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Glutamatergic Modulation of Cocaine-related Deficits

NCT01790490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-04-30

Study results available
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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 and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Ketamine 0.41 mg/kg

52 minute iv infusion of ketamine 0.41 mg/kg

DRUG

Ketamine 0.71 mg/kg

52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings.

DRUG

Lorazepam 2 mg

52 minute infusion of lorazepam 2 mg. This serves as an active control.

Sponsors & Collaborators

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Elias Dakwar, MD · NYSPI/Columbia College of Physicians and Surgeons

  • Carl Hart, PhD · NYSPI/Columbia College of Physicians and Surgeons

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
52 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790490 on ClinicalTrials.gov