Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel

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: 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
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 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)
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
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
Number Analyzed 3 participants 2 participants 5 participants
45.6
(32 to 66)
39
(36 to 42)
43
(32 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
2
 100.0%
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month 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. It contains symptom subscales, a CAPS-IV 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 to two months after second MDMA-assisted experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured. All available data were reported.
Arm/Group Title Full Dose (125 mg) Low Dose (25 mg)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.5  (4.95) -7  (18.38)
2.Secondary Outcome
Title Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 6-month 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. It contains symptom subscales, a CAPS-IV 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 to 6 months after second MDMA-assisted experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured. All available data were reported.
Arm/Group Title Full Dose (125 mg) Low Dose (25 mg)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
-.05  (6.37) 6  (0)
3.Secondary Outcome
Title Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 12-month 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. It contains symptom subscales, a CAPS-IV 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 to twelve months after second MDMA-assisted experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured. All available data were reported.
Arm/Group Title Full Dose (125 mg) Low Dose (25 mg)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
-7.5  (13.43)
Time Frame From informed consent to study termination after 12 month follow up
Adverse Event Reporting Description This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
 
Arm/Group Title Full Dose (125 mg) MDMA-assisted Therapy Low Dose (25 mg) MDMA-assisted Therapy
Hide Arm/Group Description

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.

All-Cause Mortality
Full Dose (125 mg) MDMA-assisted Therapy Low Dose (25 mg) MDMA-assisted Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
Hide Serious Adverse Events
Full Dose (125 mg) MDMA-assisted Therapy Low Dose (25 mg) MDMA-assisted Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Full Dose (125 mg) MDMA-assisted Therapy Low Dose (25 mg) MDMA-assisted Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/2 (100.00%) 
Gastrointestinal disorders     
Vomiting *  1/3 (33.33%)  0/2 (0.00%) 
Flatulence *  1/3 (33.33%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders     
Fasciculation *  1/3 (33.33%)  1/2 (50.00%) 
Myoclonus *  0/3 (0.00%)  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders     
Viral upper respiratory tract infection *  0/3 (0.00%)  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
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 Corp.
Phone: (831) 429-6362
EMail: juliewang@mapsbcorp.com
Layout table for additonal information
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