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The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy?
Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy.
This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA HCl (plus an optional supplemental dose of 62.5 mg MDMA HCl) with therapy and five participants were randomized to the placebo with therapy condition. The study consisted of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant was unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving MDMA were to complete a third open-label experimental session of MDMA-assisted therapy and participants who originally received placebo had the opportunity to cross over to open-label Stage 2 and receive active MDMA-assisted therapy in 3 sessions.
The primary objective of the study is to assess changes in trait anxiety in subjects receiving active dose MDMA compared to those receiving placebo as measured by State-Trait Anxiety Index (STAI) Trait scores from Baseline to the Primary Endpoint (one month after the second experimental session).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo with therapy | Placebo Comparator | Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose. |
|
| MDMA-assisted therapy (125 mg) | Experimental | 125 mg midomafetamine HCl administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midomafetamine HCl | Drug | Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint | The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Primary Endpoint STAI Trait Score | The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive. | One month post-2nd experimental session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in STAI State Score From Baseline to Primary Endpoint | The state subscale of the STAI (STAI-S) is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Like the trait subscale, participants respond to each item on the state subscale by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Wolfson, MD | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Offices of Philip Wolfson MD | San Anselmo | California | 94960 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33235285 | Result | Wolfson PE, Andries J, Feduccia AA, Jerome L, Wang JB, Williams E, Carlin SC, Sola E, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020 Nov 24;10(1):20442. doi: 10.1038/s41598-020-75706-1. |
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We will share outcome data appearing in any published reports upon request.
Data and study-related documents will be available when all participants have completed the study, and when data has been quality checked and locked.
Interested persons should correspond with the central contact for the multisite study.
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Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, and through word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo With Therapy | Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart. |
| FG001 | MDMA-assisted Therapy (125 mg) | 125 mg midomafetamine HCl administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) set
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo With Therapy | Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint | The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo With Therapy (Blinded) | Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Lykos Therapeutics | 877-627-7722 | trialdata@lykospbc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2015 | May 24, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2017 | May 25, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2016 | Jun 14, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Placebo | Drug | Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart. |
|
|
| Therapy | Behavioral | Manualized therapy |
|
| Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint | The Beck Depression Inventory-II (BDI-II) is a a 21-item self-reported measure of depression according to Diagnostic and Statistical Manual IV (DSM-IV) criteria. Each item is rated on a 4-point Likert scale ranging from 0 to 3. The total score is the sum of 21 items and range from 0 to 63. Score cutoffs indicate: 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression. Higher scores indicate more severe depressive symptoms. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint | The Global Assessment of Function (GAF) is a measure of a person's global social functioning made through clinical observation. The GAF consists of a single score, with scores ranging from 0 to 100, with 100 reflecting superior function and zero reflecting serious risk of causing harm to the self or others. | Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session) |
| Change in MADRS Score From Baseline to Primary Endpoint | The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item, clinician administered questionnaire used to diagnose the severity of depressive episodes. Each item has a score of 0 to 6. Overall scores are summed and range from 0 to 60. Score cutoffs indicate: 0-6 normal/symptom absent, 7-19 mild depression, 20-34 moderate depression, > 34 severe depression. Higher scores indicate greater severe depression. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint | The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality over a one month period. It consists of 19 items with possible responses ranging from zero to four on a five-point scale. The PSQI consists of seven sub-scales: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. These are all summed to produce a single global scale. Global scores can range from 0 to 21, with higher scores reflecting poorer sleep quality, and a score below 5 indicating good sleep quality. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint | The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales; relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Questions are answered on a scale from 0 (I did not experience this change) to 5 (I experienced this change to a great degree). Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint | The Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) is a 27-item self-report measure of quality of life issues specifically relevant to individuals with a chronic or life-threatening illness or condition. The core questionnaire consists of four subscales: Physical Well-being, Social/Family Well-being, Emotional Well-being, and Functional Well-being. Responses range from 0 (not at all) to 4 (very much), with higher scores indicating greater well-being. For each subscale, total scores were summed and range from 0 to 16. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint | The Death Attitudes Profile (DAP) is a 32-item self-reported questionnaire that assesses individual attitudes and beliefs about death and dying. Each item on the scale is rated along a 7-point Likert scale ranging from "strongly disagree" (score of 1) to "strongly agree" (score of 7), with higher scores indicating more positive attitudes toward death. The DAP consists of 5 dimensions: fear of death (7 items summed with total scores ranging from 7 to 49), death avoidance (5 items summed with total scores ranging from 5 to 35), neutral acceptance (5 items summed with total scores ranging from 5 to 35), approach acceptance (10 items summed with total scores ranging from 10 to 70), and escape acceptance (5 items summed with total scores ranging from 5 to 35). For each dimension, a mean scale score can be computed by dividing the total scale score by the number of items forming each scale. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint | The Self-Compassion Scale (SCS) is a 26-item self-reported questionnaire that assesses how respondents relate to themselves and treat themselves during difficult or painful experiences. Items are scored along a 5-point Likert-type scale ranging from 1 "almost never" to 5 "almost always." The SCS has six component (subscale) scores: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Subscale scores are calculated by computing the mean of subscale item responses. A total self-compassion score is calculated by the sum of the subscale scores and range from 24 to 120 with higher scores indicating greater self compassion. Higher scores have been found to correlate with positive mental health outcomes, as well as decreased depression and anxiety. | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
