Phase 1
N=45
Investigation of Cocaine Addiction Using mGluR5 PET and fMRI
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03471182 ↗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
| Outcome | Result | p-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
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.