Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
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ClinicalTrials.gov Identifier: NCT00402298 |
Recruitment Status :
Terminated
(This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection.)
First Posted : November 22, 2006
Results First Posted : September 20, 2021
Last Update Posted : November 2, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Posttraumatic Stress Disorder |
Interventions |
Drug: 3,4-methylenedioxymethemphetmaine (MDMA_ Drug: 3,4-methylenedioxymethamphetamine |
Enrollment | 5 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Full Dose (125 mg) | Low Dose (25 mg) |
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Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions. 3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session. |
25 and 12.5 mg MDMA 3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions. |
Period Title: Overall Study | ||
Started | 3 | 2 |
Completed | 2 | 2 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 0 |
Arm/Group Title | Full Dose (125 mg) | Active Comparator (25 mg) | Total | |
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Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions. 3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session. |
25 and 12.5 mg MDMA 3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 2 | 5 | |
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This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data was reported to the sponsor and its quality could not be assured. We have updated the record to reflect the limited data received.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 2 participants | 5 participants | |
<=18 years | 0 | 0 | 0 | |
Between 18 and 65 years | 2 | 2 | 4 | |
>=65 years | 1 | 0 | 1 | |
Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 3 participants | 2 participants | 5 participants | |
45.6
(32 to 66)
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39
(36 to 42)
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43
(32 to 66)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 2 participants | 5 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
3 100.0%
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2 100.0%
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5 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Israel | Number Analyzed | 3 participants | 2 participants | 5 participants |
3 | 2 | 5 |
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 |
Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
ClinicalTrials.gov Identifier: | NCT00402298 |
Other Study ID Numbers: |
MP-3 |
First Submitted: | November 20, 2006 |
First Posted: | November 22, 2006 |
Results First Submitted: | August 23, 2021 |
Results First Posted: | September 20, 2021 |
Last Update Posted: | November 2, 2021 |