Stanford Reward Circuits of the Brain Study - MDMA (RBRAIN-MDMA)
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|ClinicalTrials.gov Identifier: NCT04060108|
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment|
The investigators will assess the effect of acute MDMA modulation on the functioning of reward-related human brain circuits. Reward-related 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 (~.75mg/kg and 1.5mg/kg) 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Mapping the Influence of Drugs of Abuse on Risk and Reward Circuits - MDMA|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
MDMA Within Subject Cross-over
Participants will be randomized to high-dose, low-dose, or placebo for each of the the three study sessions.
.75mg/kg, 1.5 mg/kg, Placebo
Other Name: 3,4-Methyl enedioxy methamphetamine, ecstasy
- Reward circuit activation as assessed by functional magnetic resonance imaging [ Time Frame: up to 2 weeks after adminstration of MDMA or placebo ]During functional magnetic resonance imaging the reward circuit will be engaged by reward and related emotional tasks, and circuit activation will be quantified by blood flow in regions of interest and the extent of functional connectivity between them
- Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity [ Time Frame: up to 5 hours after the adminstration of MDMA or Placebo ]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 singe report that details function as compared to a normative database.
- Self-reported responses as assessed by the 21-item Depression, Anxiety and Stress Scale (DASS) [ Time Frame: up to 5 hours after the adminstration of MDMA or Placebo ]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
- Self-reported responses as assessed by the Profile of Mood States (POMS) [ Time Frame: up to 5 hours after the adminstration of MDMA or Placebo ]Responses are quantified as summed scores for negative and positive mood states. Scores range from 1 (not at all) to 5 (extremely) and measures six different dimensions of mood swings over a period of time including: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment.
- Level of subjectively experienced intoxication as assessed by a visual analogue intoxication scale [ Time Frame: up to 5 hours after the adminstration of MDMA or Placebo ]Responses will be quantified in intervals of 10 on a visual analogue scale of 1 to 100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060108
|Contact: Lauren M Whicker||(650) firstname.lastname@example.org|
|Contact: Jake Hartley||(650) email@example.com|
|Principal Investigator:||Leanne M Williams, PhD||Stanford PI|