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
Group
Value
95% CI
Adults With a Cocaine-use Disorder (CUD)
36.48
± 8.05
Historical Healthy Comparison Adults, PET (HHC-PET)
32.19
± 5.58
Caudate
Group
Value
95% CI
Adults With a Cocaine-use Disorder (CUD)
25.67
± 7.29
Historical Healthy Comparison Adults, PET (HHC-PET)
22.41
± 4.75
Putamen
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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 InhibitionPrimary· 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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):
NCT06189690 — Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder
· NA
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 29 February 2024
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.