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Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

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ClinicalTrials.gov Identifier: NCT01689740
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : October 30, 2020
Last Update Posted : June 29, 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 (PTSD)
Interventions Drug: Active Placebo Dose MDMA (25 mg)
Drug: Full Dose MDMA (125 mg)
Drug: Open Label Full Dose MDMA (125 mg)
Behavioral: Psychotherapy
Enrollment 10
Recruitment Details Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, through the Israeli Defense Forces (IDF) and through word of mouth.
Pre-assignment Details  
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA and Psychotherapy Full Dose MDMA and Psychotherapy
Hide Arm/Group Description

Open label: Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.

125 mg MDMA (open label): Initial dose of MDMA administered orally at the start of each of two psychotherapy sessions, supplement administered 1.5 to 2.5 hours later.

Psychotherapy: Psychotherapy provided throughout course of main study

Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Active placebo dose MDMA: Initial dose of 25 mg MDMA administered orally at the start of each of two separate psychotherapy sessions scheduled three to five weeks apart possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.

Psychotherapy: Psychotherapy provided throughout course of main study

Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Full dose MDMA: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions scheduled three to five weeks apart. In each case, it may be followed 1.5 to 2.5 hours later with 62.5 mg MDMA.

Psychotherapy: Psychotherapy provided throughout course of main study

Period Title: Overall Study
Started 2 3 5
Completed 2 3 5
Not Completed 0 0 0
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy Total
Hide Arm/Group Description Participants receive open MDMA with an initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions. Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart. Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart. Total of all reporting groups
Overall Number of Baseline Participants 2 3 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
3
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants 10 participants
Female
1
  50.0%
0
   0.0%
3
  60.0%
4
  40.0%
Male
1
  50.0%
3
 100.0%
2
  40.0%
6
  60.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 2 participants 3 participants 5 participants 10 participants
White/Caucasian
2
 100.0%
2
  66.7%
5
 100.0%
9
  90.0%
Middle Eastern
0
   0.0%
1
  33.3%
0
   0.0%
1
  10.0%
1.Primary Outcome
Title Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1
Hide Description The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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 1-Month Post Experimental Session 2 (End of Stage 1)
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Intent-to-Treat (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-42.0  (9.90) -9.0  (15.62) -34.6  (16.29)
2.Secondary Outcome
Title Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2
Hide Description The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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 End of Stage 1 to End of Stage 2
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover
Hide Arm/Group Description:

Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
-10.0  (4.24)
3.Secondary Outcome
Title Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up
Hide Description The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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 12 months post-final experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-39.0  (14.14) -34.5  (20.51) -48.8  (20.39)
4.Secondary Outcome
Title Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1
Hide Description Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Time Frame Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-17.0  (2.83) 0.33  (4.73) -17.0  (12.59)
5.Secondary Outcome
Title Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2
Hide Description Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Time Frame End of Stage 1 to End of Stage 2
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover
Hide Arm/Group Description:

Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.0  (1.41)
6.Secondary Outcome
Title Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up
Hide Description Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Time Frame Baseline to 12 month post-final experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-17.0  (5.66) -3.5  (4.95) -18.4  (11.10)
7.Secondary Outcome
Title Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1
Hide Description The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Time Frame Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
15.0  (21.21) -2.33  (8.74) 18.2  (11.14)
8.Secondary Outcome
Title Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2
Hide Description The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Time Frame End of Stage 1 to End of Stage 2
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover
Hide Arm/Group Description:

Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.5  (2.12)
9.Secondary Outcome
Title Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up
Hide Description The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Time Frame Baseline to 12 months post-final experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
5  (7.07) -2.0  (4.24) 26.6  (10.33)
10.Secondary Outcome
Title Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1
Hide Description The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Time Frame Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-19.0  (5.66) 1.33  (13.43) -17.4  (9.91)
11.Secondary Outcome
Title Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2
Hide Description The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Time Frame End of Stage 1 to End of Stage 2
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover
Hide Arm/Group Description:

Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
-10.0  (7.07)
12.Secondary Outcome
Title Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up
Hide Description The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Time Frame Baseline to 12 months post-final experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-23.0  (0) -10  (9.90) -20.4  (12.7)
13.Secondary Outcome
Title Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1
Hide Description The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Time Frame Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-7.5  (6.36) 1.0  (5.29) -1.8  (4.44)
14.Secondary Outcome
Title Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2
Hide Description The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Time Frame End of Stage 1 to End of Stage 2
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover
Hide Arm/Group Description:

Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.

Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg.

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.5  (3.54)
15.Secondary Outcome
Title Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up
Hide Description The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Time Frame Baseline to 12 months post-final experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set (ITT)
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description:
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
Overall Number of Participants Analyzed 2 3 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.5  (3.54) -2.0  (4.24) -2.2  (5.40)
Time Frame All AEs for all subjects across the entire study period of approximately 18 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Hide Arm/Group Description Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions. Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart. Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
All-Cause Mortality
Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Hide Serious Adverse Events
Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lead in: 125 mg MDMA (Open Label) and Psychotherapy Active Placebo Dose MDMA (25 mg) and Psychotherapy Full Dose MDMA (125 mg) and Psychotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)   2/3 (66.67%)   5/5 (100.00%) 
Gastrointestinal disorders       
Nausea *  0/2 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Intestinal obstruction *  0/2 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
General disorders       
Pyrexia *  1/2 (50.00%)  0/3 (0.00%)  1/5 (20.00%) 
Infections and infestations       
Influenza *  0/2 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Upper respiratory infection *  1/2 (50.00%)  0/3 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders       
Tremor *  0/2 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Nervous system disorders       
Headache *  0/2 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Dizziness *  0/2 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Psychiatric disorders       
Anxiety *  1/2 (50.00%)  0/3 (0.00%)  4/5 (80.00%) 
Insomnia *  1/2 (50.00%)  0/3 (0.00%)  0/5 (0.00%) 
Depression *  0/2 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Suicidal Ideation *  0/2 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Posttraumatic stress disorder *  0/2 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Anger *  0/2 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma *  1/2 (50.00%)  0/3 (0.00%)  0/5 (0.00%) 
Oropharyngeal pain *  1/2 (50.00%)  0/3 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders       
Hypersensitivity *  0/2 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Social circumstances       
Exposure to violent event *  0/2 (0.00%)  1/3 (33.33%)  0/5 (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 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 Corp.
Phone: (831) 429-6362
EMail: juliewang@mapsbcorp.com
Layout table for additonal information
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01689740    
Other Study ID Numbers: MP-9
First Submitted: September 7, 2012
First Posted: September 21, 2012
Results First Submitted: August 14, 2020
Results First Posted: October 30, 2020
Last Update Posted: June 29, 2021