The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
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. T
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Time to first cocaine use [ Time Frame: Over the four week period following discharge from the inpatient unit at Day 5 ] [ Designated as safety issue: No ]During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.
- Abstinence [ Time Frame: Abstinence will be assessed over 4 weeks starting at the last day of week 1 and continuing through the end of study at the last day of week 5 ] [ Designated as safety issue: No ]Abstinence is defined as 2 or greater weeks of no cocaine use, as ascertained by the TLFB and urine toxicology.
- Stress and cue reactivity [ Time Frame: This will be assessed over the five week course of the trial; on days 1 and 5, on the last day of week 2, and on the last day of week 5 ] [ Designated as safety issue: No ]Self-assessments as well as endocrine, physiological, and other assessments are used to ascertain stress and cue reactivity as well as craving at the above-mentioned time-points as well as, in some cases, continuously over the five week period of the trial.
- Mindfulness [ Time Frame: This will be assessed over the five week course of the trial; on days 1 and 5, on the last day of week 2, and on the last day of week 5 ] [ Designated as safety issue: No ]The Five Facet Mindfulness Questionnaire will be administered at various points throughout the study in order to ascertain the effect of the intervention on mindfulness as compared to the control.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
0.5 mg/kg of ketamine IV over 40 minutes
0.5 mg/kg IV over 40 minutes
Other Name: ketamine 0.5 mg/kg
Active Comparator: midazolam
0.025 mg/kg IV over 40 minutes
0.025 mg/kg IV over 40 minutes
Other Name: midazolam 0.025 mg/kg
he study will begin with an inpatient phase (phase 1) of 5 days, during which abstinence is achieved, followed by a 4 week outpatient phase (phase 2). A single infusion of ketamine or midazolam will occur on day 3 of Phase 1. In addition to measures of mindfulness and impulsivity, stress sensitivity tests are incorporated into the design in order to elucidate mechanisms of action. The study hypotheses are:
- ketamine and MBRP will significantly increase the ti
- ketamine and MBRP is significantly more likely to lead to abstinence from cocaine (no use over one week) as compared to placebo and MBRP.me to first use compared to placebo and MBRP in cocaine-dependent individuals.
- ketamine and MBRP will significantly reduce subjective, endocrine, and physiological responses to stress (including cue exposure) as compared to placebo and MBRP.
- ketamine and MBRP will significantly increase mindfulness, as assessed by the Five Facet Mindfulness Questionnaire (FFMQ), as compared to placebo and MBRP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535937
|Contact: Elias Dakwar, M.D.||(646) firstname.lastname@example.org|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Elias Dakwar, M.D.|
|Principal Investigator: Elias Dakwar, M.D.|
|Study Chair:||Herbert Kleber, M.D.||NYSPI|
|Principal Investigator:||Elias Dakwar, MD||New York State Psychiatric Institute|