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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50DA042012-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Resilient Pharmaceuticals | INDUSTRY |
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This study is a biomarker study designed to characterize how human neural circuits and behaviors are modified during altered states induced by MDMA.
The investigators will assess the effect of acute MDMA modulation on the functioning of human brain circuits. Brain circuits will be assessed using functional magnetic resonance imaging.
Participants will include volunteers who report more than two prior uses of MDMA (also known as Ecstasy), when they were 18 years or older.
The investigators will recruit individuals who have previously tried MDMA rather than those who are MDMA-naïve.
Participants will receive an oral dose of MDMA (80mg and 120mg) and placebo (saline) at 3 separate study sessions. Following established procedures, these three sessions will be randomized in a blinded protocol in order to limit expectancy effects.
Throughout each session, participants will be monitored. Functional imaging will commence after the drug has reached peak levels, following previously established time courses for MDMA administered orally. Participants will also be monitored after the functional imaging session. Secondary effects of MDMA on behavior and self-reported experience will be assessed.
In the assessment of the acute effects of MDMA, the investigators will take into account the cumulative effects of prior drug exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA Within Subject Cross-over | Participants will be randomized to high-dose, low-dose, or placebo for each of the the three study sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA | Drug | 80mg, 120mg, Placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Facial Expressions of Emotion Task (FEET, nonconscious and conscious) evoked functional activity and connectivity | For the non-conscious task, participants are shown a series of faces, presented in pairs. The first face in each pair is presented for only a fraction of a second and may be hard to see. Participants press a button every time they see a face. For the conscious task, participants do the same thing same but with a new set of faces. | up to 2 hours after the administration of MDMA or Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state functional activity and connectivity | Participants will be instructed to stare at a white cross on a black background. During this time, their eyes will be monitored using an eye-tracker by the study coordinator to ensure that the participant is not asleep. Four separate 5-min runs of resting state data will be acquired, two with a posterior-anterior phase encoding direction and the other two with a posterior-anterior direction. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy participants ages 18-55 years who have had at least two prior exposures to MDMA
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Williams, PhD | Stanford PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Psychiatry and Behavioral Sciences Department | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40305021 | Result | Zhang X, Hack LM, Bertrand C, Hilton R, Gray NJ, Boyar L, Laudie J, Heifets BD, Suppes T, van Roessel PJ, Rodriguez CI, Deisseroth K, Knutson B, Williams LM. Negative Affect Circuit Subtypes and Neural, Behavioral, and Affective Responses to MDMA: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257803. doi: 10.1001/jamanetworkopen.2025.7803. |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| up to 2 hours after the administration of MDMA or Placebo |
| MID evoked functional activity and connectivity | Participants watch the screen and see a cue in the form of a circle or square, either of which can be empty or dashed, wait a delay of a varied amount of time, and then seen the target (a white triangle), which they are instructed to respond to with a button press as quickly as possible. The participant is instructed to attempt to press a button while the target is on the screen to either win money or avoid losing money. A feedback slide is presented after each trial to inform the participant whether they were successful on that trial, and the resulting gain or loss of money. | up to 2 hours after the administration of MDMA or Placebo |
| Go-No-Go evoked functional activity and connectivity | 'Go' trials (the word "press" in GREEN) require participants to respond as quickly as possible, while the 'NoGo' trials ("press" in RED) require participants to withhold responses. | up to 2 hours after the administration of MDMA or Placebo |
| Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity | Accuracy data are quantified as number of errors and lower values indicate better performance. The results across all the individual tests are aggregated to a single report that details function as compared to a normative database. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 21-item Depression, Anxiety and Stress Scale (DASS) | Responses are quantified on a 4-point scale and summed for total DASS score and for each Depression, Anxiety and Subscale score. Higher scores indicate more severe symptoms of depression, anxiety and stress. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 29-item Rotter's Locus of Control (RLoC) | Responses are quantified as a summed score from 0 to 23 and determine the degree to which a person perceives an outcome as being contingent on their own actions or those of external forces. Higher scores indicate greater levels of external locus of control. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 15-item Mini Brief Risk-Resilience Index for Screening (BRISC) | Responses are quantified on a 5-point Likert scale and is a measure of emotional self-regulation. Scores measure three core domains: negativity bias, emotional resilience, and social skills. Higher scores indicate higher functioning and better coping. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 14-item Snaith-Hamilton Please Scale (SHAPS) | Responses are quantified on a 4-point scale and measures anhedonia, the inability to experience pleasure. Scores measure domains of social interaction, food and drink, sensory experience, and interest/pastimes. An "abnormal" score is defined as 3 or more. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 24-item Dimensional Apathy Scale (DAS) | Responses are quantified on a 4-point scale and measure demotivation in three domains: executive apathy, emotional apathy, and initiation apathy. Higher scores indicate higher apathy level. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 18-item Motivation and Pleasure Scale Self-Report (MAP-SR) | Responses are quantified on a 5-point Likert scale and assesses an individual's motivation and pleasure. Total scores range from 0-72 and higher scores indicate greater motivation and pleasure during everyday activities. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 17-item Dimensional Anhedonia Rating Scale (DARS) | Responses are summed on a 5-point scale. Scores assess interest, motivation, effort, and consummatory pleasure across four domains: hobbies, food/drink, social activities, and sensory experiences. Lower scores represent a higher level of anhedonia. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 94-item 5-Dimensional Altered States of Consciousness Rating Scale (DASC) | Responses are recorded on a sliding scale with one side reading 'No, not more than usually' and the opposite reading 'Yes, much more than usually'. More agreeance to the statements represents that the individual is experiencing higher levels of altered states of consciousness. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 23-item Social Reward Questionnaire (SRQ) | Responses are averaged on a 7-point Likert scale in relation to the six subscales. Scores assess individual difference in the value of different social rewards. The six subscales of social reward that the questionnaire measures are admiration, negative social potency, passivity, prosocial interactions, sexual reward, and sociability. | up to 5 hours after the administration of MDMA or Placebo |
| Self-administered computerized task assessed by Multifaceted Empathy Test (MET) | Responses are recorded on a computer-based program. This task utilizes photographic stimuli for measuring both cognitive and emotional empathy. | up to 5 hours after the administration of MDMA or Placebo |
| Level of subjectively experienced mood and feelings as assessed by rating scale | Responses will be quantified by intervals of 10 on a scale of 1 to 100. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the 23-item Clinician Administered Dissociative States Scale (CADSS) | Responses are summed on a 5-point scale in rating one's agreeance to the dissociative statements as 'not at all' to 'extreme'. Scores assess individual's dissociative state. A higher score represents more dissociation. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by a clinician on the 18-item Brief Psychiatric Rating Scale (BPRS) | Responses are summed on a 7-point scale in rating one's severity to the statements as 'not assessed' to 'extremely severe'. Scores assess psychiatric symptoms like anxiety, depression, and psychoses. A higher score means the individual is presenting more extreme symptoms. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ) | Participants rate acceptance-related experiences and avoidance-related experiences using a visual analog scale from 0-100, with 0 indicating "No, not at all" and 100 indicating "Yes, extremely or absolutely". | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the MID Cue Rating | Survey created for the study where participants are asked to rate the stimulus presented during the MID task on a scale from -5 to 5, with -5 indicating that they disliked it very much, 0 indicating a neutral rating, and 5 indicating that they liked it very much. | up to 5 hours after the administration of MDMA or Placebo |
| Self-reported responses as assessed by the Face Likability Rating | Survey created for the study where participants are asked to rate the faces presented during the FEET task on a scale from 0 to 100, where 0 represents the most negative reaction, 50 represents a neutral reaction, and 100 represents the most positive reaction to the face. | up to 5 hours after the administration of MDMA or Placebo |
| Steroid hormone assay via saliva collection | At 6 different time points throughout drug administration visits the participant chews on a cotton swab for 30 seconds to collect saliva. A steroid hormone assay is conducted to collect data on cortisol, testosterone, progesterone, and estradiol levels. | up to 5 hours after the administration of MDMA or Placebo |
| Qualitative free responses | Subjects will be prompted to report their drug experience throughout the drug visit. | up to 5 hours after the administration of MDMA or Placebo |
| Organic Chemicals |