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

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ClinicalTrials.gov Identifier: NCT01793610
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : October 14, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE February 13, 2013
First Posted Date  ICMJE February 15, 2013
Results First Submitted Date  ICMJE June 29, 2020
Results First Posted Date  ICMJE October 14, 2020
Last Update Posted Date November 3, 2020
Study Start Date  ICMJE October 2012
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score at Baseline (ITT) [ Time Frame: Baseline Enrollment ]
    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. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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.
  • Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score at One Month Post 2nd Experimental Session (ITT) [ Time Frame: One month after 2nd experimental session (approximately 3 months post enrollment) ]
    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. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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.
  • Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session (ITT) [ Time Frame: Baseline Enrollment to 1-Month Post 2nd 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. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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: February 14, 2013)
Clinician Administered PTSD Scale [ Time Frame: 3 months after enrollment ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Beck Depression Inventory II (BDI-II) at Baseline (ITT) [ Time Frame: Baseline Enrollment ]
    Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
  • Beck Depression Inventory II (BDI-II) at One Month Post 2nd Experimental Session (ITT) [ Time Frame: One month after 2nd experimental session (approximately 3 months post enrollment) ]
    Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
  • Change in Beck Depression Inventory II (BDI-II) From Baseline to One Month Post 2nd Experimental Session (ITT) [ Time Frame: Baseline Enrollment to 1-Month Post 2nd Experimental Session ]
    Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
  • Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to One Month Post 2nd Experimental Session (ITT) [ Time Frame: Baseline Enrollment to 1-Month Post 2nd Experimental Session ]
    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2013)
  • Clinician Administered PTSD Scale [ Time Frame: 0 months post-enrollment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Clinician-scored assessment of general psychological well-being (range 1-100)
  • Global Assessment of functioning [ Time Frame: 3 months post-enrollment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Established self-report measure of symptoms of depression.
  • Beck Depression Inventory II' [ Time Frame: 3 months post-enrollment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Assesses self-reported sleep quality.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months post-enrollment ]
    Assesses self-reported sleep quality. Administered 1 month after 2nd experimental session
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 15-18 months post-enrollment ]
    Assesses self-reported sleep quality. Administered 12 months after final experimental session
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 months post-enrollment ]
    Assesses self-reported sleep quality. Administered 2 months after 3rd experimental session
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 months post-enrollment ]
    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 ]
    Assesses self-reported sleep quality. Administered 2 months after 3rd stage 2 experimental session
  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 0 months post-enrollment ]
    Self-report measure of PTSD symptoms and diagnosis
  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 3 months post-enrollment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Official Title  ICMJE 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)
Brief Summary

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life. This Phase 2 pilot study examined the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant posttraumatic stress disorder (PTSD). This study is part of a global series of Phase 2 pilot clinical trials. This randomized, double-blind, dose response study assessed two active doses of MDMA, 100 mg and 125 mg, to a comparator dose of MDMA (40 mg) during psychotherapy sessions. The initial dose was followed 1.5 to 2.5 hours later by an optional supplemental dose of MDMA that was half the size of the first dose. MDMA was administered in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart. Subjects were prepared for MDMA-assisted psychotherapy prior to the first session in three preparatory sessions, and worked with the same pair of therapists throughout the study. After each MDMA-assisted psychotherapy session, subjects had three integrative sessions with their therapist team to process and understand their experience.

This study assessed the change in symptoms of PTSD, as measured by the Clinical Administered PTSD Scale (CAPS) [Blake et al., 1995], as well as symptoms of depression, as measured by the Beck Depression Inventory II (BDI-II) [Beck, A.T. and R.A, 1984; Beck, A.T., et al., 1996] from baseline enrollment to one month after the second MDMA-assisted psychotherapy session (primary endpoint).

Participants who received the comparator dose of MDMA (40 mg) were given the option to enroll in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions with an active dose of MDMA. People who received either of the active doses of MDMA in Stage 1 had a third MDMA-assisted psychotherapy session with another active dose of MDMA.

Detailed Description

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a person experiences a traumatic event, such as sexual assault, war, or any other life-threatening event. PTSD is a worldwide health problem that severely reduces a person's quality of life and is associated with high rates of psychiatric and medical comorbidity, disability, suffering, and suicide. At least a third of PTSD patients fail to respond to established PTSD psychotherapies. A wider array of effective treatments for PTSD are needed.

3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a potential treatment option for PTSD. MDMA is a monoamine releaser that affects serotonin, norepinephrine, and dopamine. MDMA is capable of inducing unique psychopharmacological effects such as decreased feelings of fear, increased feelings of wellbeing, increased sociability and extroversion, increased interpersonal trust, and an alert state of consciousness. In the U.S., MDMA was used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists before it was placed in Schedule I in 1985 as a result of non-medical use.

