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A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

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: NCT03537014
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : September 16, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Interventions Behavioral: Therapy
Drug: MDMA
Drug: Placebo
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MDMA-assisted Therapy Placebo With Therapy
Hide Arm/Group Description

Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.

Administration of inactive placebo in combination with psychotherapy

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy

Period Title: Overall Study
Started 46 45
Withdrew Consent Before Dosing 0 1
Completed First Experimental Session 46 44
Completed Second Experimental Session 43 41
Completed [1] 42 40
Not Completed 4 5
[1]
Completed Primary Endpoint
Arm/Group Title MDMA-assisted Therapy Placebo With Therapy Total
Hide Arm/Group Description

Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.

Administration of inactive placebo in combination with psychotherapy

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy

Total of all reporting groups
Overall Number of Baseline Participants 46 44 90
Hide Baseline Analysis Population Description
Safety set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 44 participants 90 participants
43.5  (12.9) 38.2  (10.4) 41.0  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Female
27
  58.7%
32
  72.7%
59
  65.6%
Male
19
  41.3%
12
  27.3%
31
  34.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Hispanic or Latino
5
  10.9%
3
   6.8%
8
   8.9%
Not Hispanic or Latino
41
  89.1%
40
  90.9%
81
  90.0%
Unknown or Not Reported
0
   0.0%
1
   2.3%
1
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
American Indian or Alaska Native
3
   6.5%
0
   0.0%
3
   3.3%
Asian
2
   4.3%
5
  11.4%
7
   7.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   4.5%
2
   2.2%
White
39
  84.8%
30
  68.2%
69
  76.7%
More than one race
2
   4.3%
6
  13.6%
8
   8.9%
Unknown or Not Reported
0
   0.0%
1
   2.3%
1
   1.1%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 46 participants 44 participants 90 participants
26.0  (4.8) 24.8  (4.2) 25.4  (4.5)
Duration of PTSD  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 44 participants 90 participants
14.8  (11.6) 13.2  (11.4) 14.1  (11.5)
Dissociative subtype of PTSD  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
6
  13.0%
13
  29.5%
19
  21.1%
1.Primary Outcome
Title Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)
Hide Description The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. 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 to 18 weeks post enrollment confirmation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title MDMA-assisted Therapy Placebo With Therapy
Hide Arm/Group Description:

Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.

Administration of inactive placebo in combination with psychotherapy

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy

Overall Number of Participants Analyzed 42 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
-24.4  (11.6) -13.9  (11.5)
2.Secondary Outcome
Title Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS) Total Score
Hide Description The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment that was adapted for the purposes of this study to limit missing item-level data as per the FDA requirements and included use of the three-item mean as the total score and imputation of work-related impairment. The SDS is a 3-item scale measuring the severity of disability in the domains of work, family life/home responsibilities and social/leisure activities, with each item scored on a ten-point Likert scale from 0 ('not at all impaired') to 10 ('very severely impaired'). The SDS total score was the mean of the 3 item responses. The SDS total score ranged from 0 to 10, with higher scores indicating greater functional impairment.
Time Frame Baseline to 18 weeks post enrollment confirmation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title MDMA-assisted Therapy Placebo With Therapy
Hide Arm/Group Description:

Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.

Administration of inactive placebo in combination with psychotherapy

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy

Overall Number of Participants Analyzed 42 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.1  (2.6) -2.0  (2.4)
Time Frame From Baseline to end of study (approximately 5 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MDMA-assisted Therapy Placebo With Therapy
Hide Arm/Group Description

Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.

Administration of inactive placebo in combination with psychotherapy

Psychotherapy: Standardized non-directive psychotherapy performed by therapist team

Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy

All-Cause Mortality
MDMA-assisted Therapy Placebo With Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)      0/44 (0.00%)    
Hide Serious Adverse Events
MDMA-assisted Therapy Placebo With Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      2/44 (4.55%)    
Psychiatric disorders     
Suicidal Behavior *  0/46 (0.00%)  1/44 (2.27%)  2
Suicidal Ideation *  0/46 (0.00%)  1/44 (2.27%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MDMA-assisted Therapy Placebo With Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/46 (100.00%)      44/44 (100.00%)    
Cardiac disorders     
Palpitations *  4/46 (8.70%)  6/44 (13.64%) 
Ear and labyrinth disorders     
Ear Pain *  3/46 (6.52%)  0/44 (0.00%) 
Vertigo *  3/46 (6.52%)  2/44 (4.55%) 
Eye disorders     
Mydriasis *  7/46 (15.22%)  0/44 (0.00%) 
Vision Blurred *  4/46 (8.70%)  1/44 (2.27%) 
Gastrointestinal disorders     
Abdominal Discomfort *  6/46 (13.04%)  3/44 (6.82%) 
Abdominal Pain Upper *  7/46 (15.22%)  4/44 (9.09%) 
Diarrhea *  4/46 (8.70%)  5/44 (11.36%) 
Dry Mouth *  5/46 (10.87%)  2/44 (4.55%) 
Nausea *  21/46 (45.65%)  10/44 (22.73%) 
Vomiting *  5/46 (10.87%)  0/44 (0.00%) 
General disorders     
Asthenia *  7/46 (15.22%)  4/44 (9.09%) 
Chills *  3/46 (6.52%)  9/44 (20.45%) 
Crying *  0/46 (0.00%)  3/44 (6.82%) 
Fatigue *  18/46 (39.13%)  16/44 (36.36%) 
Feeling Cold *  9/46 (19.57%)  3/44 (6.82%) 
Feeling Hot *  4/46 (8.70%)  4/44 (9.09%) 
Feeling Jittery *  6/46 (13.04%)  0/44 (0.00%) 
Influenza Like Illness *  4/46 (8.70%)  4/44 (9.09%) 
Non-Cardiac Chest Pain *  5/46 (10.87%)  1/44 (2.27%) 
Pain *  5/46 (10.87%)  5/44 (11.36%) 
Pyrexia *  3/46 (6.52%)  1/44 (2.27%) 
Temperature Intolerence *  4/46 (8.70%)  2/44 (4.55%) 
Feeling Abnormal *  3/46 (6.52%)  1/44 (2.27%) 
Feeling of Body Temperature Change *  4/46 (8.70%)  1/44 (2.27%) 
Infections and infestations     
Upper Respiratory Tract Infection *  6/46 (13.04%)  4/44 (9.09%) 
Viral Upper Respiratory Tract Infection *  12/46 (26.09%)  6/44 (13.64%) 
Influenza *  3/46 (6.52%)  0/44 (0.00%) 
Investigations     
Blood Pressure Increased *  6/46 (13.04%)  0/44 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite *  24/46 (52.17%)  5/44 (11.36%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  5/46 (10.87%)  5/44 (11.36%) 
Back Pain *  7/46 (15.22%)  4/44 (9.09%) 
Muscle Tightness *  30/46 (65.22%)  6/44 (13.64%) 
Muscle Twitching *  3/46 (6.52%)  0/44 (0.00%) 
Musculoskeletal Pain *  4/46 (8.70%)  0/44 (0.00%) 
Neck Pain *  3/46 (6.52%)  3/44 (6.82%) 
Pain in Jaw *  4/46 (8.70%)  3/44 (6.82%) 
Muscle Spasms *  3/46 (6.52%)  2/44 (4.55%) 
Myalgia *  3/46 (6.52%)  1/44 (2.27%) 
Nervous system disorders     
Disturbance in Attention *  5/46 (10.87%)  6/44 (13.64%) 
Dizziness *  11/46 (23.91%)  6/44 (13.64%) 
Dizziness Postural *  6/46 (13.04%)  2/44 (4.55%) 
Headache *  34/46 (73.91%)  25/44 (56.82%) 
Hypoaesthesia *  3/46 (6.52%)  2/44 (4.55%) 
Nystagmus *  6/46 (13.04%)  0/44 (0.00%) 
Paraesthesia *  6/46 (13.04%)  4/44 (9.09%) 
Somnolence *  4/46 (8.70%)  0/44 (0.00%) 
Tremor *  6/46 (13.04%)  3/44 (6.82%) 
Psychiatric disorders     
Agitation *  4/46 (8.70%)  3/44 (6.82%) 
Anger *  6/46 (13.04%)  6/44 (13.64%) 
Anxiety *  22/46 (47.83%)  25/44 (56.82%) 
Bruxism *  6/46 (13.04%)  2/44 (4.55%) 
Depressed Mood *  6/46 (13.04%)  6/44 (13.64%) 
Depression *  4/46 (8.70%)  4/44 (9.09%) 
Emotional Disorder *  4/46 (8.70%)  4/44 (9.09%) 
Flashback *  3/46 (6.52%)  3/44 (6.82%) 
Insomnia *  29/46 (63.04%)  20/44 (45.45%) 
Intentional Self-Injury *  1/46 (2.17%)  5/44 (11.36%) 
Intrusive Thoughts *  4/46 (8.70%)  0/44 (0.00%) 
Irritability *  7/46 (15.22%)  10/44 (22.73%) 
Nervousness *  3/46 (6.52%)  0/44 (0.00%) 
Nightmare *  8/46 (17.39%)  12/44 (27.27%) 
Restlnessness *  7/46 (15.22%)  0/44 (0.00%) 
Stress *  4/46 (8.70%)  0/44 (0.00%) 
Suicidal Ideation *  22/46 (47.83%)  23/44 (52.27%) 
Dissociation *  2/46 (4.35%)  3/44 (6.82%) 
Emotional Distress *  2/46 (4.35%)  3/44 (6.82%) 
Panic Attack *  2/46 (4.35%)  3/44 (6.82%) 
Renal and urinary disorders     
Micturition Urgency *  3/46 (6.52%)  0/44 (0.00%) 
Pollakiuria *  4/46 (8.70%)  1/44 (2.27%) 
Reproductive system and breast disorders     
Dysmenorrhoea *  3/46 (6.52%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal Pain *  2/46 (4.35%)  3/44 (6.82%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis *  10/46 (21.74%)  1/44 (2.27%) 
Social circumstances     
Substance Use *  3/46 (6.52%)  0/44 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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: NCT03537014    
Other Study ID Numbers: MAPP1
First Submitted: May 14, 2018
First Posted: May 25, 2018
Results First Submitted: August 18, 2021
Results First Posted: September 16, 2021
Last Update Posted: November 11, 2021