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Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

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ClinicalTrials.gov Identifier: NCT03485287
Recruitment Status : Completed
First Posted : April 2, 2018
Results First Posted : July 1, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Interventions Drug: MDMA
Behavioral: Therapy
Enrollment 4
Recruitment Details Participants will be recruited through print and internet advertisements, referrals from other psychiatrists, psychotherapists, or physicians, and by word of mouth.
Pre-assignment Details  
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Period Title: Overall Study
Started 4
Completed 3
Not Completed 1
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Safety Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
29.25  (5.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
1
  25.0%
Not Hispanic or Latino
3
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  25.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Baseline BMI Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Normal
3
  75.0%
Overweight/Obese
1
  25.0%
Baseline BMI Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Normal
3
  75.0%
Overweight/Obese
1
  25.0%
Duration of PTSD  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 4 participants
7.93  (6.15)
Disabled from Work  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Yes
1
  25.0%
No
3
  75.0%
1.Primary Outcome
Title Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Hide Description The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
Time Frame Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description:
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
-25.00  (2.58)
2.Primary Outcome
Title Baseline Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Scores
Hide Description The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
Time Frame Baseline (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description:
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
45.3  (11.84)
3.Primary Outcome
Title Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Hide Description The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
Time Frame Visit 19 (18 weeks post-enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description:
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
20.25  (9.98)
4.Secondary Outcome
Title Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score
Hide Description The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.
Time Frame Baseline (Visit 3) to Primary Endpoint (Visit 19, 18 weeks post-enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description:
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
-4.7  (1.46)
5.Secondary Outcome
Title Baseline Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score
Hide Description The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.
Time Frame Baseline (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description:
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.4  (1.6)
6.Secondary Outcome
Title Primary Endpoint Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score
Hide Description The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.
Time Frame Visit 19 (18 weeks post-enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description:
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.8  (3.41)
Time Frame During the Treatment Period from the first Experimental Session through the last Integrative Session (3-4 weeks post last dose).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MDMA-assisted Therapy (100 to 125 mg of MDMA)
Hide Arm/Group Description Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
All-Cause Mortality
MDMA-assisted Therapy (100 to 125 mg of MDMA)
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Serious Adverse Events
MDMA-assisted Therapy (100 to 125 mg of MDMA)
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MDMA-assisted Therapy (100 to 125 mg of MDMA)
Affected / at Risk (%)
Total   4/4 (100.00%) 
Cardiac disorders   
Palpitations *  2/4 (50.00%) 
Gastrointestinal disorders   
Diarrhea *  1/4 (25.00%) 
Aphtous ulcer *  1/4 (25.00%) 
Nausea *  2/4 (50.00%) 
Vomiting *  1/4 (25.00%) 
General disorders   
Fatigue *  2/4 (50.00%) 
Feeling cold *  1/4 (25.00%) 
Viral upper respiratory tract infection *  1/4 (25.00%) 
Injury, poisoning and procedural complications   
Fracture *  1/4 (25.00%) 
Laceration *  1/4 (25.00%) 
Ligament sprain *  1/4 (25.00%) 
Metabolism and nutrition disorders   
Decreased appetite *  1/4 (25.00%) 
Musculoskeletal and connective tissue disorders   
Muscle tightness *  1/4 (25.00%) 
Pain in extremity *  1/4 (25.00%) 
Nervous system disorders   
Dizziness *  2/4 (50.00%) 
Headache *  3/4 (75.00%) 
Paraesthesia *  1/4 (25.00%) 
Sensory disturbance *  1/4 (25.00%) 
Syncope *  2/4 (50.00%) 
Depressed mood *  1/4 (25.00%) 
Psychiatric disorders   
Aggression *  1/4 (25.00%) 
Anxiety *  3/4 (75.00%) 
Depression *  1/4 (25.00%) 
Derealisation *  1/4 (25.00%) 
Insomnia *  2/4 (50.00%) 
Nightmare *  2/4 (50.00%) 
Suicidal ideation *  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain *  1/4 (25.00%) 
Vascular disorders   
Peripheral coldness *  1/4 (25.00%) 
*
Indicates events were collected by non-systematic assessment
This was an open-label trial with no placebo comparator in a small sample size (n=4).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie B. Wang, MPH, PhD/ Senior Clinical Data Scientist
Organization: Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation
Phone: (831) 429-6362
EMail: juliewang@mapsbcorp.com
Layout table for additonal information
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT03485287    
Other Study ID Numbers: MP-17
First Submitted: March 23, 2018
First Posted: April 2, 2018
Results First Submitted: May 25, 2021
Results First Posted: July 1, 2021
Last Update Posted: September 27, 2021