Trial Outcomes & Findings for MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD (NCT NCT02876172)
NCT ID: NCT02876172
Last Updated: 2025-06-04
Results Overview
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Primary Endpoint (Visit 16, approximately 2 months later)
Results posted on
2025-06-04
Participant Flow
Participant milestones
| Measure |
Patient MDMA and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
Partner MDMA and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partner does not have PTSD therefore CAPS-5 was not assessed per protocol
Baseline characteristics by cohort
| Measure |
Patient MDMA and CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
Partner MDMA and CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 12.54 • n=6 Participants
|
46.5 years
STANDARD_DEVIATION 11.17 • n=6 Participants
|
46.8 years
STANDARD_DEVIATION 11.33 • n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Baseline Global CAPS-5 Total Severity Score
|
42.0 units on a scale
STANDARD_DEVIATION 5.76 • n=6 Participants • Partner does not have PTSD therefore CAPS-5 was not assessed per protocol
|
—
|
42.0 units on a scale
STANDARD_DEVIATION 5.76 • n=6 Participants • Partner does not have PTSD therefore CAPS-5 was not assessed per protocol
|
PRIMARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
|
16.3 score on a scale
Standard Deviation 13.71
|
PRIMARY outcome
Timeframe: Baseline to Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD Patient
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score
|
-25.7 score on a scale
Standard Deviation 13.89
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Pittsburgh Sleep Quality Index (PSQI)
|
14.24 score on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)
|
10.37 score on a scale
Standard Deviation 4.49
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Patient Beck Depression Inventory-II (BDI-II)
|
32.91 score on a scale
Standard Deviation 8.75
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)
|
12.75 score on a scale
Standard Deviation 16.88
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Patient Couples Satisfaction Index (CSI)
|
105.37 score on a scale
Standard Deviation 13.39
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Patient Couples Satisfaction Index (CSI)
|
127.00 score on a scale
Standard Deviation 34.34
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient's partner
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Partner Couples Satisfaction Index (CSI)
|
98.1 score on a scale
Standard Deviation 50.81
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient's partner
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Partner Couples Satisfaction Index (CSI)
|
125.34 score on a scale
Standard Deviation 30.59
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = "Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Trauma and Attachment Beliefs Scale (TABS)
|
289.78 score on a scale
Standard Deviation 44.30
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = "Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)
|
232.7 score on a scale
Standard Deviation 69.07
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
|
21.77 score on a scale
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
|
28.34 score on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale
|
18.96 score on a scale
Standard Deviation 6.28
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale
|
13.63 score on a scale
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Patient PTSD Checklist-5 (PCL-5)
|
62.64 score on a scale
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Patient PTSD Checklist-5 (PCL-5)
|
23.96 score on a scale
Standard Deviation 19.08
|
SECONDARY outcome
Timeframe: Baseline (screening)Population: PTSD patient's partner
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Baseline Partner-rated PTSD Checklist-5 (PCL-5)
|
49.58 score on a scale
Standard Deviation 8.52
|
SECONDARY outcome
Timeframe: Primary Endpoint (Visit 16, approximately 2 months later)Population: PTSD patient's partner
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Outcome measures
| Measure |
MDMA (75 mg or 100 mg) + CBCT
n=6 Participants
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|
|
Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5)
|
21.54 score on a scale
Standard Deviation 19.67
|
Adverse Events
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PTSD Patients at 6-month Follow-up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CSO Patients at 6-month Follow-up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
n=6 participants at risk
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
n=6 participants at risk
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
PTSD Patients at 6-month Follow-up
n=6 participants at risk
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
CSO Patients at 6-month Follow-up
n=6 participants at risk
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Eye disorders
Visual Impairment
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
General disorders
Asthenia
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
General disorders
Fatigue
|
33.3%
2/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Nervous system disorders
Disturbance in attention
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion, spontaneous
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Psychiatric disorders
Tic
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Infections and infestations
Urethritis
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
16.7%
1/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
0.00%
0/6 • Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place