ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 62 for:    MDMA

Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

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: NCT02102802
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Brief Summary:
This study measures biological and psychological processes that might help researchers to better understand what is taking place during low or medium dose and full dose MDMA-assisted psychotherapy treatment in people with PTSD. Heart rate variability (HRV) will be measured up to three times; before and once or twice after receiving MDMA-assisted psychotherapy. Brain activity will be measured before and after MDMA-assisted psychotherapy in response to personalized trauma-related scripts. Participants will complete a measure of self-compassion at baseline and two months after a final experimental treatment session. Therapy techniques observed during recorded treatment sessions will be classified using a standardized clinical measure.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Low or Medium dose MDMA Drug: Full dose MDMA Phase 2

Detailed Description:

PTSD is a complex psychiatric disease characterized by a deficit in fear extinction, hyperarousal, emotional numbing, and intrusive symptoms that cause the patient to persistently re-experience a traumatic event over a period longer than a month. PTSD is considered chronic when symptoms are present for at least six months. MDMA-assisted psychotherapy is an innovative experimental mode of treatment that combines psychotherapeutic techniques with the administration of MDMA. It may amplify certain aspects of psychotherapy, as the pharmacological action of MDMA is thought to act as an adjunct to psychotherapy. With positive results in two studies and ongoing Phase 2 clinical studies it is important to further characterize the psychotherapeutic processes that occur during treatment sessions conducted according to the manualized method of MDMA-assisted psychotherapy. Changes in physiological status or brain activity that are associated with improvement or recovery in people with chronic PTSD may offer a means of assessing treatment response that relies less on self-report. This may be particularly important in studies with MDMA-assisted psychotherapy where blinding is difficult due to the psychoactive nature of the investigational product. This study is also interested in identifying and categorizing psychotherapeutic processes taking place during MDMA-assisted psychotherapy. The sub-study will also examine elements of the experience with a self-report measure of self-compassion.

This exploratory sub-study will identify psychotherapeutic processes occurring during MDMA- assisted psychotherapy in people with chronic PTSD and assess the feasibility of exploring physiological correlates of clinical outcomes in subjects enrolled in the ongoing clinical trial of MDMA-assisted psychotherapy, NCT #: NCT01211405. The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College and the New School for Social Research.

To support the clinical outcomes measured by CAPS from the MP-8 study, the sponsor is interested in correlations of outcomes with treatment-related changes in potential biological markers of PTSD, measured by HRV and fMRI. Brain activity while listening to neutral and personalized trauma-related scripts will take place at baseline and after experimental MDMA-assisted psychotherapy with low or medium or full dose MDMA. The fMRI scan will be followed by a Diffusion Tensor Imaging (DTI) scan. After each scanning session, pulse measurements will be extracted as a digital data file from which HRV will be calculated. FMRI scans and HRV measurements will occur at baseline for participants in all conditions, one month after the second experimental session and again after a final experimental session for participants in the low or medium dose condition, and two months after the final experimental session for participants in the full dose condition. Participants will complete the Self-Compassion Scale, a self-report measure of self-compassion at Baseline and after the final MDMA-assisted psychotherapy session. Psychotherapeutic processes will be assessed via observing psychotherapy and sorting a set of 100 therapy-related items as a means of describing the interactions. Trained coders will observe at least one pre-drug psychotherapy session, one experimental (drug-assisted psychotherapy) session and one post-drug psychotherapy session.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exploring Mechanisms of Action of ±3,4-methylenedioxymethamphetamine (MDMA)- Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD)
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low or medium dose MDMA
Participants receive 30 mg MDMA possibly followed 1.5 to 2 h later by 15 mg or participants receive 75 mg MDMA possibly followed by 37.5 mg MDMA
Drug: Low or Medium dose MDMA
Participants receiving 30 or 75 mg MDMA
Other Names:
  • 3,4-methylenedioxymethamphetamine
  • MDMA

Experimental: Full dose MDMA
Participants will receive 125 mg MDMA possibly followed 1.5 to 2 h later by 62.5 mg MDMA
Drug: Full dose MDMA
Participants receiving 125 mg MDMA
Other Names:
  • 3,4-methylenedioxymethamphetamine
  • MDMA




Primary Outcome Measures :
  1. Change in brain activity measured via fMRI while listening to trauma scripts [ Time Frame: Baseline, two months after final experimental session ]
    Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts.


Secondary Outcome Measures :
  1. Change in heart rate variability in response to trauma script [ Time Frame: Baseline, one month post-drug ]
    Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD

  2. Change in Self Compassion Scale Score [ Time Frame: Baseline, one month post-drug ]
    Self-report measure of self-compassion

  3. Change in heart rate variability in response to trauma script [ Time Frame: Baseline, two months post final drug administration ]
    Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD

  4. Change in Self Compassion Scale Score [ Time Frame: Baseline, two months post final drug administration ]
    Self-report measure of self-compassion

  5. Change in brain activity measured via fMRI while listening to trauma scripts [ Time Frame: Baseline, one month post-drug ]
    Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts


Other Outcome Measures:
  1. Psychotherapy Process Q-set (PSQ) [ Time Frame: 3 - 7 weeks post enrollment ]
    System of coding psychotherapeutic processes in observed psychotherapy (pre-drug)

  2. Psychotherapy Process Q-set (PSQ) [ Time Frame: 8 - 16 weeks post-enrollment ]
    System of coding psychotherapeutic processes in observed psychotherapy (drug-assisted psychotherapy session)

  3. Psychotherapy Process Q-set (PSQ) [ Time Frame: 17-27 weeks post-enrollment ]
    System of coding psychotherapeutic processes in observed psychotherapy (end of treatment after final experimental session)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405

Exclusion Criteria:

  • Mass brain lesion
  • Have metal in their skulls,
  • Having brain or heart pacemakers
  • History of major head trauma
  • Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102802


Locations
United States, South Carolina
Offices of Michael Mithoefer
Mount Pleasant, South Carolina, United States, 29464-4345
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Michael C Mithoefer, MD Private practice

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT02102802     History of Changes
Other Study ID Numbers: MP8-S1
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: May 2017

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
PTSD
MDMA
Brain activity
fMRI
Heart rate variability
Physiological correlate

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