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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 12, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Leanne Williams, Stanford University

Tracking Information
First Submitted Date August 6, 2019
First Posted Date August 16, 2019
Last Update Posted Date March 12, 2021
Estimated Study Start Date May 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 10, 2019)
  • 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
Original Secondary Outcome Measures
 (submitted: August 15, 2019)
  • 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
  • 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 Intertia, 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 of 1 to 100
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stanford Reward Circuits of the Brain Study - MDMA
Official Title Mapping the Influence of Drugs of Abuse on Risk and Reward Circuits - MDMA
Brief Summary This study is a biomarker study designed to characterize how MDMA impacts the reward circuits of the human brain.
Detailed Description

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
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy participants ages 18-55 years who have had at least two prior exposures to MDMA
Condition Healthy
Intervention Drug: MDMA
.75mg/kg, 1.5 mg/kg, Placebo
Other Name: 3,4-Methyl enedioxy methamphetamine, ecstasy
Study Groups/Cohorts MDMA Within Subject Cross-over
Participants will be randomized to high-dose, low-dose, or placebo for each of the the three study sessions.
Intervention: Drug: MDMA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 15, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. ages 18-55
  2. either gender and all ethno-racial categories
  3. able and willing to enroll and provide written informed consent
  4. able to comply with study procedures
  5. able to receive an MRI
  6. 2 or more prior uses of MDMA when aged 18 years or older (for MDMA arm)

Exclusion Criteria:

  1. Current active suicide ideation or history or suicide attempts
  2. Lifetime psychotic or bipolar disorder.
  3. BMI outside of healthy range (18-30)
  4. Inability to speak, read or understand English
  5. Plan to move out of the area during the study period (given repeated testing sessions)
  6. Pregnant or nursing females
  7. MRI contraindication
  8. Cannabis use in the past 7 days, alcohol use in the past 24 hours and/or other illicit recreational drug use in the 48 hours prior to sessions. In addition to self-report, these exclusion criteria will be assessed by a urine screen, saliva sample, or breathalyzer.
  9. Investigator discretion for clinical safety or protocol adherence (e.g., presence of metallic device or dental braces, which are contraindications for MRI).
  10. Use of MDMA in the past 7 days.
  11. Direct physical access to or routinely handling of addicting drugs in the regular course of work duties.
  12. Allergy or hypersensitivity to MDMA
  13. Current mood, anxiety, eating or psychotic disorder
  14. Current use of Psychotropic Medication
  15. Schizophrenia in a first degree relative.
  16. Concurrent use of any medication that might increase the risk of participation.
  17. Renal/hepatic impairment (assessed via laboratory tests during initial screening appointment)
  18. Hypertension (Hypertension, Stage 1 as defined by a systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg on two of three measurements at least 15 minutes apart at initial screening appointment; systolic blood pressure >155 mmHg or diastolic blood pressure >99 mmHg on two of three measurements at least 15 minutes apart during drug administration visits)
  19. Heart rate <50bpm or >150bpm assessed at initial screening visit (PI discretion for bradycardia)
  20. Chronic congestive heart failure, tachyarrhythmias, myocardial ischemia (assessed via EKG at initial screening appointment)
  21. EKG QTcF intervals >430msec for men and >470msec for women
  22. History of epilepsy, convulsions, seizures, loss of consciousness > 10 min assessed at screening
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lauren M Whicker (650) 497-6480 laurenwhicker@stanford.edu
Contact: John Coman (650) 497-6481 coman@stanford.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04060108
Other Study ID Numbers 52244
1P50DA042012-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Leanne Williams, Stanford University
Study Sponsor Stanford University
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Leanne M Williams, PhD Stanford PI
PRS Account Stanford University
Verification Date March 2021