The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

• Status: Terminated
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Ketamine; Midazolam

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