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

Primary Purpose

Opiate Dependence, Cocaine Dependence

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

11UCB-J PET Scan

About this trial

This is an interventional diagnostic trial for Opiate Dependence

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CT Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Opiate Use Disorder (OUD)

Cocaine Use Disorder (CUD)

Healthy Controls (HC)

Arm Description

30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan.

30 subjects meeting cocaine dependence criteria 11UCB-J PET Scan.

30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan.

Outcomes

Primary Outcome Measures

11C-UCB-J PET synaptic density

PET scan

Secondary Outcome Measures

Full Information

NCT ID

NCT03527485

First Posted

April 19, 2018

Last Updated

February 14, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03527485

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opiate Dependence, Cocaine Dependence

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Opiate Use Disorder (OUD)

Arm Type

Other

Arm Description

30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan.

Arm Title

Cocaine Use Disorder (CUD)

Arm Type

Other

Arm Description

30 subjects meeting cocaine dependence criteria 11UCB-J PET Scan.

Arm Title

Healthy Controls (HC)

Arm Type

Other

Arm Description

30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan.

Intervention Type

Diagnostic Test

Intervention Name(s)

11UCB-J PET Scan

Intervention Description

11UCB-J PET Scan

Primary Outcome Measure Information:

Title

11C-UCB-J PET synaptic density

Description

PET scan

Time Frame

90 minute scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcella Mignosa, MD

Phone

(203) 974-7253

marcella.mignosa@yale.edu

Facility Information:

Facility Name

CT Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Costeines, MSW

Phone

203-974-7559

jessica.costeines@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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