Status:
COMPLETED
Investigation of Cocaine Addiction Using mGluR5 PET and fMRI
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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. Curr...
Detailed Description
Cocaine use disorder (CUD) remains a significant public health concern that is resistant to current treatments. Challenges to treating CUD include an imbalance in neurobiological systems that 're-wire...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03471182
Start Date
February 26 2018
End Date
August 18 2022
Last Update
February 29 2024
Active Locations (1)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519