Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

Ketamine

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.

Intervention / Treatment

  • Drug: CI-581a
  • Drug: CI-581b
  • Behavioral: Motivational Enhancement Therapy (MET)
  • Behavioral: Mindfulness Based Relapse Prevention

Condition or Disease

  • Cocaine Use Disorder

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 21 Years to 60 Years   (Adult)
Enrollment: 150 ()
Funded by: Other|NIH

Masking

Clinical Trial Dates

Start date: Oct 01, 2017
Primary Completion: Apr 21, 2020
Completion Date: Apr 21, 2020
Study First Posted: Nov 17, 2017
Results First Posted: Aug 31, 2020
Last Updated: Feb 05, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

New York, New York, USA

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.

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 60

This clinical trial is recruiting

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More Details

NCT Number: NCT03344419
Other IDs: 7461
Study URL: https://ClinicalTrials.gov/show/NCT03344419
Last updated: Jan 27, 2021