Trial Search Results

Stanford Reward Circuits of the Brain Study - MDMA

This study is a biomarker study designed to characterize how MDMA impacts the reward circuits of the human brain.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institute on Drug Abuse (NIDA)

Stanford Investigator(s):

Intervention(s):

  • Drug: MDMA

Eligibility


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

Ages Eligible for Study

18 Years - 55 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leanne M Williams, PhD
6507233579
Not Recruiting