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The Effect of Glutamatergic Modulation on Cocaine Self-administration

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ClinicalTrials.gov Identifier: NCT02596022
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : October 17, 2017
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE November 4, 2015
Results First Submitted Date  ICMJE August 7, 2017
Results First Posted Date  ICMJE October 17, 2017
Last Update Posted Date June 15, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
Number of Choices to Self-administer Cocaine (Out of 5 Choices) [ Time Frame: 24 hours post-infusion ]
Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
number of choices to self-administer cocaine (out of 5 choices) [ Time Frame: 24 hours post-infusion ]
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 The Effect of Glutamatergic Modulation on Cocaine Self-administration
Official Title  ICMJE Not Provided
Brief Summary Repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. Converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. Using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of CI-581a on cocaine self-administration as compared to the active control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE
  • Drug: CI-581a
    a 50 minute infusion 24 hours prior to cocaine self-administration session
  • Drug: CI-581b
    a 50 minute infusion 24 hours prior to cocaine self-administration session
Study Arms  ICMJE
  • Experimental: CI-581a
    Administration of CI-581a followed 2 weeks later by CI-581b
    Interventions:
    • Drug: CI-581a
    • Drug: CI-581b
  • Active Comparator: CI-581b
    Administration of CI-581b followed 2 weeks later by CI-581a
    Interventions:
    • Drug: CI-581a
    • Drug: CI-581b
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: September 14, 2017)
18
Original Actual Enrollment  ICMJE
 (submitted: November 2, 2015)
20
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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
  2. Physically healthy
  3. No adverse reactions to study medications
  4. 21-55 years of age
  5. Capacity to consent and comply with study procedures, including sufficient proficiency in English
  6. Not seeking treatment

Exclusion Criteria:

  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.
  2. Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
  3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
  4. Current suicide risk or a history of suicide attempt within the past year
  5. Pregnant or interested in becoming pregnant during the study period
  6. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
  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
  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
  9. Recent history of significant violence (past 2 years)
  10. Abnormal pseudocholinesterase level
  11. First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
  12. BMI > 35, or a history of documented obstructive sleep apnea
  13. On psychotropic or other medications whose effect could be disrupted by participation in the study
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02596022
Other Study ID Numbers  ICMJE 6716
Has Data Monitoring Committee No
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, MD Columbia College of Physicians and Surgeons
PRS Account New York State Psychiatric Institute
Verification Date June 2018

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