MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer
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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
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Study Type | Interventional |
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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 |
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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
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Arm/Group Title | Stage 1, Active | Stage 1, Control | Stage 2, Active | Total | |
---|---|---|---|---|---|
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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 | |
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[Not Specified]
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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)
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66
(65 to 67)
|
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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%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
|||||
United States | Number Analyzed | 0 participants | 2 participants | 0 participants | 2 participants |
2 | 2 |
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 |