Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET

Cocaine Dependence Clinical Trial

Official title:

Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527485
• Other study ID #: 2000021843
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 28, 2023

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 21-55 years;
• Voluntary, written, informed consent;
• Physically healthy by medical history, physical, neurological, ECG and laboratory examinations;
• DSM-5 criteria for Cocaine Use Disorder or 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)).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Diagnostic Test:
• 11UCB-J PET Scan
11UCB-J PET Scan

Locations

Country	Name	City	State
United States	CT Mental Health Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11C-UCB-J PET synaptic density	PET scan	90 minute scan