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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01458327
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE October 12, 2011
First Posted Date  ICMJE October 24, 2011
Last Update Posted Date June 16, 2021
Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
  • Clinician Administered PTSD Scale [ Time Frame: Two months post-session ]
    Measures PTSD symptoms
  • Clinician Administered PTSD Scale [ Time Frame: 12 months post session ]
    Measures PTSD symptoms
  • Clinician Administered PTSD Scale [ Time Frame: Prior to session ]
    Measures PTSD symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Prior to study session ]
    Self-report measure of PTSD symptoms
  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Two months post session ]
    Self-report measure of PTSD symptoms
  • Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 12 months post session ]
    Self-report measure of PTSD symptoms
  • Global Assessment of Functioning [ Time Frame: Prior to session ]
    Observer-rated assessment of general psychological function
  • Global Assessment of Functioning [ Time Frame: Two months post session ]
    Observer-rated assessment of general psychological function
  • Global Assessment of Functioning [ Time Frame: 12 months post sesssion ]
    Observer-rated assessment of general psychological function
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Prior to session ]
    Self-report measure of symptoms of depression
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Two months post session ]
    Self-report measure of symptoms of depression
  • Beck Depression Inventory II (BDI-II) [ Time Frame: 12 months post session ]
    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 ]
    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 ]
    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 ]
    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 ]
    Single item self-report degree of distress
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Preparatory session ]
    Measures suicidal ideation and behavior ("suicidality")
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Experimental session - predrug ]
    Measures suicidal ideation and behavior ("suicidality")
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Experimental session - postdrug ]
    Measures suicidal ideation and behavior ("suicidality")
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Each of three integrative sessions ]
    Measures suicidal ideation and behavior ("suicidality")
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Two months post session ]
    Measures suicidal ideation and behavior ("suicidality")
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 months post session ]
    Measures suicidal ideation and behavior ("suicidality")
  • States of Consciousness Questionnaire (SCQ) [ Time Frame: Post experimental session ]
    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 ]
    Measures diastolic blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Additional MDMA-assisted Psychotherapy for People Who Relapsed After MDMA-assisted Psychotherapy Trial
Official Title  ICMJE 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)
Brief Summary 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE
  • Drug: 3,4-methylenedioxymethamphetmine (MDMA)
    125 mg MDMA followed by 62.5 mg 1.5 to 2.5 hours later
  • Behavioral: Psychotherapy
    Psychotherapy in combination with MDMA
Study Arms  ICMJE Experimental: 3,4-methylenedoxymethamphetamine (MDMA) and psychotherapy
125 and 62.5 mg MDMA
Interventions:
  • Drug: 3,4-methylenedioxymethamphetmine (MDMA)
  • Behavioral: Psychotherapy
Publications * Not Provided

*   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: October 20, 2011)
3
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT01458327
Other Study ID Numbers  ICMJE MP1-E2
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: Michael C Mithoefer, MD Psychiatrist
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date February 2017

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