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Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

NCT03344419 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

  • Cocaine Use Disorder

Interventions

DRUG

CI-581a

Medication infusion intravenously over 1 hour.

DRUG

CI-581b

Medication infusion intravenously over 1 hour.

BEHAVIORAL

Motivational Enhancement Therapy (MET)

Manualized one on one therapy aimed at mobilizing motivation for change and for goals.

BEHAVIORAL

Mindfulness Based Relapse Prevention

Manualized one on one therapy aimed at mindfulness-based behavioral modification and the cultivation of relapse prevention skils.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Elias Dakwar, MD · NYSPI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344419 on ClinicalTrials.gov