Glutamatergic Modulation of Cocaine-related Deficits

Completed · Phase 2

Conditions studied: Cocaine Dependence

In brief

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.

Key facts

Study ID

NCT01790490

Run by

New York State Psychiatric Institute

People needed

8

Starts

2011-02-01

Expected to finish

2012-03-01

Last updated by the study team

2019-04-30

Who can join

Age: 21 and older, up to 52. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Physically healthy
• No adverse reactions to study medications
• 21-52 years of age
• Normal body weight
• Responsive to drug cues
• Capacity to consent

You may not qualify if…

• Seeking treatment or abstinence
• DSM IV criteria for substance dependence (other than methamphetamine, cocaine, cannabis, or nicotine), or DSM IV criteria for abuse of ketamine or lorazepam
• 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
• Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
• Current suicide risk or a history of suicide attempt within the past 2 years
• Current use of prescribed psychotropic medication
• Pregnancy, nursing, or had a baby within the past 6 mo.
• Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
• 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
• "Bad" reaction/experience with prior exposure to ketamine or lorazepam
• History of significant violence
• First degree relative with a psychotic disorder

Where it is running

• NYSPI — New York, New York, United States

Full record on ClinicalTrials.gov

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