TerminatedPhase 1ketamine
The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
Sponsored by New York State Psychiatric Institute
NCT ID
NCT01535937
Target Enrollment
55 participants
Start Date
2012-02
Est. Completion
2017-04
About This Study
This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.
Conditions Studied
Interventions
- •Ketamine
- •Midazolam
Eligibility
Age:21 Years - 60 Years
Healthy Volunteers:No
View full 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 * 21-60 years of age * Capacity to consent and comply with study procedures, including sufficient proficiency in English * 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 requiring medical management, 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 * 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), 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 (creatinine \> 2, BUN \>40), or untreated diabetes * Previous history of ketamine or benzodiazepine misuse or abuse, and a history of an adverse reaction/experience with prior exposure to ketamine or benzodiazepine * Recent history of significant violence (past 2 years) * First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS) * BMI \> 32, or a history of documented obstructive sleep apnea * On psychotropic or other medications whose effect could be disrupted by participation in the study * Patients who cannot comply with study procedures during the initial hospitalization phase
Study Locations (1)
New York State Psychiatric Institute
New York, New York, United States