This Phase 2 pilot study is a randomized, double-blind, dose response study to examine the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant PTSD of at least six months duration. This study is part of a global series of Phase 2 pilot clinical trials. This study assessed two active doses of MDMA, active dose 1 (100 mg) and active dose 2 (125 mg), to a comparator dose of MDMA (40 mg) during psychotherapy sessions. The initial dose of MDMA was followed 1.5 to 2.5 hours later by an optional supplemental dose of MDMA that was half the size of the first dose. MDMA was administered orally in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart.

Subjects were prepared for MDMA-assisted psychotherapy in three preparatory sessions prior to the first experimental session, and worked with the same pair of therapists throughout the study. After each experimental session, three integrative sessions were scheduled with the subject, including one integrative session the morning after the experimental session. During integrative sessions, subjects processed and connected their thoughts and feelings about the experience with their therapist team.

Subjects who received the comparator dose (40 mg) were given the option to enroll in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions. 100 mg of MDMA was administered in the first session and therapists determined whether to increase to 125 mg of MDMA for the second and third experimental sessions. People who received 125 mg of MDMA during the first two experimental sessions received the same dose during an open-label third experimental session. People who received 100 mg of MDMA during the first two sessions were able to choose, in consultation with their therapist, to either continue to receive 100 mg in a third session or to increase their dose to 125 mg.

A blinded independent rater (IR) assessed the severity of PTSD symptoms at baseline, one month after the second experimental session (the primary endpoint), two months after the third open-label experimental session, and at equivalent points in Stage 2.

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: Comparative-dose (40mg) MDMA
    An initial comparator-dose of 40 mg MDMA orally given 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 (20 mg MDMA).
    Other Name: 3,4-methylenedioxymethamphetamine
  • Drug: Active Dose 2 (100 mg) MDMA
    An initial dose of full-dose 100 mg MDMA orally given 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 (50 mg MDMA).
    Other Name: 3,4-methylenedioxymethamphetamine
  • Drug: Active Dose 1 (125 mg) MDMA
    An initial dose of full-dose 125 mg MDMA orally given 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 (62.5 mg MDMA).
    Other Name: 3,4-methylenedioxymethamphetamine
  • Behavioral: Psychotherapy
    Psychotherapy conducted throughout experimental sessions.
    Other Name: Manualized MDMA-assisted psychotherapy
Study Arms  ICMJE
  • Active Comparator: Comparator-dose (40 mg) MDMA and Psychotherapy
    Participants receive an initial dose of comparator-dose MDMA (40 mg) during each of the two experimental sessions.
    Interventions:
    • Drug: Comparative-dose (40mg) MDMA
    • Behavioral: Psychotherapy
  • Experimental: Active Dose 2 (100 mg) MDMA and Psychotherapy
    Participants receive an initial dose of Active Dose 2 MDMA (100 mg) during each of the two experimental sessions.
    Interventions:
    • Drug: Active Dose 2 (100 mg) MDMA
    • Behavioral: Psychotherapy
  • Experimental: Active Dose 1 (125 mg) MDMA and Psychotherapy
    Participants receive an initial dose of Active Dose 1 MDMA (125 mg) during each of two experimental sessions.
    Interventions:
    • Drug: Active Dose 1 (125 mg) MDMA
    • Behavioral: Psychotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2013)
12
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with chronic PTSD for six months or longer.
  • Have a CAPS score showing moderate to severe PTSD symptoms.
  • 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.
  • Are at least 18 years old.
  • Must be generally healthy.
  • Are willing to refrain from taking any psychiatric medications during the study period.
  • Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA session.
  • Willing to remain overnight at the study site.
  • Are willing to be driven home after experimental sessions either by a driver they arrange, a taxi, or study personnel.
  • Are willing to be contacted via telephone by study personnel.
  • If of child-bearing age, must have a negative pregnancy and agree to use an effective form of birth control.
  • Must provide a personal contact who is willing to be reached in case of emergency.
  • Agree to let the investigators know within 48 hours of any planned medical interventions.
  • Are proficient in reading and speaking English.
  • Agree to have all psychotherapy sessions recorded.
  • Agree not to participate in any other interventional clinical trials during the course of the study.

Exclusion Criteria:

  • Are pregnant or nursing, or if of child-bearing age and do not use 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01793610
Other Study ID Numbers  ICMJE MP-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcela d'Otalora, MA, LPC Private Practice
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date October 2020

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