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Phase 1 N=45 Other

Investigation of Cocaine Addiction Using mGluR5 PET and fMRI

Cocaine Dependence

Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Regional Availability of Metabotropic Glutamate Type-5 Receptors (mGluR5) — 36.48; 32.19; 25.67; 22.41 mL*cm^3 — p=0.035

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Psychiatric and Cognitive Testing (Behavioral); Cocaine Self-adminstration (Drug); Positron Emission Tomography (Radiation); Magnetic Resonance Imaging (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Regional Availability of Metabotropic Glutamate Type-5 Receptors (mGluR5)
36.48; 32.19; 25.67; 22.41; 30.31; 26.06 0.035 sig
PRIMARY
Functional Brain Network Engagement Associated With Response Inhibition
0.409; 0.125; 0.349; 0.037; 0.175; -0.240 0.024 sig
PRIMARY
Resting-state Functional Brain Network Activity, Fractional Amplitude of Low-frequency Fluctuations (fALFF)
0.747; 0.726; 0.749; 0.772; 0.739; 0.734 0.870

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).

Eligibility Criteria

Inclusion Criteria

  • All participants:
  • Age 21 - 60 years
  • Provide voluntary, written, informed consent
  • Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
  • For females: non-lactating, no longer of child-bearing potential or agreeing to practice effective contraception during the study (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine system [IUS]; barrier methods: condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence when this is in line with the preferred and usual lifestyle of the subject), and a negative serum pregnancy test
  • Participants with a cocaine use disorder:
  • DSM-5 criteria for moderate or severe cocaine-use disorder
  • Recent street cocaine use in excess of quantities used in the current study
  • Intravenous and/or smoked (crack/freebase) cocaine use
  • Positive urine toxicology screen for cocaine
  • Healthy comparison participants:
  • Successful completion of an [18F]FPEB scan as part of another Yale approved protocol as a healthy control/comparison subject

Exclusion Criteria

  • All participants:
  • Any condition that, in the opinion of investigators, would prevent compliance with the study protocol
  • A history of significant medical or neurological illness (e.g., coronary artery disease, significant anemia, seizures)
  • Current use of psychotropic and/or potentially psychoactive medications
  • Physical or laboratory evidence of pregnancy
  • Meet any additional PET/MR imaging-related exclusion criteria, including:
  • Presence of MRI incompatible implants and other contraindications for MRI (e.g., pacemaker, artificial joints, non-removable body piercings, etc.)
  • Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the participant to exceed the yearly dose limits
  • History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
  • Claustrophobia
  • Severe motor problems that prevent the subject from lying still for PET/MR imaging
  • Complaints of chronic pain (e.g., as the result of rheumatoid arthritis)
  • Current, past or anticipated exposure to radiation in the work place
  • Participants with a cocaine use disorder:
  • Other drug use disorder (except for tobacco-use disorder)
  • Less than 1 year of cocaine use disorder
  • A DSM-5 major psychiatric diagnosis (schizophrenia, bipolar disorder, etc.) unrelated to cocaine
  • Healthy comparison participants:
  • Any DSM-5 major psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), except tobacco-use disorder
  • Positive drug screen
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03471182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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