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Stanford Regulating Circuits of the Brain Study- Ketamine (RBRAIN-KET)

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ClinicalTrials.gov Identifier: NCT03475277
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Leanne Williams, Stanford University

Tracking Information
First Submitted Date March 1, 2018
First Posted Date March 23, 2018
Last Update Posted Date April 14, 2022
Actual Study Start Date July 30, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2018)
Reward circuit activation as assessed by functional magnetic resonance imaging [ Time Frame: Up to 2 weeks after infusion of ketamine 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: January 7, 2022)
  • Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity [ Time Frame: Up to 5 hours after infusion of ketamine 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 infusion of ketamine 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
  • Level of subjectively experienced intoxication, dissociation, and mood and feelings as assessed by rating scale. [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses will be quantified in intervals of 10 on a visual analogue of 1 to 100
  • Self-reported responses as assessed by the 29-item Rotter's Locus of Control (RLoC) [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are quantified as a summed score from 0 to 23 and determine the degree to which a person perceives an outcome as being contingent on their own actions or those of external forces. Higher scores indicate greater levels of external locus of control.
  • Self-reported responses as assessed by the 15-item Mini Brief Risk-Resilience Index for Screening (BRISC). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are quantified on a 5-point Likert scale and is a measure of emotional self-regulation. Scores measure three core domains: negativity bias, emotional resilience, and social skills. Higher scores indicate higher functioning and better coping.
  • Self-reported responses as assessed by the 14-item Snaith-Hamilton Please Scale (SHAPS). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are quantified on a 4-point scale and measures anhedonia, the inability to experience pleasure. Scores measure domains of social interaction, food and drink, sensory experience, and interest/pastimes. An "abnormal" score is defined as 3 or more.
  • Self-reported responses as assessed by the 24-item Dimensional Apathy Scale (DAS). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are quantified on a 4-point scale and measure demotivation in three domains: executive apathy, emotional apathy, and initiation apathy. Higher scores indicate higher apathy level.
  • Self-reported responses as assessed by the 18-item Motivation and Pleasure Scale Self-Report (MAP-SR). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are quantified on a 5-point Likert scale and assesses an individual's motivation and pleasure. Higher scores indicate higher levels of motivation and pleasure.
  • Self-reported responses as assessed by the 17-item Dimensional Anhedonia Rating Scale (DARS). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are summed on a 5-point scale. Scores assess interest, motivation, effort, and consummatory pleasure across four domains: hobbies, food/drink, social activities, and sensory experiences. Lower scores represent a higher level of anhedonia.
  • Self-reported responses as assessed by the 94-item 5-Dimensional Altered States of Consciousness Rating Scale (DASC). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are recorded on a sliding scale with one side reading 'No, not more than usually' and the opposite reading 'Yes, much more than usually'. More agreeance to the statements represents that the individual is experiencing higher levels of altered states of consciousness.
  • Self-reported responses as assessed by the 23-item Clinician Administered Dissociative States Scale (CADSS). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are summed on a 5-point scale in rating one's agreeance to the dissociative statements as 'not at all' to 'extreme'. Scores assess individual's dissociative state. A higher score represents more dissociation.
  • Self-reported responses as assessed by a clinician on the 18-item Brief Psychiatric Rating Scale (BPRS). [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    Responses are summed on a 7-point scale in rating one's severity to the statements as 'not assessed' to 'extremely severe'. Scores assess psychiatric symptoms like anxiety, depression, and psychoses. A higher score means the individual is presenting more extreme symptoms.
  • Steroid hormone assay via saliva collection [ Time Frame: Up to 5 hours after infusion of ketamine or placebo ]
    At 5 different time points throughout infusion visits the participant chews on a cotton swab for 30 seconds to collect saliva. A steroid hormone assay is conducted to collect data on cortisol, testosterone, progesterone, and estradiol levels.
Original Secondary Outcome Measures
 (submitted: March 21, 2018)
  • Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity [ Time Frame: Up to 5 hours after infusion of ketamine 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 infusion of ketamine 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 infusion of ketamine or placebo ]
    Responses are quantified as summed scores for negative and positive mood states
  • Level of subjectively experienced intoxication as assessed by a visual analogue intoxication scale [ Time Frame: Up to 5 hours after infusion of ketamine 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 Regulating Circuits of the Brain Study- Ketamine
Official Title Mapping the Influence of Drugs of Abuse on Risk and Reward Circuits
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 magnetic resonance imaging.

Participants will include volunteers who report more than two prior uses of ketamine (also known as "Special K"), when they were 18 years or older.

The investigators will recruit individuals who have previously tried ketamine rather than those who are ketamine-naïve.

Participants will receive an IV infusion of ketamine (~.05mg/kg and 0.5mg/kg) or placebo (saline). 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 ketamine infusion. Participants will also be monitored after the functional imaging session. Secondary effects of ketamine on behavior and self-reported experience will be assessed.

In the assessment of the acute effects of ketamine, the investigators will take into account the cumulative effects of prior drug exposure.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy volunteers with prior exposure to ketamine
Condition Healthy
Intervention Drug: Ketamine
Acute administration
Other Name: "special k"
Study Groups/Cohorts 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).

Intervention: Drug: Ketamine
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 Recruiting
Estimated Enrollment
 (submitted: March 21, 2018)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Nancy Gray (650) 736-6260 njgray@stanford.edu
Contact: Emily Zhai (650) 498-9326 emzhai@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03475277
Other Study ID Numbers 41173
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
Current Responsible Party Leanne Williams, Stanford University
Original Responsible Party Same as current
Current Study Sponsor Stanford University
Original Study Sponsor Same as current
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Leanne M Williams, PhD Study PI
PRS Account Stanford University
Verification Date April 2022