Trial Outcomes & Findings for Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder (NCT NCT00353938)
NCT ID: NCT00353938
Last Updated: 2024-07-15
Results Overview
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)
Results posted on
2024-07-15
Participant Flow
Participants were recruited by calling for referrals from psychiatric hospitals, trauma counseling centers, psychiatrists and psychotherapists in the German-speaking part of Switzerland.
Only active control participants from Stage 1 entered into open-label Stage 2 and only participants who received full dose in Stage1 or Stage 2 and did not respond with significant improvement were offered the opportunity to partake in open-label Stage 3.
Participant milestones
| Measure |
Full Dose MDMA-assisted Therapy (125 mg Stage 1)
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Active Placebo MDMA-assisted Therapy (25 mg Stage 1)
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Full Dose MDMA-assisted Therapy (125 mg Stage 2)
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
|
Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later.
3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
0
|
0
|
|
Overall Study
Completed Stage 2
|
0
|
0
|
4
|
0
|
|
Overall Study
Completed Stage 3
|
0
|
0
|
0
|
3
|
|
Overall Study
COMPLETED
|
8
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Full Dose MDMA-assisted Therapy (125 mg)
n=8 Participants
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Active Placebo MDMA-assisted Therapy (25 mg)
n=4 Participants
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 12.8 • n=8 Participants
|
40.0 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
41.4 years
STANDARD_DEVIATION 11.2 • n=12 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=8 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=8 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Country of origin
Switzerland
|
7 Participants
n=8 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=12 Participants
|
|
Country of origin
France
|
1 Participants
n=8 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=12 Participants
|
|
Work status
On disability
|
4 Participants
n=8 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=12 Participants
|
|
Work status
Fit for limited employment
|
2 Participants
n=8 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=12 Participants
|
|
Work status
Working full-time
|
1 Participants
n=8 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=12 Participants
|
|
Work status
Retired
|
1 Participants
n=8 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=12 Participants
|
|
Duration of PTSD
|
16.4 years
STANDARD_DEVIATION 10.9 • n=8 Participants
|
22.3 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
18.3 years
STANDARD_DEVIATION 12.0 • n=12 Participants
|
|
Duration of prior therapy
|
39.9 months
STANDARD_DEVIATION 73.3 • n=8 Participants
|
123 months
STANDARD_DEVIATION 60.6 • n=4 Participants
|
85.8 months
STANDARD_DEVIATION 71.4 • n=12 Participants
|
|
On medication for PTSD at enrollment
Yes
|
4 Participants
n=8 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=12 Participants
|
|
On medication for PTSD at enrollment
No
|
4 Participants
n=8 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
Full Dose MDMA-assisted Therapy (125 mg)
n=8 Participants
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Active Placebo MDMA-assisted Therapy (25 mg)
n=4 Participants
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
|---|---|---|
|
Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
|
-15.6 score on a scale
Standard Deviation 18.1
|
3.3 score on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.
Outcome measures
| Measure |
Full Dose MDMA-assisted Therapy (125 mg)
n=8 Participants
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Active Placebo MDMA-assisted Therapy (25 mg)
n=4 Participants
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
|---|---|---|
|
Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)
|
-8.6 score on a scale
Standard Deviation 13.0
|
7.3 score on a scale
Standard Deviation 6.2
|
Adverse Events
Full Dose MDMA-assisted Therapy (125 mg Stage 1)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Active Placebo MDMA-assisted Therapy (25 mg Stage 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Full Dose MDMA-assisted Therapy (125 mg Stage 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Full Dose MDMA-assisted Therapy (125 mg Stage 1)
n=9 participants at risk
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Active Placebo MDMA-assisted Therapy (25 mg Stage 1)
n=5 participants at risk
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Full Dose MDMA-assisted Therapy (125 mg Stage 2)
n=4 participants at risk
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
|
Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
n=3 participants at risk
Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later.
3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metasteses to central nervous system
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Suicidal behavior
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
Other adverse events
| Measure |
Full Dose MDMA-assisted Therapy (125 mg Stage 1)
n=9 participants at risk
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Active Placebo MDMA-assisted Therapy (25 mg Stage 1)
n=5 participants at risk
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
Therapy: Non-directive therapy performed by a team of two co-therapists
|
Full Dose MDMA-assisted Therapy (125 mg Stage 2)
n=4 participants at risk
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
|
Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
n=3 participants at risk
Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later.
3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
|
|---|---|---|---|---|
|
Psychiatric disorders
Panic attack
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Investigations
Red blood cell sedimentation rate increased
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Anxiety
|
44.4%
4/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Depressed mood
|
22.2%
2/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Disturbance in attention
|
22.2%
2/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
General disorders
Fatigue
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
40.0%
2/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
33.3%
1/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Limb injury
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia chlamydial
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Somatoform disorder
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Somnolence
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Tension
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Nervous system disorders
Visual acuity reduced
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Metabolism and nutrition disorders
Iron deficiency Anemia
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
25.0%
1/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
General disorders
Pain
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
20.0%
1/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
1/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/3 • From baseline to end of Stage 3 (approximately 1 year)
|
|
Infections and infestations
Angina tonsillitus
|
0.00%
0/9 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/5 • From baseline to end of Stage 3 (approximately 1 year)
|
0.00%
0/4 • From baseline to end of Stage 3 (approximately 1 year)
|
33.3%
1/3 • From baseline to end of Stage 3 (approximately 1 year)
|
Additional Information
Julie B. Wang, MPH, PhD/ Senior Clinical Data Scientist
Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.
Phone: (831) 429-6362
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place