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Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

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ClinicalTrials.gov Identifier: NCT02373124
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : April 24, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE February 26, 2015
Results First Submitted Date  ICMJE January 25, 2019
Results First Posted Date  ICMJE April 24, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
Cocaine Use [ Time Frame: 5 weeks ]
Participants were provided choices to use up to 5 hits of cocaine on up to 2 occasions (cocaine versus money). Participants who chose cocaine (1 or more hits) during the first choice opportunity are administered a 52 minute infusion of 0.71 mg/kg ketamine the following day. Another choice opportunity occurs 24 hours later. The primary outcome is the choice participants made during these occasions
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Cocaine Use, as assessed by urine toxicology and time-line follow back [ Time Frame: 5 weeks ]
investigation of whether cocaine use worsens as a result of naturalistic use opportunities; this will be assessed by urine toxicology and time-line follow back
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial
Official Title  ICMJE Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial
Brief Summary This study evaluates the feasibility of a treatment paradigm that involves naturalistic cocaine use opportunities in the context of psychotherapy aimed at utilizing these opportunities therapeutically.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Use Disorders
Intervention  ICMJE Drug: infusion of NMDA antagonist
52 minute infusion
Other Name: NMDA antagonist
Study Arms  ICMJE Experimental: open-label
52 minute infusion of NMDA antagonist
Intervention: Drug: infusion of NMDA antagonist
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2015)
8
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criterion Method of Ascertainment

  1. Active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening SCID, Psychiatric Interview, self-report, utox
  2. Physically healthy Laboratory tests (urinalysis, blood chemistry, 12-lead ECG in normal limits), physical examination, self-reported medical history
  3. No adverse reactions to study medications Subjects will be asked about previous exposure to ketamine and midazolam
  4. 21-55 years of age Self-reported age, verification with legal identification
  5. Capacity to consent and comply with study procedures, including sufficient proficiency in English A short written test about study procedures, SCID, psychiatric interview
  6. Seeking treatment Psychiatric Interview, self-report

Exclusion Criterion Method of Ascertainment

  1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with HAMD score > 12. Psychiatric Interview, SCID, HAMD
  2. Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis SCID, Psychiatric Interview
  3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders SCID, Psychiatric Interview
  4. Current suicide risk or a history of suicide attempt within the past year SCID, Psychiatric Interview
  5. Pregnant or interested in becoming pregnant during the study period Blood and urine pregnancy testing, self-report
  6. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse Laboratory tests (12-lead ECG in normal limits), physical examination, self-reported medical history
  7. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), WBC < 3.5, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creat > 2, BUN >40), or untreated diabetes Physiological tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, self-reported medical history
  8. Previous history of ketamine or midazolam misuse or abuse, and a history of an adverse reaction/experience with prior exposure to cocaine, ketamine or midazolam Physical examination, self-reported medical history
  9. Recent history of significant violence (past 2 years) SCID, Psychiatric Interview
  10. Abnormal pseudocholinesterase level Blood testing
  11. First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS) SCID, Psychiatric Interview
  12. BMI > 35, or a history of documented obstructive sleep apnea Physical examination, self-reported medical history
  13. On psychotropic or other medications whose effect could be disrupted by participation in the study Psychiatric interview, self-reported medical history
  14. Patients who cannot comply with study procedures during the initial hospitalization phase Study Performance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373124
Other Study ID Numbers  ICMJE 7051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elias Dakwar, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: elias dakwar NYSPI
PRS Account New York State Psychiatric Institute
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP