Investigation of Cocaine Addiction Using mGluR5 PET and fMRI

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine

Criteria

Inclusion Criteria:

• All participants:

• Age 21 - 55 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