The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
|ClinicalTrials.gov Identifier: NCT01535937|
Recruitment Status : Terminated (An analysis demonstrated that running the final participants was unnecessary.)
First Posted : February 20, 2012
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Ketamine Drug: Midazolam||Phase 1 Phase 2|
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 time to first use compared to placebo and MBRP in cocaine-dependent individuals.
- ketamine and MBRP is significantly more likely to lead to abstinence from cocaine (no use over one week) as compared to placebo and MBRP.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||February 2012|
|Primary Completion Date :||February 2017|
|Study Completion Date :||April 2017|
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
- Time to first cocaine use [ Time Frame: Over the four week period following discharge from the inpatient unit at Day 5 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535937
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Study Chair:||Herbert Kleber, M.D.||NYSPI|
|Principal Investigator:||Elias Dakwar, MD||New York State Psychiatric Institute|