Trial Outcomes & Findings for Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial (NCT NCT01458327)

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

3 participants

Primary outcome timeframe

Less than 4 weeks before first experimental session

Results posted on

2024-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later MDMA-AT: MDMA-assisted therapy
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 Participants 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later MDMA-AT: MDMA-assisted therapy
Age, Continuous	46.9 years STANDARD_DEVIATION 7.79 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Less than 4 weeks before first experimental session

Population: Intent-to-treat

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

Outcome measures
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 Participants 125 mg and 62.5 mg MDMA and therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later Therapy: MDMA-assisted therapy
Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)	93.3 score on a scale Standard Deviation 1.53

PRIMARY outcome

Timeframe: 2 months post experimental session

Population: Intent-to-treat

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

Outcome measures
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 Participants 125 mg and 62.5 mg MDMA and therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later Therapy: MDMA-assisted therapy
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up	31.3 score on a scale Standard Deviation 12.01

PRIMARY outcome

Timeframe: 12 months post experimental session

Population: Intent-to-treat

The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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

Outcome measures
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 Participants 125 mg and 62.5 mg MDMA and therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later Therapy: MDMA-assisted therapy
Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up	52.7 score on a scale Standard Deviation 39.63

PRIMARY outcome

Timeframe: Baseline to 2 months post experimental session

Population: Intent-to-treat

The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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

Outcome measures
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 Participants 125 mg and 62.5 mg MDMA and therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later Therapy: MDMA-assisted therapy
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up	-62.0 score on a scale Standard Deviation 12.53

PRIMARY outcome

Timeframe: Baseline to 12 months post experimental session

Population: Intent-to-treat

The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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

Outcome measures
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 Participants 125 mg and 62.5 mg MDMA and therapy 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later Therapy: MDMA-assisted therapy
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up	-40.7 score on a scale Standard Deviation 40.27

Adverse Events

3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 participants at risk 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later MDMA-AT: MDMA-assisted therapy
Psychiatric disorders Suicidal ideation	33.3% 1/3 • Number of events 1 • Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.

Other adverse events

Other adverse events
Measure	3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy n=3 participants at risk 3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later MDMA-AT: MDMA-assisted therapy
Psychiatric disorders Major depression	33.3% 1/3 • Number of events 1 • Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.
Psychiatric disorders Drug abuse	33.3% 1/3 • Number of events 1 • Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.
Psychiatric disorders Dissociation	33.3% 1/3 • Number of events 1 • Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1 • Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.

Additional Information

Berra Yazar-Klosinski, PhD / Chief Scientific Officer

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