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

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: NCT00252174
Recruitment Status : Terminated (Lack of funds and insufficient patient population for study enrollment.)
First Posted : November 11, 2005
Results First Posted : May 5, 2017
Last Update Posted : November 14, 2017
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage 1, Active Stage 1, Control Stage 2, Active
Hide 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
Arm/Group Title Stage 1, Active Stage 1, Control Stage 2, Active Total
Hide 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
Hide 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
1.Primary Outcome
Title Spielberger State-Trait Anxiety Inventory (STAI)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description standardized assessment of anxiety
Time Frame Obtained over the 3 months of active participation
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description standardized questions to evaluate extent of depression and thoughts of death.
Time Frame Obtained over the 3 months of active participation
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description daily log of anxiolytic medication usage.
Time Frame Obtained over the 3 months of active participation
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description daily measure of self-reported pain.
Time Frame Obtained over the 3 months of active participation
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description Daily self-report measure for anxiety.
Time Frame Obtained over the 3 months of active participation
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stage 1, Active Stage 1, Control Stage 2, Active
Hide 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 
Hide 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 
Hide 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 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John H. Halpern, M.D.
Organization: McLean Hospital at time of study
Phone: 6179065063
EMail: jhalpern@recoverycoa.com
Layout table for additonal information
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