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Additional MDMA-assisted Psychotherapy for People Who Relapsed After MDMA-assisted Psychotherapy Trial

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT01458327
First received: October 12, 2011
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

This study will consist of a single session of MDMA-assisted psychotherapy with a full dose of MDMA for people who took part in a study of MDMA-assisted psychotherapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.


Condition Intervention Phase
Posttraumatic Stress Disorder
 Drug: 3,4-methylenedioxymethamphetmine (MDMA)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Psychotherapy Session in People Who Relapsed After Participating in a Phase 2 Clinical Trial of MDMA-Assisted Psychotherapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: Two months post-session ] [ Designated as safety issue: No ]
    Measures PTSD symptoms

  • Clinician Administered PTSD Scale [ Time Frame: 12 months post session ] [ Designated as safety issue: No ]
    Measures PTSD symptoms

  • Clinician Administered PTSD Scale [ Time Frame: Prior to session ] [ Designated as safety issue: No ]
    Measures PTSD symptoms


Secondary Outcome Measures:
  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Prior to study session ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms

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

  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 12 months post session ] [ Designated as safety issue: No ]
    Self-report measure of PTSD symptoms

  • Global Assessment of Functioning [ Time Frame: Prior to session ] [ Designated as safety issue: No ]
    Observer-rated assessment of general psychological function

  • Global Assessment of Functioning [ Time Frame: Two months post session ] [ Designated as safety issue: No ]
    Observer-rated assessment of general psychological function

  • Global Assessment of Functioning [ Time Frame: 12 months post sesssion ] [ Designated as safety issue: No ]
    Observer-rated assessment of general psychological function

  • Beck Depression Inventory II (BDI-II) [ Time Frame: Prior to session ] [ Designated as safety issue: No ]
    Self-report measure of symptoms of depression

  • Beck Depression Inventory II (BDI-II) [ Time Frame: Two months post session ] [ Designated as safety issue: No ]
    Self-report measure of symptoms of depression

  • Beck Depression Inventory II (BDI-II) [ Time Frame: 12 months post session ] [ Designated as safety issue: No ]
    Self-report measure of symptoms of depression

  • Peak systolic blood pressure [ Time Frame: Peak from measurements taken every 15 to 30 minutes up through 8 h during experimental session ] [ Designated as safety issue: Yes ]
    Measures systolic blood pressure

  • Peak Pulse [ Time Frame: Peak pulse from measures taken every15 to 30 minutes for up to 8 hours during experimental session ] [ Designated as safety issue: Yes ]
    Measures pulse

  • Peak body temperature (BT) [ Time Frame: Peak from measurements made every 60 to 90 minutes for up to 8 hours during each experimental session ] [ Designated as safety issue: Yes ]
    Measures body temperature

  • Peak subjective units of distress (SUD) [ Time Frame: Peak value from measurements made every 60 to 90 minutes up to eight hours during experimental session ] [ Designated as safety issue: Yes ]
    Single item self-report degree of distress

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Preparatory session ] [ Designated as safety issue: Yes ]
    Measures suicidal ideation and behavior ("suicidality")

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Experimental session - predrug ] [ Designated as safety issue: Yes ]
    Measures suicidal ideation and behavior ("suicidality")

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Experimental session - postdrug ] [ Designated as safety issue: Yes ]
    Measures suicidal ideation and behavior ("suicidality")

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Each of three integrative sessions ] [ Designated as safety issue: Yes ]
    Measures suicidal ideation and behavior ("suicidality")

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Two months post session ] [ Designated as safety issue: Yes ]
    Measures suicidal ideation and behavior ("suicidality")

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 months post session ] [ Designated as safety issue: Yes ]
    Measures suicidal ideation and behavior ("suicidality")

  • States of Consciousness Questionnaire (SCQ) [ Time Frame: Post experimental session ] [ Designated as safety issue: No ]
    Assesses nature of alteration in consciousness and completed soon after experimental session (day of to next day)

