, 2013
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

This small ("pilot") study is designed to provide information on whether the combination of psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress disorder (PTSD). The researchers will use the results of this study to design more studies of this treatment. The study compares a comparator and a full dose. For each session, there will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the size of the initial dose. The study will measure symptoms of PTSD, depression, general psychological well-being, sleep quality, feelings that the self or world is unreal (dissociation), potentially positive effects of surviving traumatic events and cognitive function (thinking, memory and attention). People experiencing pain or tinnitus (ringing in the ears) will record their symptoms throughout the study. Seven people will be randomly (by chance) assigned to receive full-dose MDMA and five will be randomly assigned to receive a comparator. There will be three preparatory psychotherapy sessions before the first experimental session, and subjects will have supportive or "integrative" sessions after each MDMA-assisted psychotherapy session. Subjects will meet with a male and female psychotherapist for all experimental sessions and for sessions before and after each experimental session. Subjects who received comparator can enroll in Stage 2, where they will have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know they are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have a third experimental session.. Symptoms of PTSD and other symptoms will be measured again at least 12 months after each subject has started the study.


Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: Comparator
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: Prevention
Official Title: A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) - Canada

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Clinician-Administered PTSD Scale Score [ Time Frame: 0 to 3 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 subscale scores. Change from CAPS administered at Baseline to primary endpoint 1 month after 2nd experimental session


Secondary Outcome Measures:
  • Change in CAPS score [ Time Frame: 5 or 7 months post enrollment to 15 - 18 months post-enrollment ] [ Designated as safety issue: No ]
    Change from CAPS administered at Stage end (2 months post Stage 1/Stage 2 third experimental session) to CAPS at 12-month follow up (LTFU)

  • Change in CAPS score [ Time Frame: 3 to 5 months or 5-7 months post-enrollment ] [ Designated as safety issue: No ]
    Either Stage 1 - change in CAPS from primary endpoint to 2 months post 3rd experimental session OR Stage 2 change in CAPS from secondary endpoint (1 month post second stage 2 experimental session) to stage 2 end (2 months post 3rd stage 2 experimental session).

  • Change in Beck Depression Inventory Score [ Time Frame: 0 to 3 months post enrollment ] [ Designated as safety issue: No ]
    Change from BDI score administered at Baseline to BDI at primary endpoint one month post second experimental session

  • Change in Beck Depression Inventory Score [ Time Frame: 5 or 7 months post-enrollment to 15 - 18 months post enrollment ] [ Designated as safety issue: No ]
    Change in BDI score from Stage End (2 months post Stage 1/Stage 2 third experimental session) to 12-month follow up 15 to 18 months post enrollment (Long Term Follow Up)

  • Change in Beck Depression Inventory Score [ Time Frame: 3 to 5 months or 5-7 months post enrollment ] [ Designated as safety issue: No ]
    Either Stage 1 - change in BDI score from primary endpoint to 2 months post 3rd experimental session OR Stage 2 change in BDI from secondary endpoint (1 month post second stage 2 experimental session) to stage 2 end (2 months post 3rd stage 2 experimental session).

  • Change in Global Assessment of Functioning [ Time Frame: 0 to 3 months post enrollment ] [ Designated as safety issue: No ]
    Change in GAF score at Baseline to GAF at primary endpoint 1 month post second experimental session

  • Change in Global Assessment of Functioning [ Time Frame: 5 or 7 months post-enrollment to 15-18 months post enrollment ] [ Designated as safety issue: No ]
    Change in GAF score at Stage end (2 months post Stage 1/Stage 2 third experimental session) to 12-month follow up (LTFU)

  • Change in Global Assessment of Functioning [ Time Frame: 3 to 5 months post enrollment or 5-7 months post enrollment ] [ Designated as safety issue: No ]
    Either Stage 1: change in GAF score from primary endpoint to 2 mo post 3rd experimental session OR Stage 2: change in GAF score from secondary endpoint (1 mo post second stage 2 exp session) to stage 2 end (2 mo post 3rd stage 2 experimental session).

  • Change in Post traumatic Diagnostic Scale score [ Time Frame: 0 to 3 months post enrollment ] [ Designated as safety issue: No ]
    Change PDS severity score at Baseline to primary endpoint 1 month after second experimental session.

