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Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With 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: NCT01958593
Recruitment Status : Terminated (This pilot study was terminated early by sponsor due to insufficient rate of accrual.)
First Posted : October 9, 2013
Results First Posted : August 2, 2021
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Brief Summary:
This small ("pilot") study is designed to provide information on whether the combination of psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress disorder (PTSD). The researchers will use the results of this study to design more studies of this treatment. The study compares a comparator (placebo) and a full dose. For each session, there will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the size of the initial dose. The study will measure symptoms of PTSD, depression, general psychological well-being, sleep quality, feelings that the self or world is unreal (dissociation), potentially positive effects of surviving traumatic events and cognitive function (thinking, memory and attention). People experiencing pain or tinnitus (ringing in the ears) will record their symptoms throughout the study. Seven people will be randomly (by chance) assigned to receive full-dose MDMA and five will be randomly assigned to receive a comparator. There will be three preparatory psychotherapy sessions before the first experimental session, and subjects will have supportive or "integrative" sessions after each MDMA-assisted psychotherapy session. Subjects will meet with a male and female psychotherapist for all experimental sessions and for sessions before and after each experimental session. Subjects who received comparator can enroll in Stage 2, where they will have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know they are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have a third experimental session.. Symptoms of PTSD and other symptoms will be measured again at least 12 months after each subject has started the study.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Placebo Drug: 3,4-methylenedioxymethamphetamine Behavioral: Psychotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) - Canada
Study Start Date : September 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Comparator
Participants will receive placebo during each of two experimental sessions.
Drug: Placebo
Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment
Other Name: Inactive placaebo

Behavioral: Psychotherapy
Psychotherapy before and after experimental sessions

Experimental: 3,4-methylenedioxymethamphetamine
Participants will receive full-dose MDMA during each of two experimental sessions.
Drug: 3,4-methylenedioxymethamphetamine
Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.
Other Names:
  • 3,4-methyelenedioxymethamphetamine
  • MDMA

Behavioral: Psychotherapy
Psychotherapy before and after experimental sessions




Primary Outcome Measures :
  1. Change in Clinician-Administered PTSD Scale (CAPS-IV) Score [ Time Frame: 0 to 3 months post enrollment ]
    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscale scores. The Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-4. It contains symptom subscales, a CAPS-4 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 from CAPS administered at Baseline to primary endpoint 1 month after 2nd experimental session



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with PTSD, duration of six months or longer
  • Have a CAPS score showing moderate to severe PTSD symptoms;
  • Have had 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;
  • 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

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): NCT01958593


Locations
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Canada, British Columbia
Offices of Dr. Ingrid Pacey MBBS FRCP[C]
Vancouver, British Columbia, Canada, V6R 1N6
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
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Principal Investigator: Ingrid Pacey, MBBS FRCP[C] University of Victoria
  Study Documents (Full-Text)

Documents provided by Multidisciplinary Association for Psychedelic Studies:
Study Protocol  [PDF] June 20, 2014
Statistical Analysis Plan  [PDF] May 31, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01958593    
Other Study ID Numbers: MP-4
First Posted: October 9, 2013    Key Record Dates
Results First Posted: August 2, 2021
Last Update Posted: April 4, 2022
Last Verified: March 2022
Keywords provided by Multidisciplinary Association for Psychedelic Studies:
PTSD
Posttraumatic stress disorder
MDMA
psychotherapy
Additional relevant MeSH terms:
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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