The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
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|ClinicalTrials.gov Identifier: NCT01535937|
Recruitment Status : Terminated (An analysis demonstrated that running the final participants was unnecessary.)
First Posted : February 20, 2012
Results First Posted : September 14, 2018
Last Update Posted : May 1, 2019
|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|
|Actual Primary Completion Date :||January 2017|
|Actual 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
- Number of Participants With Cocaine Use/Drop Out [ Time Frame: Over the four week period following discharge from the inpatient unit at Day 5 ]Number of participants who use cocaine and drop from study. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|