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

• ClinicalTrials.gov Identifier: NCT00402298
• Recruitment Status: Terminated
• First Posted: November 22, 2006
• Results First Posted: September 20, 2021
• Last Update Posted: November 2, 2021
• Sponsor: Multidisciplinary Association for Psychedelic Studies
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Full Dose (125 mg)	Low Dose (25 mg)
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

Baseline Characteristics

Arm/Group Title		Full Dose (125 mg)	Active Comparator (25 mg)	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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)

Adverse Events

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
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%)
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%)
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

Limitations and Caveats

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.

More Information

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

• 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