Clinical Trials Logo

Clinical Trial Summary

The proposed research program will investigate the changes in brain chemistry and circuitry that 're-wire' the brain during chronic cocaine use, promote relapse, and complicate treatment efforts. Currently-using and non-treatment-seeking individuals with a cocaine use disorder will undergo a cocaine self-administration paradigm 2-5 days prior to completing positron emission tomography (PET) and functional magnetic resonance imaging (fMRI).


Clinical Trial Description

Cocaine use disorder (CUD) remains a significant public health concern that is resistant to current treatments. Challenges to treating CUD include an imbalance in neurobiological systems that 're-wire' the brain such that appetitive and habitual processes influence decision-making and behavior. This research project aims to provide insight into this reorganized circuitry in CUD by investigating neurofunctional systems related to glutamatergic plasticity and functional brain networks during initial (2-5 days) abstinence. To target this potentially critical period of recovery, currently-using and non-treatment-seeking individuals with CUD will undergo a cocaine self-administration paradigm 2-5 days prior to completing [18F]FPEB positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Healthy comparison (HC) subjects that have participated in [18F]FPEB PET as part of other Yale approved protocols will be recruited to participate in the fMRI portion of this study.

Aim 1: To determine the availability of mGluR5 using [18F]FPEB PET during initial abstinence in individuals with CUD. The investigators hypothesize individuals with CUD, relative to HC, will exhibit concurrently and regionally specific increases (e.g., in the striatum) and decreases (e.g., in the prefrontal cortex) in mGluR5 availability.

Aim 2: To determine patterns of resting-state, response-inhibition, an automaticity related connectivity within and between large-scale functional networks using fMRI during initial abstinence in individuals with CUD. The investigators hypothesize network-based analyses of fMRI will reveal lower frontoparietal and greater limbic network modulation in CUD as compared to HC.

Aim 3: To explore the relationships between mGluR5 availability and functional network activity during initial abstinence in individuals with CUD. The investigators will perform multi-modal analysis of PET and fMRI data to examine links between molecular and functional systems in CUD using emerging 'fusion' approaches. While exploratory in nature, the investigators expect to find links between alterations in mGluR5 systems and functional reorganization in CUD (e.g., greater dorsostriatal mGluR5 may be linked to blunted frontoparietal inhibition).

Aim 4: To explore the relationships between mGluR5 availability, functional network activity (and their linkages) with cocaine self-administration, disease severity and chronicity, and psychometric assessments of impulsivity and compulsivity. While exploratory in nature, the investigators expect more substantial neurofunctional alterations during initial abstinence will be associated with greater cocaine self-administration, disease severity, impulsivity and compulsivity in individuals with CUD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03471182
Study type Interventional
Source Yale University
Contact Jessica Costeines, MA
Phone 203-974-7559
Email jessica.costeines@yale.edu
Status Recruiting
Phase Phase 1
Start date February 26, 2018
Completion date June 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03266939 - Rebalancing the Serotonergic System in Cocaine Dependence Phase 1
Completed NCT02563769 - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study Phase 1
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Completed NCT01402492 - Cocaine Use Reduction With Buprenorphine Phase 2/Phase 3
Completed NCT00880997 - The Efficacy of Doxazosin for Cocaine Users Phase 1
Completed NCT00585520 - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues Phase 1
Completed NCT00566969 - Cocaine Withdrawal and Pharmacotherapy Response N/A
Completed NCT00368290 - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior Phase 2
Completed NCT00322309 - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects Phase 2
Completed NCT00385801 - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence Phase 2
Completed NCT00842517 - Long Term Maintenance of Drug Abstinence Phase 1
Completed NCT00167245 - Topiramate for Alcohol and Cocaine Dependence Phase 2
Recruiting NCT02927236 - Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use Phase 1/Phase 2
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Active, not recruiting NCT02018263 - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans N/A
Withdrawn NCT01406522 - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics Phase 2
Completed NCT01573273 - Oxytocin in Cocaine Dependence N/A
Completed NCT01651377 - Pramipexole as a Treatment for Cocaine Dependence Phase 1
Completed NCT02098434 - Ovarian Hormones and Stress Induced Drug Craving N/A
Completed NCT01153477 - Effectiveness of Enhanced Treatments for Drug Dependence Phase 2