Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
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ClinicalTrials.gov Identifier: NCT03344419 |
Recruitment Status :
Recruiting
First Posted : November 17, 2017
Last Update Posted : February 5, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | November 13, 2017 | ||||||||
First Posted Date ICMJE | November 17, 2017 | ||||||||
Last Update Posted Date | February 5, 2020 | ||||||||
Actual Study Start Date ICMJE | October 1, 2017 | ||||||||
Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Abstinence from Cocaine Use [ Time Frame: from baseline to week 12 ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders | ||||||||
Official Title ICMJE | Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders | ||||||||
Brief Summary | Changes in the communication of glutamate from one brain structure to another are important in the development of therapy for cocaine use disorders. Our preliminary investigations suggest that drugs that affect glutamate exchange may be effective at promoting and maintaining individuals' abstinence from cocaine. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cocaine use disorders. | ||||||||
Detailed Description | Alterations in the transmission between neurons of a neurotransmitter called glutamate are an important target of pharmacotherapy for cocaine use disorders (CUDs). Preliminary investigations suggest that glutamate modulation may be effective at promoting and maintaining abstinence and that it promotes motivation to quit, reduces craving, reduces cocaine self-administration and facilitates abstinence in individuals with a CUD in a series of trials. The study team has recently developed and tested a novel design that integrates a clinical trial involving serial infusions and a behavioral treatment platform. The current trial will evaluate the effect of two sub-anesthetic infusions on abstinence rates in a relatively large sample of treatment-seeking CUD individuals who complete a 12-week double-blind, randomized, controlled trial. It will also evaluate the correlation between clinical response and brain-derived neurotrophic factor (BDNF), a peripheral biomarker relevant to glutamate modulation antidepressant response. This project aims to expand on several years of promising preliminary data to rigorously evaluate the efficacy of this innovative pharmacological intervention integrated into a behavioral treatment platform. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cocaine Use Disorder | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
150 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2021 | ||||||||
Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 60 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03344419 | ||||||||
Other Study ID Numbers ICMJE | 7461 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Elias Dakwar, New York State Psychiatric Institute | ||||||||
Study Sponsor ICMJE | New York State Psychiatric Institute | ||||||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | New York State Psychiatric Institute | ||||||||
Verification Date | January 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |