Back to resultsThe Effect of Glutamatergic Modulation on Cocaine Self-administration
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CI-581a
CI-581b
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence
Eligibility Criteria
Inclusion Criteria:
- 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
- Physically healthy
- No adverse reactions to study medications
- 21-55 years of age
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
- Not seeking treatment
Exclusion Criteria:
- 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.
- Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
- Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
- Current suicide risk or a history of suicide attempt within the past year
- Pregnant or interested in becoming pregnant during the study period
- Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- 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
- 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
- Recent history of significant violence (past 2 years)
- Abnormal pseudocholinesterase level
- First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
- BMI > 35, or a history of documented obstructive sleep apnea
- On psychotropic or other medications whose effect could be disrupted by participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CI-581a
CI-581b
Arm Description
Administration of CI-581a followed 2 weeks later by CI-581b
Administration of CI-581b followed 2 weeks later by CI-581a
Outcomes
Primary Outcome Measures
Number of Choices to Self-administer Cocaine (Out of 5 Choices)
Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.
Secondary Outcome Measures
Full Information
NCT ID
NCT02596022
First Posted
November 2, 2015
Last Updated
June 13, 2018
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT02596022
Brief Title
The Effect of Glutamatergic Modulation on Cocaine Self-administration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI-581a
Arm Type
Experimental
Arm Description
Administration of CI-581a followed 2 weeks later by CI-581b
Arm Title
CI-581b
Arm Type
Active Comparator
Arm Description
Administration of CI-581b followed 2 weeks later by CI-581a
Intervention Type
Drug
Intervention Name(s)
CI-581a
Intervention Description
a 50 minute infusion 24 hours prior to cocaine self-administration session
Intervention Type
Drug
Intervention Name(s)
CI-581b
Intervention Description
a 50 minute infusion 24 hours prior to cocaine self-administration session
Primary Outcome Measure Information:
Title
Number of Choices to Self-administer Cocaine (Out of 5 Choices)
Description
Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.
Time Frame
24 hours post-infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Physically healthy
No adverse reactions to study medications
21-55 years of age
Capacity to consent and comply with study procedures, including sufficient proficiency in English
Not seeking treatment
Exclusion Criteria:
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.
Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
Current suicide risk or a history of suicide attempt within the past year
Pregnant or interested in becoming pregnant during the study period
Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
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
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
Recent history of significant violence (past 2 years)
Abnormal pseudocholinesterase level
First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
BMI > 35, or a history of documented obstructive sleep apnea
On psychotropic or other medications whose effect could be disrupted by participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, MD
Organizational Affiliation
Columbia College of Physicians and Surgeons
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effect of Glutamatergic Modulation on Cocaine Self-administration
We'll reach out to this number within 24 hrs