  • Change in Post traumatic Diagnostic Scale score [ Time Frame: 5 or 7 months post-enrollment to 15-18 months post enrollment ] [ Designated as safety issue: No ]
    Change in PDS severity score at Stage end (2 mo post Stage1/Stage 2 third experimental session) to PDS severity score at 12-month follow up (LTFU)

  • Change in Post traumatic Diagnostic Scale score [ Time Frame: 3 to 5 months post-enrollment or 5-7 months post-enrollment ] [ Designated as safety issue: No ]
    Either Stage 1: Change in PDS severity score at primary endpoint (1 month post Stage 1 second experimental session) to PDS at end of Stage 1 (2 months post stage 2 third experimental session) OR Stage 2: Change in PDS severity score at secondary endpoint (1 month post Stage 2 second experimental session) to end of Stage 2 (2 months post Stage 2 third experimental session)

  • Post traumatic Diagnostic Scale score [ Time Frame: 1.75 months post enrollment ] [ Designated as safety issue: No ]
    PDS scores at third integrative session (Stage 1)

  • Post traumatic Diagnostic Scale score [ Time Frame: 2.75 months post enrollment ] [ Designated as safety issue: No ]
    PDS scores at sixth integrative session (Stage 1)

  • Post traumatic Diagnostic Scale score [ Time Frame: 3.75 months post enrollment ] [ Designated as safety issue: No ]
    PDS scores at ninth integrative session (Stage 1) - full dose subjects only

  • Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 0 to 3 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of sleep quality. PSQI administered at Baseline to primary endpoint (1 month post second experimental session).

  • Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 or 7 months post-enrollment to to 15-18 months post enrollment ] [ Designated as safety issue: No ]
    Change in PSQI administered end of Stage 1 or 2 (2 months post Stage 1/Stage 2 third experimental session) to PSQI at 12-month follow up (LTFU)

  • Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 to 5 months post-enrollment or 5-7 months poist-enrollment ] [ Designated as safety issue: No ]
    Either Stage 1: Change in PSQI at primary endpoint (1 month post Stage 1 second experimental session) to PSQI at end of Stage 1 (2 mo post third expt session) OR Stage 2: PSQI at secondary endpoint (1 m post Stage 2 second expt session) to end of Stage 2 (2 mo post Stage 2 third expt session)

  • Change in Post traumatic Growth Inventory scores [ Time Frame: 0 to 3 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measurement of positive changes after traumatic event(s). Change in PTGI scores administered at Baseline and PTGI scores at primary endpoint (1 month post second experimental session)

  • Change in Post traumatic Growth Inventory scores [ Time Frame: 5 or 7 months post-enrollment to 15-18 months post-enrollment ] [ Designated as safety issue: No ]
    Change in PTGI scores administered end of Stage 1 or 2 (2 month post Stage 1/Stage 2 third experimental session) to PTGI at 12-month follow up (LTFU)

  • Change in Post traumatic Growth Inventory scores [ Time Frame: 3 to 5 months post-enrollment or 5-7 months post-enrollment ] [ Designated as safety issue: No ]
    Either Stage 1: Change in PTGI scores administered at primary endpoint (1 month post Stage 1 second experimental session) to PTGI at end of Stage 1 (2 months post Stage 1 third experimental session) or Stage 2: Change in PTGI scores from secondary endpoint (1 month post Stage 2 second experimental session) to end of Stage 2 (2 months post Stage 2 third experimental session)

  • Changes in Dissociation Experiences Scale II Scores [ Time Frame: 0 to 3 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report of feeling that the self or surroundings are unreal (dissociation). Change in DES-2 scores administered at Baseline and at primary endpoint (1 month post second experimental session)

  • Changes in Dissociation Experiences Scale II Scores [ Time Frame: 5 or 7 mo post-enrollment to 15-18 mo post-enrollment ] [ Designated as safety issue: No ]
    Change in DES-2 scores administered administered end of Stage 1 or 2 (2 mo post Stage 1/Stage 2 third experimental session) to DES-2 scores at 12-month follow up (LTFU)

  • Changes in Dissociation Experiences Scale II Scores [ Time Frame: 3 to 5 mo post-enrollment or 5-7 mo post enrollment ] [ Designated as safety issue: No ]
    Either Stage 1: Change in DES-2 scores administered at primary endpoint (1 month post Stage 1 second experimental session) to end of Stage 1 (2 mo post third stage 1 expt session) or Stage 2: Change in DES-2 at secondary endpoint (1 mo post stage 2 second expt session) to end of Stage 2 (2 mo post Stage 2 third expt session)

  • Change in VAS scale somatic symptoms of pain/tinnitus [ Time Frame: 0 to 3 mo post-enrollment ] [ Designated as safety issue: No ]
    Self-rated pain or tinnitus symptoms on visual analog scale, completed only by participant with baseline symptoms. Change in VAS pain/tinnitus from Baseline to primary endpoint (1 mo post second experimental session).

