CompletedPhase 2ketamine

Glutamatergic Modulation of Cocaine-related Deficits

NCT ID

NCT01790490

Target Enrollment

8 participants

Start Date

2011-02

Est. Completion

2012-03

About This Study

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 Studied

Cocaine Dependence

Interventions

•Ketamine 0.41 mg/kg
•Ketamine 0.71 mg/kg
•Lorazepam 2 mg

Eligibility

Age:21 Years - 52 Years

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

NYSPI

New York, New York, United States