The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

Stopped early · Phase 1/Phase 2

Conditions studied: Cocaine Dependence

In brief

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.

Key facts

Study ID

NCT01535937

Run by

New York State Psychiatric Institute

People needed

55

Starts

2012-02-01

Expected to finish

2017-04-01

Last updated by the study team

2019-05-01

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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