| MDMA-assisted Therapy (125 mg) |
125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline State-Trait Anxiety Inventory Trait (STAI-T) | The State-Trait Anxiety Inventory (STAI) Trait scale is a 20-item self-report measure of intensity of trait anxiety, defined as "long-standing nervous affect or anxiety disorder." Each item is rated on a 4-point scale ranging from 1 ('Not at all') to 4 ('Very Much So'). Items are summed for a total score ranging from 20 to 80, with higher scores indicating greater trait anxiety. | Mean | Standard Deviation | units on a scale |
|
Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart. |
| OG001 | MDMA-assisted Therapy (125 mg) | 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart. |
|
|
| Primary | Primary Endpoint STAI Trait Score | The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | One month post-2nd experimental session |
|
|
|
| Secondary | Change in STAI State Score From Baseline to Primary Endpoint | The state subscale of the STAI (STAI-S) is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Like the trait subscale, participants respond to each item on the state subscale by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint | The Beck Depression Inventory-II (BDI-II) is a a 21-item self-reported measure of depression according to Diagnostic and Statistical Manual IV (DSM-IV) criteria. Each item is rated on a 4-point Likert scale ranging from 0 to 3. The total score is the sum of 21 items and range from 0 to 63. Score cutoffs indicate: 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression. Higher scores indicate more severe depressive symptoms. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint | The Global Assessment of Function (GAF) is a measure of a person's global social functioning made through clinical observation. The GAF consists of a single score, with scores ranging from 0 to 100, with 100 reflecting superior function and zero reflecting serious risk of causing harm to the self or others. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session) |
|
|
|
| Secondary | Change in MADRS Score From Baseline to Primary Endpoint | The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item, clinician administered questionnaire used to diagnose the severity of depressive episodes. Each item has a score of 0 to 6. Overall scores are summed and range from 0 to 60. Score cutoffs indicate: 0-6 normal/symptom absent, 7-19 mild depression, 20-34 moderate depression, > 34 severe depression. Higher scores indicate greater severe depression. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint | The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality over a one month period. It consists of 19 items with possible responses ranging from zero to four on a five-point scale. The PSQI consists of seven sub-scales: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. These are all summed to produce a single global scale. Global scores can range from 0 to 21, with higher scores reflecting poorer sleep quality, and a score below 5 indicating good sleep quality. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint | The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales; relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Questions are answered on a scale from 0 (I did not experience this change) to 5 (I experienced this change to a great degree). Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint | The Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) is a 27-item self-report measure of quality of life issues specifically relevant to individuals with a chronic or life-threatening illness or condition. The core questionnaire consists of four subscales: Physical Well-being, Social/Family Well-being, Emotional Well-being, and Functional Well-being. Responses range from 0 (not at all) to 4 (very much), with higher scores indicating greater well-being. For each subscale, total scores were summed and range from 0 to 16. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint | The Death Attitudes Profile (DAP) is a 32-item self-reported questionnaire that assesses individual attitudes and beliefs about death and dying. Each item on the scale is rated along a 7-point Likert scale ranging from "strongly disagree" (score of 1) to "strongly agree" (score of 7), with higher scores indicating more positive attitudes toward death. The DAP consists of 5 dimensions: fear of death (7 items summed with total scores ranging from 7 to 49), death avoidance (5 items summed with total scores ranging from 5 to 35), neutral acceptance (5 items summed with total scores ranging from 5 to 35), approach acceptance (10 items summed with total scores ranging from 10 to 70), and escape acceptance (5 items summed with total scores ranging from 5 to 35). For each dimension, a mean scale score can be computed by dividing the total scale score by the number of items forming each scale. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| Secondary | Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint | The Self-Compassion Scale (SCS) is a 26-item self-reported questionnaire that assesses how respondents relate to themselves and treat themselves during difficult or painful experiences. Items are scored along a 5-point Likert-type scale ranging from 1 "almost never" to 5 "almost always." The SCS has six component (subscale) scores: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Subscale scores are calculated by computing the mean of subscale item responses. A total self-compassion score is calculated by the sum of the subscale scores and range from 24 to 120 with higher scores indicating greater self compassion. Higher scores have been found to correlate with positive mental health outcomes, as well as decreased depression and anxiety. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | MDMA-assisted Therapy (125 mg) (Blinded) | 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart. | 0 | 13 | 0 | 13 | 11 | 13 |
| EG002 | Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg) | Unblinded Crossover 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 3 open-label experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG003 | MDMA Group Open-label MDMA-assisted Therapy (125 mg) | Open-Label 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered during open-label 1 experimental session. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. | 0 | 13 | 0 | 13 | 3 | 13 |
| EG004 | Placebo With Therapy Group 12-month Follow-up | Follow-up with placebo with therapy group 12 months after end of Stage 2. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG005 | MDMA-assisted Therapy Group 12-month Follow-up | Follow-up with MDMA-assisted therapy group 12 months after end of Stage 1. | 1 | 13 | 3 | 13 | 3 | 13 |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Spinal cord paralysis | Nervous system disorders | Systematic Assessment |
|
| Chordoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Meningitis | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Balance Disorder | Nervous system disorders | Systematic Assessment |
|
| Bruxism | Psychiatric disorders | Systematic Assessment |
|
| Clumsiness | Nervous system disorders | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypomania | Psychiatric disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | Systematic Assessment |
|
| Skin Abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tinea Infection | Infections and infestations | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Weight Decreased | Investigations | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heart rate irregular | Investigations | Systematic Assessment |
|
| Muscle contractions | Nervous system disorders | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Oral herpes | Infections and infestations | Systematic Assessment |
|
| Hot flush | Vascular disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | Systematic Assessment |
|
| Sciatica | Nervous system disorders | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Scleroderma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aphasia | Nervous system disorders | Systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| Organic Chemicals |
| Emotional well-being |
|
| Functional well-being |
|
| Additional concerns |
|
| Neutral acceptance |
|
| Approach acceptance |
|
| Escape acceptance |
|