Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03344419
Study type Interventional
Source New York State Psychiatric Institute
Contact Elias Dakwar, MD
Phone 646-774-6117
Email elias.dakwar@nyspi.columbia.edu
Status Recruiting
Phase Phase 3
Start date October 1, 2017
Completion date April 2024

See also
  Status Clinical Trial Phase
Completed NCT03538548 - Treatment Outcome in CBT for Cocaine Use N/A
Recruiting NCT04994821 - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study Phase 2
Not yet recruiting NCT06050304 - CRACK-TARGET 1: ÉTUDE DESCRIPTIVE DE LA SENSIBILISATION COMPORTEMENTALE OBSERVÉE et ATTENTES
Completed NCT02233647 - Phendimetrazine and Cocaine Early Phase 1
Completed NCT02239913 - Topiramate-Phentermine Combinations for Cocaine Dependence Phase 1
Not yet recruiting NCT05974202 - rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder Phase 2
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Completed NCT03224546 - Cocaine Use Reduction and Health N/A
Recruiting NCT03656653 - Imagery-based Coping for Cocaine Use Disorder N/A
Completed NCT03348384 - [11C]NOP-1A and Cocaine Use Disorders Early Phase 1
Recruiting NCT05019430 - Cocaine and Zolmitriptan Early Phase 1
Recruiting NCT05507814 - Temporal Window and Episodic Future Thinking in CUD N/A
Active, not recruiting NCT03799341 - Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project N/A
Completed NCT02785406 - Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use Phase 2
Completed NCT02798627 - Trial Of NS2359 For The Treatment of Cocaine Dependence Phase 2
Completed NCT02444208 - A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use N/A
Recruiting NCT05902819 - Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories N/A
Recruiting NCT05833529 - Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder N/A
Recruiting NCT05521854 - Contingency Management for Drug Use: Does Age Matter? N/A
Completed NCT05557149 - Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving in Cocaine Users N/A