  • Change in VAS scale somatic symptoms of pain/tinnitus [ Time Frame: 5 or 7 mo post enrollment to 15-18 mo post-enrollment ] [ Designated as safety issue: No ]
    Change in VAS pain/tinnitus completed at the end of Stage 1 or 2 (2 mo post Stage 1/Stage 2 third experimental session) to VAS pain/tinnitus symptoms at 12-month follow up (LTFU). Completed only by those reporting baseline symptoms.

  • Change in VAS scale somatic symptoms of pain/tinnitus [ Time Frame: 3 or 5 mo post-enrollment ] [ Designated as safety issue: No ]
    Either Stage 1: Change in VAS pain/tinnitus completed at primary endpoint (1 month post Stage 1 second experimental session) to VAS pain/tinnitus at end of stage 1 (2 mo post Stage 1 third expt session) or Stage 2: VAS pain/tinnitus ratings at secondary endpoint (1 mo post Stage 2 second expt session) to end of Stage 2 (2 mo post Stage 2 third expt session)

  • Average VAS scale somatic symptoms of pain/tinnitus - baseline to primary endpoint [ Time Frame: 0 to 3 mo post-enrollment ] [ Designated as safety issue: No ]
    Mean VAS pain/tinnitus ratings (mean Baseline to primary endpoint 1 month post second experimental session. VAS completed only by those with baseline symptoms.

  • Change in Neuroticism Extroversion Openness Personality Inventory Revised (NEO-PI-R) [ Time Frame: 0 to 3 mo post-enrollment ] [ Designated as safety issue: No ]
    Self-report personality inventory including neuroticism, extroversion, openness, conscientiousness and agreeableness scores. Change in NEO-PI-R scores from Baseline to primary endpoint 1 mo post second experimental session

  • Change in Neuroticism Extroversion Openness Personality Inventory Revised (NEO-PI-R) [ Time Frame: 3 or 7 mo post-enrollment to 15-18 mo post enrollment ] [ Designated as safety issue: No ]
    Change in NEO-PI-R scores from final stage 1/stage 2 measure (either 1 mo post second experimental session or 2 mo post Stage 2 third experimental session to 12 mo follow up (LTFU)

  • Change in Neuroticism Extroversion Openness Personality Inventory Revised (NEO-PI-R) [ Time Frame: 3 to 7 mo post-enrollment ] [ Designated as safety issue: No ]
    Change in NEO-PI-R scores from primary endpoint (1 mo post Stage 1 second experimental session) to end of Stage 2 (2 mo post Stage 2 third 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. Measured at Baseline

  • Repeatable Battery for the Assessment of Neuropsychological Status Total score [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Measured at primary endpoint (1 mo post second experimental session)

  • Repeatable Battery for the Assessment of Neuropsychological Status Total score [ Time Frame: 5 or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    Assesses cognitive function. Measured at Stage end (2 mo post Stage1/Stage 2 third experimental session)

  • Paced Auditory Serial Addition Test 3 seconds Correct [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Measures cognitive function. Administered at Baseline.

  • Paced Auditory Serial Addition Test 3 seconds Correct Centile [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    Measures cognitive function; Centile score. Administered at Baseline.

  • Paced Auditory Serial Addition Test 2 seconds Correct [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    PASAT score administered at Baseline.

  • Paced Auditory Serial Addition Test 2 seconds Correct Centile score [ Time Frame: 0 months post-enrollment ] [ Designated as safety issue: Yes ]
    PASAT centile score administered at Baseline.

  • Paced Auditory Serial Addition Test 3 seconds Correct [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Measures cognitive function. Administered at primary endpoint (1 mo post second experimental session)

  • Paced Auditory Serial Addition Test 3 seconds Correct Centile [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Measures cognitive function; Centile score. Administered at primary endpoint (1 mo post second experimental session)

  • Paced Auditory Serial Addition Test 2 seconds Correct [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    PASAT score administered at Primary Endpoint (1 mo post second experimental session)

  • Paced Auditory Serial Addition Test 2 seconds Correct Centile score [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    PASAT centile score administered at Primary Endpoint (1 mo post second experimental session)

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

  • Paced Auditory Serial Addition Test 3 seconds Correct Centile [ Time Frame: 5 or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    Measures cognitive function; Centile score. Administered at stage end (2 mo post Stage 1/Stage 2 third experimental session

  • Paced Auditory Serial Addition Test 2 seconds Correct [ Time Frame: 5 or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    PASAT score administered at stage end (2 mo post Stage 1/Stage 2 third experimental session

  • Paced Auditory Serial Addition Test 2 seconds Correct Centile score [ Time Frame: 5 or 7 months post-enrollment ] [ Designated as safety issue: Yes ]
    PASAT centile score administered at stage end (2 mo post Stage 1/Stage 2 third experimental session

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 0 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 response

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: up to 0.8 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 response

  • Average Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 1 to 3 month post-enrollment ] [ Designated as safety issue: Yes ]
    Average CSSRS score up to primary endpoint and including twice on two experimental sessions, two sets of three integrative sessions and two sets of two contact days

  • Peak Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 1 to 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Peak CSSRS score selected from CSSRS administered up to primary endpoint and including twice on two experimental sessions, two sets of three integrative sessions and two sets of two contact days

  • Average Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 3 to 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average CSSRS score up to end of Stage 2 and including twice on three experimental sessions, three sets of three integrative sessions and of two contact days

  • Peak Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 3 to 6 mo post-enrollment ] [ Designated as safety issue: Yes ]
    Peak CSSRS score selected from CSSRS administered throughout Stage 2, including twice during 3 experimental sessions and 3 sets of three integrative sessions and two telephone days

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 15 to 18 months post-enrollment ] [ Designated as safety issue: Yes ]
    CSSRS score selected at 12-month follow up

  • Stage 1 average pre-drug systolic blood pressure [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration SBP values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average pre-drug systolic blood pressure [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration SBP values across all three stage 2 experimental sessions

  • Stage 1 average peak systolic blood pressure [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest (peak) SBP values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average peak systolic blood pressure [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest value (peak)SBP values across all three stage 2 experimental sessions

  • Stage 1 average session end systolic blood pressure [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average end-of-session SBP values assessed across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average session-end systolic blood pressure [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average session-end SBP values across all three stage 2 experimental sessions

  • Stage 1 average pre-drug diastolic blood pressure [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration DBP values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average pre-drug diastolic blood pressure [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration DBP values across all three stage 2 experimental sessions

  • Stage 1 average peak diastolic blood pressure [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest (peak) DBP values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average peak diastolic blood pressure [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest value (peak)DBP values across all three stage 2 experimental sessions

  • Stage 1 average session end diastolic blood pressure [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average end-of-session DBP values assessed across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average session-end diastolic blood pressure [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average session-end DBP values across all three stage 2 experimental sessions

  • Stage 1 average pre-drug heart rate [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration HR values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average pre-drug heart rate [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration HR values across all three stage 2 experimental sessions

  • Stage 1 average peak heart rate [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest (peak) SBP values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 1 average session end heart rate [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average end-of-session HR values assessed across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average session-end heart rate [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average session-end HR values across all three stage 2 experimental sessions

  • Stage 2 average peak heart rate [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest value (peak)HR values across all three stage 2 experimental sessions

  • Stage 1 average pre-drug body temperature [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration BT values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average pre-drug body temperature [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration BT values across all three stage 2 experimental sessions

  • Stage 1 average peak body temperature [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest (peak) SBP values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average body temperature [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest value (peak)BT values across all three stage 2 experimental sessions

  • Stage 1 average session end body temperature [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average end-of-session SBP values assessed across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average session-end body temperature [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average session-end BT values across all three stage 2 experimental sessions

  • Stage 1 average pre-drug Subjective Unit of Distress [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration SUD values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average pre-drug Subjective Unit of Distress [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average pre-drug administration SUD values across all three stage 2 experimental sessions

