CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Cocaine Self-adminstration +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03471182
NCT03471182Phase 1Completed

Investigation of Cocaine Addiction Using mGluR5 PET and fMRI

Yale University·interventional·Posted Mar 20, 2018·Updated Feb 29, 2024

In Brief

A Phase 1 clinical trial evaluating Psychiatric and Cognitive Testing, Cocaine Self-adminstration, and 2 other interventions for Cocaine Dependence. Completed, enrolled 32 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 20, 2018
Enrollment StartFeb 26, 2018
Primary CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.3 years ago

Interventions

Psychiatric and Cognitive Testingbehavioral

Interviews, questionnaires, and computer testing.

Cocaine Self-adminstrationdrug

The intervention will include a training and safety session that consists of physician/nurse-administered cocaine followed by a self-regulated cocaine administration period under carefully controlled and closely monitored conditions.

Positron Emission Tomographyradiation

PET scans will be performed on a High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available. Antecubital venous catheters will be used for IV administration of the radiotracer and for venous blood sampling. A radial artery catheter may also be inserted by an experienced physician before the PET scan. At the beginning of each scan, the participants's head will be immobilized and a 6-minute transmission scan, using an orbiting 137Cs point-source, is obtained and used for attenuation correction. PET scans will be acquired using bolus or bolus plus constant infusion administration of \[18F\]FPEB.

Magnetic Resonance Imagingother

Structural and functional MRI data will be acquired using a Siemens Trio TIM 3.0T system at the Yale Magnetic Resonance Research Center. High-resolution structural MRI data will be acquired to facilitate analysis of PET data and may be used in additional analysis of tissue volume and brain structure. Resting-state and task-based functional MRI data will be acquired using state-of-the-art multiband echo-planar imaging (EPI) gradient-echo sequences. Diffusion-weighted MRI data will also be acquired using multiband imaging sequences to investigate anatomical connectivity.