Last reviewed · How we verify

NCT03471182

Investigation of Cocaine Addiction Using mGluR5 PET and fMRI

Completed Phase 1 Results posted Last updated 29 February 2024
What this trial tests

Phase 1 trial testing Psychiatric and Cognitive Testing in Cocaine Dependence in 32 participants. Completed in 18 August 2022.

Timeline
26 February 2018
Primary endpoint
18 August 2022
18 August 2022

Quick facts

Lead sponsorYale University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment32
Start date26 February 2018
Primary completion18 August 2022
Estimated completion18 August 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

Adults 18 to 60, any sex, with Cocaine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Regional Availability of Metabotropic Glutamate Type-5 Receptors (mGluR5) Primary · Following 2-5 days of cocaine abstinence

Receptor availability assessed as the volume of distribution (VT) of \[18F\]FPEB radiotracer, measured using positron emission tomography (PET). Higher \[18F\]FPEB VT values indicate a greater availability of mGluR5 receptors.

Ventral striatum
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)36.48± 8.05
Historical Healthy Comparison Adults, PET (HHC-PET)32.19± 5.58
Caudate
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)25.67± 7.29
Historical Healthy Comparison Adults, PET (HHC-PET)22.41± 4.75
Putamen
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)30.31± 5.84
Historical Healthy Comparison Adults, PET (HHC-PET)26.06± 5.26
Orbitofrontal cortex
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)30.40± 6.13
Historical Healthy Comparison Adults, PET (HHC-PET)26.36± 4.61
Anterior cingulate cortex
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)32.54± 6.88
Historical Healthy Comparison Adults, PET (HHC-PET)28.73± 5.54
Ventromedial prefrontal cortex
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)33.95± 7.21
Historical Healthy Comparison Adults, PET (HHC-PET)29.41± 5.34
Inferior frontal gyrus
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)28.42± 6.08
Historical Healthy Comparison Adults, PET (HHC-PET)24.78± 4.25
Middle frontal gyrus
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)28.37± 6.94
Historical Healthy Comparison Adults, PET (HHC-PET)24.95± 4.36
Functional Brain Network Engagement Associated With Response Inhibition Primary · Following 2-5 days of cocaine abstinence.

Independent component analysis (ICA) of functional MRI data separates brain activity associated with distinct functional networks. Comparing the activity in these networks to the fMRI task events using a regression analysis produces a beta-weight where a larger beta indicates the network was more activated or 'engaged' in processing the task demands. In this study, participants completed a Go/NoGo task to assess brain processing associated with infrequent-stimulus response inhibition (i.e., correct NoGo's) compared to frequent-stimulus responses (i.e., correct Go's).

Right frontoparietal network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.409± 0.103
Healthy Comparison Adults, MRI (HC-MRI)0.125± 0.156
Left frontoparietal network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.349± 0.159
Healthy Comparison Adults, MRI (HC-MRI)0.037± 0.241
Basal ganglia network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.175± 0.103
Healthy Comparison Adults, MRI (HC-MRI)-0.240± 0.156
Cingulo-insula network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.103± 0.121
Healthy Comparison Adults, MRI (HC-MRI)-0.271± 0.183
Resting-state Functional Brain Network Activity, Fractional Amplitude of Low-frequency Fluctuations (fALFF) Primary · Following 2-5 days of cocaine abstinence.

Independent component analysis (ICA) of functional MRI data separates brain activity associated with distinct functional networks. The fractional amplitude of low-frequency fluctuations (fALFF) during resting-state reflects a measure of the general health status of a network, comprised of both the strength of network activity and within-network connectivity absent of any specific cognitive demands.

Default-mode network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.747± 0.021
Healthy Comparison Adults, MRI (HC-MRI)0.726± 0.030
Right frontoparietal network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.749± 0.019
Healthy Comparison Adults, MRI (HC-MRI)0.772± 0.026
Left frontoparietal network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.739± 0.021
Healthy Comparison Adults, MRI (HC-MRI)0.734± 0.030
Basal ganglia network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.636± 0.036
Healthy Comparison Adults, MRI (HC-MRI)0.590± 0.051
Cingulo-insula network
GroupValue95% CI
Adults With a Cocaine-use Disorder (CUD)0.707± 0.029
Healthy Comparison Adults, MRI (HC-MRI)0.726± 0.041

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cocaine self-administration behavior is associated with subcortical and cortical morphometry measures in individuals with cocaine use disorder.
    Kohler RJ, Zhornitsky S, Potenza MN, Yip SW, et al · · 2024 · PMID 38551365 · DOI 10.1080/00952990.2024.2318585

Verify or expand the search:

Other recruiting trials for Cocaine Dependence

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03471182.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing