NCT03344419

Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2017-11-17
• Last updated: 2024-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study