Stanford Regulating Circuits of the Brain Study- Ketamine

NCT03475277 | Completed DMC FDA Drug

• 2 other identifiers: 411731P50DA042012-01A1
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Circuit activation as assessed by functional magnetic resonance imaging

  During functional magnetic resonance imaging the reward and negative affect circuits 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

  Up to 2 weeks after infusion of ketamine or placebo

Secondary Outcomes (13)

• Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity

  Up to 5 hours after infusion of ketamine or placebo

• Self-reported responses as assessed by the 21-item Depression, Anxiety and Stress Scale (DASS)

  Up to 5 hours after infusion of ketamine or placebo

• Level of subjectively experienced intoxication, dissociation, and mood and feelings as assessed by rating scale.

  Up to 5 hours after infusion of ketamine or placebo

• Self-reported responses as assessed by the 29-item Rotter's Locus of Control (RLoC)

  Up to 5 hours after infusion of ketamine or placebo

• Self-reported responses as assessed by the 15-item Mini Brief Risk-Resilience Index for Screening (BRISC).

  Up to 5 hours after infusion of ketamine or placebo

Study Arms (1)

Volunteers

Participants will receive an IV infusion of ketamine (\~.05mg/kg and 0.5mg/kg) or placebo. Ketamine is an FDA-approved dissociative anesthetic. The study doses are in the subanesthetic range. During the infusion, an ACLS-certified psychiatrist or anesthesiologist will provide continuous monitoring. Afterwards, patients will be monitored on-site by an ACLS-certified MD or highly skilled research nursing staff, and an on-call emergency response team for 4 hours (ketamine's half-life is 15 min; 4 hrs= 16 half-lives).

Drug: Ketamine

Interventions

Ketamine DRUG

Acute administration

Also known as: "special k"

Volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers with prior exposure to ketamine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford Psychiatry

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Hack LM, Zhang X, Heifets BD, Suppes T, van Roessel PJ, Yesavage JA, Gray NJ, Hilton R, Bertrand C, Rodriguez CI, Deisseroth K, Knutson B, Williams LM. Ketamine's acute effects on negative brain states are mediated through distinct altered states of consciousness in humans. Nat Commun. 2023 Oct 19;14(1):6631. doi: 10.1038/s41467-023-42141-5.

  PMID: 37857620 RESULT

Related Links

• Link to results reference

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Leanne M Williams, PhD

  Study PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 23, 2018
• Study Start: August 19, 2019
• Primary Completion: November 30, 2022
• Study Completion: July 1, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)