  • Stage 1 average peak Subjective Unit of Distress [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest (peak) SUD values across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average peak Subjective Unit of Distress [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average highest value (peak)SUD values across all three stage 2 experimental sessions

  • Stage 1 average session end Subjective Unit of Distress [ Time Frame: 1, 2 and 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average end-of-session SUD values assessed across all stage 1 experimental sessions, including both blinded sessions for all subjects and third session for full dose subjects

  • Stage 2 average session-end Subjective Unit of Distress [ Time Frame: 4, 5 and 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    Average session-end SUD values across all three stage 2 experimental sessions


Other Outcome Measures:
  • Mean States of Consciousness Questionnaire total score [ Time Frame: 1 to 3 months post-enrollment ] [ Designated as safety issue: No ]
    Self-report measure of alterations in consciousness. Contains total score and seven sub-scales. Completed after each Stage 1 session (first, second and third)

  • Mean States of Consciousness Questionnaire total score [ Time Frame: 3.5 to 6 months post-enrollment ] [ Designated as safety issue: No ]
    Average (mean) SOCQ score completed after each Stage 2 session (first, second and third)


Estimated Enrollment: 12
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Comparator
Participants will receive comparator during each of two experimental sessions.
Drug: Comparator
Comparator administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment
Other Name: Comparator
Experimental: Full-dose MDMA
Participants will receive full-dose MDMA during each of two experimental sessions.
Drug: Full-dose MDMA
Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.
Other Names:
  • 3,4-methyelenedioxymethamphetamine
  • MDMA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with PTSD for at least 6 months
  • Have a global CAPS score equal to or greater than 60
  • At least one unsuccessful treatment either with psychotherapy (talk therapy) or pharmacotherapy (drug therapy)or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy
  • 21 years old or older
  • If currently in psychotherapy, must sign a release permitting the investigators to communicate directly with their therapist
  • 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
  • Stop taking any psychiatric medications during the study period, with the exception of gabapentin for pain control or stimulants for ADHD (those must be discontinued 5 half lives before an experimental session and not restarted until ten days afterwards).
  • Agree to follow all study-related instructions and restrictions provided by the researchers
  • Are willing to remain overnight at the site after each experimental session
  • Agree to have another person transport them from the site home or to where they are staying after each experimental session
  • Willing to be contacted daily for a week by one of the researchers
  • willing to provide a contact reachable by the researchers in the event of a subject becoming suicidal
  • Have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control
  • Agree to have all sessions recorded to audio and video
  • Literate and proficient in reading and speaking English

Exclusion Criteria:

  • Pregnant or nursing, or women of child bearing potential who are not practicing an effective means of birth control
  • History of or current primary psychotic disorder or bipolar affective disorder type 1 or borderline personality disorder
  • Have dissociative identity disorder or an eating disorder with active purging
  • Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, cardiac, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the Principal Clinical Investigator to significantly increase the risk of MDMA administration
  • Have hypertension using the standard criteria of the American Heart Association, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia
  • Weigh less than 48 kg
  • Have used "Ecstasy" (illicit drug preparations purported to contain MDMA) more than five times in the last 10 years or at least once within six months of enrollment
  • Would present a serious suicide risk, or who are likely to require hospitalization during the course of the study
  • Require ongoing concomitant therapy with a psychiatric drug, including but not limited to SSRIs, SNRIs, or MAOIs
  • Active substance abuse or dependence for any substance other than caffeine or nicotine in the past 6 months
  • Are not able to give adequate informed consent
  • Have any current problem, which in the opinion of the Principal Clinical Investigator or Medical Monitor, might interfere with participation in the study
  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: NCT01958593

Contacts
Contact: Deborah Kraus 604-336-4822 info.mp4canada@gmail.com

Locations
Canada, British Columbia
Offices of Dr. Ingrid Pacey MBBS FRCP[C] Recruiting
Vancouver, British Columbia, Canada, V6R 1N6
Contact: Deborah Kraus    604-336-4822    mp4@mdmasites.org   
Sub-Investigator: Donna Dryer, MD, FRCP[C]         
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Ingrid Pacey, MBBS FRCP[C] University of Victoria
  More Information

No publications provided

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01958593     History of Changes
Other Study ID Numbers: MP-4
Study First Received: October 7, 2013
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
N-Methyl-3,4-methylenedioxyamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Agents
Hallucinogens
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014