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

Cocaine Dependence

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

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source