  • Peak diastolic blood pressure [ Time Frame: Peak from measurements taken every 15 to 30 minutes up through 8 h during experimental session ] [ Designated as safety issue: Yes ]
    Measures diastolic blood pressure


Estimated Enrollment: 3
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental session
125 and 62.5 mg MDMA and psychotherapy
 Drug: 3,4-methylenedioxymethamphetmine (MDMA)
125 mg MDMA followed by 62.5 mg 1.5 to 2.5 hours later

Detailed Description:

This study will investigate the effects of an additional 3,4-methylenedioxymethamine (MDMA)-assisted psychotherapy session in up to three participants with PTSD who relapsed after their PTSD symptoms had significantly decreased during MAPS' initial U.S. Phase 2 trial testing the use of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder PTSD). This new protocol will consist of a single, full-dose open-label session of MDMA-assisted psychotherapy, along with associated non-drug preparation and integrative psychotherapy sessions.

MDMA is an investigational drug that was studied in a randomized, placebo-controlled study in 21 participants, and it included a final evaluation of symptoms at least one year after taking part in the study. While PTSD symptoms in most study subjects stayed at the same levels from when they completed the study, symptoms had returned in a few people. This open-label study is intended to see if an additional MDMA-assisted session conducted at least 14 months after the first sessions can help reduce PTSD symptoms.

The MDMA-assisted psychotherapy session will be conducted by a male and female co-therapist team, one a psychiatrist and the other a psychiatric nurse. Vital signs (blood pressure, pulse and body temperature) and psychological distress will be measured throughout the experimental session. After the experimental session they will spend the night in the clinic with an attendant on duty, and complete a measure of alterations in consciousness, the States of Consciousness Questionnaire (SCQ) on the evening or day following the experimental session. Participants will meet with the investigators the next morning for an integrative psychotherapy session before leaving the clinic. During integrative psychotherapy sessions they will receive support in integrating their experiences and insights from the MDMA-assisted psychotherapy session. There will be daily phone contact with one of the investigators for 7 days after the experimental session. Symptoms of PTSD, depression and general function will be assessed two months after the experimental session. There will be a long-term follow up with repeated outcome measures 12 months after the experimental session

  Eligibility

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

Inclusion Criteria:

  • Meet DSM-IV diagnosis for PTSD
  • Have a Clinician Administered PTSD Scale (CAPS) score of at least 50
  • Have taken part in and completed initial study of MDMA-assisted psychotherapy for PTSD in the US (MAPS study MP-1) and met all study criteria
  • If in ongoing psychotherapy, may not change therapists, increase the frequency of therapy or commence any new type of therapy until after the evaluation session 2 months after the experimental session.
  • Refrain from taking any psychiatric medications starting at baseline until at least 10 days after the MDMA-assisted psychotherapy, and not to start any new psychiatric medication until two months after the MDMA-assisted session.
  • Must be willing to follow all study rules for behavior prior to, during and after the study session
  • Be willing to remain overnight at the study site and agree to have someone else transport them from site on the day after the session
  • Willing to be contacted for a week after the session via telephone
  • Negative pregnancy screen and willing to sue effective birth control
  • Must not participate in any other interventional clinical trials during the duration of this study.

Exclusion Criteria:

  • Developed any of the contraindicated psychiatric or medical conditions (psychosis, bipolar affective disorder, major heart or liver disease, etc) that would exclude participation in the original study
  • Have hypertension, unless hypertension is currently well-controlled on antihypertensive medicines, but only if they pass additional screening to rule out underlying cardiovascular disease
  • Being pregnant or lactating
  • Weigh less than 48 kg (106 lb)
  • Would present serious suicide risk as measured form interviewer or serious risk of harm to others
  • Require ongoing medication with a psychiatric drug
  • Meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days
  • Are unable to give adequate consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458327

Locations
United States, South Carolina
Offices of Michael Mithoefer
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Michael C Mithoefer, MD Psychiatrist
  More Information

No publications provided

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01458327     History of Changes
Other Study ID Numbers: MP1-E2
Study First Received: October 12, 2011
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
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 May 16, 2013