Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
2 other identifiers
interventional
41
1 country
1
Brief Summary
This study aims to measure synaptic density in the brains (including in ventral striatum \[VS\] and medial prefrontal cortex \[mPFC\]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan. This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedResults Posted
Study results publicly available
July 16, 2024
CompletedJuly 16, 2024
June 1, 2024
4.2 years
April 19, 2018
February 23, 2024
June 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
11C-UCB-J PET Synaptic Density
PET scan- Participants underwent a single 11C-UCB-J PET scan to obtain measures of synaptic density (BPND). Structural magnetic resonance imaging (MRI) scans were also obtained for anatomical registration/partial volume correction (PVC) with the iterative Yang (IY) algorithm. BPND is a unitless metric. The study aimed to explore synaptic density differences in subjects with opioid use disorder compared to a control group within the sample.
90 minute scan
Study Arms (2)
Opiate Use Disorder (OUD)
OTHER30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan.
Healthy Controls (HC)
OTHER30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan.
Interventions
Eligibility Criteria
You may qualify if:
- Age 21-55 years;
- Voluntary, written, informed consent;
- Physically healthy by medical history, physical, neurological, ECG and laboratory examinations;
- DSM-5 criteria for Opiate Use Disorder;
- Documented evidence (by urine toxicology) of 2 weeks abstinence from cocaine and 4 weeks abstinence from opiates;
- For females, a negative serum pregnancy (HCG) test;
- Full scale and verbal IQs \> 80 (Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)).
You may not qualify if:
- A history of other substance dependence (e.g., alcohol, sedative hypnotics), except for nicotine;
- A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID-5);
- A history of significant and uncontrolled medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizures, traumatic brain injury) illness;
- A history of seizures;
- Current use of psychotropic and/or potentially psychoactive prescription medications;
- Medical contraindications to participation in a magnetic resonance (MR) imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.) as recorded on the MR safety sheet;
- For females, physical or laboratory (HCG) evidence of pregnancy;
- PTT and PT/INR lab results not appropriate for arterial line placement;
- Taking anticoagulants;
- Being prescribed methadone/buprenorphine upon screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
CT Mental Health Center
New Haven, Connecticut, 06519, United States
Related Publications (1)
Innis RB, Cunningham VJ, Delforge J, Fujita M, Gjedde A, Gunn RN, Holden J, Houle S, Huang SC, Ichise M, Iida H, Ito H, Kimura Y, Koeppe RA, Knudsen GM, Knuuti J, Lammertsma AA, Laruelle M, Logan J, Maguire RP, Mintun MA, Morris ED, Parsey R, Price JC, Slifstein M, Sossi V, Suhara T, Votaw JR, Wong DF, Carson RE. Consensus nomenclature for in vivo imaging of reversibly binding radioligands. J Cereb Blood Flow Metab. 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493. Epub 2007 May 9.
PMID: 17519979BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gustavo A. Angarita, MD, MHS
- Organization
- Yale School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2018
First Posted
May 17, 2018
Study Start
January 1, 2019
Primary Completion
March 28, 2023
Study Completion
March 28, 2023
Last Updated
July 16, 2024
Results First Posted
July 16, 2024
Record last verified: 2024-06