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Glutamatergic Modulation of Cocaine-related Deficits

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence Related Impairments in Motivation for Change, and in Cue-induced Arousal

Intervention: Ketamine 0.41 mg/kg (Drug); ketamine 0.71 mg/kg (Drug); lorazepam 2 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Elias Dakwar, MD, Principal Investigator, Affiliation: NYSPI/Columbia College of Physicians and Surgeons
Carl Hart, PhD, Study Chair, Affiliation: NYSPI/Columbia College of Physicians and Surgeons

Summary

Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators, studies with human subjects have been unsuccessful to date. The purpose of this investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving in cocaine dependent and on impaired motivation for quitting cocaine participants, 24-hours post-infusion.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in Cue Reactivity

Change in Motivation

Secondary outcome:

Acute tolerability

Risk of initiating experimental drug misuse

Eligibility

Minimum age: 21 Years. Maximum age: 52 Years. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Active free-base cocaine dependence (at least 4 days of use over the past month, with at least 1 use per week); if the participant uses through another route (IN, IV), then the FB route is dominant (> 80% of occasions). 2. Physically healthy 3. No adverse reactions to study medications 4. 21-52 years of age 5. Normal body weight 6. Responsive to drug cues 7. Capacity to consent Exclusion Criteria: 1. Seeking treatment or abstinence 2. DSM IV criteria for substance dependence (other than methamphetamine, cocaine, cannabis, or nicotine), or DSM IV criteria for abuse of ketamine or lorazepam 3. DSM-IV criteria for other Axis I psychiatric illness that may make participation hazardous such as schizophrenia, schizoaffective disorder, psychosis NOS, MDD, psychosis secondary to substances, or bipolar disorder 4. Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders 5. Current suicide risk or a history of suicide attempt within the past 2 years 6. Current use of prescribed psychotropic medication 7. Pregnancy, nursing, or had a baby within the past 6 mo. 8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery. 9. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease, or diabetes 10. "Bad" reaction/experience with prior exposure to ketamine or lorazepam 11. History of significant violence 12. First degree relative with a psychotic disorder

Locations and Contacts

NYSPI, NY, New York 10032, United States
Additional Information

Starting date: February 2011
Last updated: February 11, 2013

Page last updated: August 23, 2015

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