Status:

COMPLETED

Stanford Regulating Circuits of the Brain Study- Ketamine

Lead Sponsor:

Stanford University

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Healthy

Eligibility:

All Genders

18-55 years

Brief Summary

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

Detailed Description

The investigators will assess the effect of acute ketamine modulation on the functioning of reward-related human brain circuits. Reward-related brain circuits will be assessed using functional magneti...

Eligibility Criteria

Inclusion

  • Ages 18-55 years
  • At least 2 prior uses of ketamine when aged 18+
  • BMI within healthy range (18-30)
  • Ability to speak, read, or understand English

Exclusion

  • Current active suicide ideation or history of suicide attempts
  • Current mood, anxiety, eating, psychotic, or substance use disorder
  • Lifetime psychotic or bipolar disorder
  • Schizophrenia in a first degree relative
  • Current use of psychotropic medication
  • Prior adverse ketamine response
  • Allergy or hypersensitivity to ketamine
  • Use of ketamine in past 7 days
  • Cannabis use in the past 7 days, illicit recreational drug use in the 48 hours prior to sessions, and/or alcohol use in the 24 hours prior to sessions
  • Concurrent use of any medications that might increase the risk of participation (e.g., drug interactions)
  • History of epilepsy, convulsions, seizures, LOC \>10 min
  • Renal/hepatic impairment
  • Hypertension (Stage 1 defined as systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg on 2 of 3 measurements at least 15 min apart at initial screening; systolic blood pressure \>155 mmHg or diastolic blood pressure \>99 mmHg on 2 of 3 measurements at least 15 min apart during infusion visits)
  • Heart rate \<50 bpm or \>150 bpm at initial screening
  • Chronic congestive heart failure, tachyarrhythmias, myocardial ischemia assessed via EKG at initial screening
  • EKG QTcF intervals \>430 ms for men and \>470 ms for women
  • Direct physical access to or routine handling of addicting drugs in the regular course of work duties
  • MRI contraindication
  • Pregnant or nursing females

Key Trial Info

Start Date :

August 19 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2024

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT03475277

Start Date

August 19 2019

End Date

July 1 2024

Last Update

January 2 2026

Active Locations (1)

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Stanford Psychiatry

Palo Alto, California, United States, 94304