Trial Outcomes & Findings for MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer (NCT NCT00252174)
NCT ID: NCT00252174
Last Updated: 2017-11-14
Results Overview
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.
TERMINATED
PHASE2
2 participants
Obtained over the 3 months of active participation
2017-11-14
Participant Flow
Participant milestones
| Measure |
Stage 1, Active
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.
|
Stage 1, Control
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.
|
Stage 2, Active
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 Study
STARTED
|
0
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Stage 1, Active
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.
|
Stage 1, Control
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.
|
Stage 2, Active
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 Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer
Baseline characteristics by cohort
| Measure |
Stage 1, Active
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.
|
Stage 1, Control
n=2 Participants
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.
|
Stage 2, Active
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
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
—
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
—
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
—
|
66 years
n=7 Participants
|
—
|
66 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
—
|
2 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
standardized assessment of anxiety
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
paper pencil tests capturing data on spiritual well-being, overall functioning living with cancer, psychiatric mental status, and on spiritual self-perception.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
standardized questions to evaluate extent of depression and thoughts of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
daily log of anxiolytic medication usage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
daily measure of self-reported pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
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" \[e.g. severely depressed or anxious\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over the 3 months of active participationPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
Daily self-report measure for anxiety.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained over 3 months of studyPopulation: Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material
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.
Outcome measures
Outcome data not reported
Adverse Events
Stage 1, Active
Stage 1, Control
Stage 2, Active
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place