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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT01458327
First received: October 12, 2011
Last updated: February 10, 2016
Last verified: February 2016
  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:


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
Study Completion Date: February 2016
Primary Completion Date: May 2015 (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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be diagnosed with chronic PTSD;
  • Have a CAPS score showing moderate to severe PTSD symptoms;
  • Have participated in MP-1;
  • Are at least 18 years old;
  • Must be generally healthy;
  • Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
  • Are willing to refrain from taking any psychiatric medications during the study period;
  • Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
  • Willing to remain overnight at the study site;
  • Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
  • Are willing to be contacted via telephone for all necessary telephone contacts;
  • Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
  • must provide a contact in the event of a participant becoming suicidal;
  • Are proficient in speaking and reading English;
  • agree to have all clinic visit sessions recorded to audio and video
  • Agree not to participate in any other interventional clinical trials during the duration of this study.

Exclusion Criteria:

  • Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
  • Weigh less than 48 kg;
  • Are abusing illegal drugs;
  • Are unable to give adequate informed consent;
  • Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
  • Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.
  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: 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

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: February 10, 2016
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, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents

ClinicalTrials.gov processed this record on July 26, 2016