MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer

• ClinicalTrials.gov Identifier: NCT00252174
• Recruitment Status: Terminated
• First Posted: November 11, 2005
• Results First Posted: May 5, 2017
• Last Update Posted: November 14, 2017
• Sponsor: Brigham and Women's Hospital
• Collaborator: Mclean Hospital
• Information provided by (Responsible Party): John H. Halpern, MD, Mclean Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Conditions: Anxiety Disorder; Cancer
• Interventions: Drug: Stage 1 Active Methylenedioxymethamphetamine; Drug: Stage 1 Low dose Methylenedioxymethamphetamine; Behavioral: Psychotherapy; Drug: Stage 2 Active Methylenedioxymethamphetamine
• Enrollment: 2

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Period Title: Overall Study
Started	0 [1]	2 [2]	0 [3]
Completed	0	1	0
Not Completed	0	1	0
Reason Not Completed
Withdrawal by Subject	0	1	0
[1] No subjects were randomized into Active Arm as only 2 subjects were randomized into the Control Arm.; [2] 2 subjects entered the control arm in total; [3] No subjects entered Stage 2

Baseline Characteristics

Arm/Group Title		Stage 1, Active	Stage 1, Control	Stage 2, Active	Total
Arm/Group Description		8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	Total of all reporting groups
Overall Number of Baseline Participants		0	2	0	2
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	2 participants	0 participants	2 participants
	<=18 years		0 0.0%		0 0.0%
	Between 18 and 65 years		0 0.0%		0 0.0%
	>=65 years		2 100.0%		2 100.0%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	0 participants	2 participants	0 participants	2 participants
			66; (65 to 67)		66; (65 to 67)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	2 participants	0 participants	2 participants
	Female		0 0.0%		0 0.0%
	Male		2 100.0%		2 100.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	2 participants	0 participants	2 participants
	Hispanic or Latino		0 0.0%		0 0.0%
	Not Hispanic or Latino		2 100.0%		2 100.0%
	Unknown or Not Reported		0 0.0%		0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	2 participants	0 participants	2 participants
	American Indian or Alaska Native		0 0.0%		0 0.0%
	Asian		0 0.0%		0 0.0%
	Native Hawaiian or Other Pacific Islander		0 0.0%		0 0.0%
	Black or African American		0 0.0%		0 0.0%
	White		2 100.0%		2 100.0%
	More than one race		0 0.0%		0 0.0%
	Unknown or Not Reported		0 0.0%		0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	0 participants	2 participants	0 participants	2 participants
			2		2

Outcome Measures

1. Primary Outcome

Title	Spielberger State-Trait Anxiety Inventory (STAI)
Description	Established self-report measure of anxiety containing a State and Trait subscale and scored on a four-point Likert scale. Scores for each subscale range from 10 to 40 and combined from 20 to 80 with higher scores indicative of greater anxiety.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Primary Outcome

Title	Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description	Self-report instrument assessing quality of life with five functional scales, and nine symptom scales. Higher functional scores indicate better quality of life and higher symptom scores indicate poorer quality of life. Scales include "Yes" / "No" responses and four-point Likert scales, with transformations performed on scores so that all scale scores range from 0 to 100.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Anxiety - Hamilton Anxiety Rating Scale (HAM-A)
Description	standardized assessment of anxiety
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Quality of Life - Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (FACIT-Sp),Karnofsky Performance Rating Scale (KPRS), Memorial Symptom Assessment Scale (MSAS), Mini-Mental Status Exam (MMSE), Self-Expansiveness Level Form
Description	paper pencil tests capturing data on spiritual well-being, overall functioning living with cancer, psychiatric mental status, and on spiritual self-perception.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Hamilton Depression Rating Scale (HAM-D)
Description	Standardized interview assessing of depression, with higher scores indicative of greater depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD)
Description	standardized questions to evaluate extent of depression and thoughts of death.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Daily Use of Anxiolytics - Daily Diary
Description	daily log of anxiolytic medication usage.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	Daily Experience of Pain - Visual Analog Pain Scale (VAPS)
Description	daily measure of self-reported pain.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	The Hospital Anxiety and Depression Scale (HADS)
Description	Standardized assessment of anxiety and depression consisting of a 7-item anxiety scale and a 7-item depression scale. Each scale score ranges from 0 to 21, with 0-7 being "normal" and 11-21 being "abnormal" [e.g. severely depressed or anxious]
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS)
Description	Daily self-report measure for anxiety.
Time Frame	Obtained over the 3 months of active participation

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

11. Secondary Outcome

Title	Beck Hopelessness Scale (BHI)
Description	Established self-report measure of depression and hopelessness, consisting of 20 true-false questions, with scores ranging from 0 to 20, with scores of 0-3 indicating minimal hopelessness and scores of 15-20 severe hopelessness.
Time Frame	Obtained over 3 months of study

Outcome Measure Data

Analysis Population Description

Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material

Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description:	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Stage 1, Active	Stage 1, Control	Stage 2, Active
Arm/Group Description	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
All-Cause Mortality
	Stage 1, Active	Stage 1, Control	Stage 2, Active
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/2 (0.00%)	0/0
Serious Adverse Events
	Stage 1, Active	Stage 1, Control	Stage 2, Active
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/2 (0.00%)	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Stage 1, Active	Stage 1, Control	Stage 2, Active
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/2 (0.00%)	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: John H. Halpern, M.D.
• Organization: McLean Hospital at time of study
• Phone: 6179065063
• EMail: jhalpern@recoverycoa.com

• Responsible Party: John H. Halpern, MD, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT00252174
• Other Study ID Numbers: 76,770
• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Results First Submitted: January 20, 2017
• Results First Posted: May 5, 2017
• Last Update Posted: November 14, 2017