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Psychiatric and Cognitive Testing for Cocaine Dependence

Phase 1
Waitlist Available
Led By Patrick Worhunsky, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2-5 days of self-administration in cocaine participants; within 5 days of pet as possible for healthy comparison participants
Awards & highlights

Study Summary

This trial will investigate how cocaine use changes the brain's chemistry and circuitry, which can make quitting hard and complicate treatment efforts. Current cocaine users who haven't sought treatment will do a cocaine self-administration paradigm, then have PET and fMRI scans.

Eligible Conditions
  • Cocaine Dependence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2-5 days of self-administration in cocaine participants; within 5 days of pet as possible for healthy comparison participants
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2-5 days of self-administration in cocaine participants; within 5 days of pet as possible for healthy comparison participants for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Brain Network Engagement Associated With Response Inhibition
Regional Availability of Metabotropic Glutamate Type-5 Receptors (mGluR5)
Resting-state Functional Brain Network Activity, Fractional Amplitude of Low-frequency Fluctuations (fALFF)
Secondary outcome measures
Brain activity patterns

Trial Design

4Treatment groups
Active Control
Group I: Psychiatric and Cognitive TestingActive Control1 Intervention
All participants will complete psychiatric assessment and cognitive testing.
Group II: Cocaine Self-adminstrationActive Control1 Intervention
This arm plans to assess the subjective (e.g., euphoric) and behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment seeking users of the drug in a human laboratory study of self-regulated cocaine administration.
Group III: Magnetic Resonance ImagingActive Control1 Intervention
All participants will complete one MRI scan to assess brain structure and function.
Group IV: Positron Emission TomographyActive Control1 Intervention
All participants will complete a PET scan to assess mGluR5 receptors using [18-F]FPEB

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,561 Total Patients Enrolled
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,496 Total Patients Enrolled
Patrick Worhunsky, PhDPrincipal Investigator - Assistant Professor
Yale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies within this experimental research project for volunteers?

"Affirmative. According to information available on clinicaltrials.gov, this research endeavour is still recruiting individuals as of today. It was initially posted on February 26th 2018 and last modified on July 25th 2022; it seeks a total of 40 participants from single location."

Answered by AI

Can you provide details on any prior trials that have included psychological and intellectual examinations?

"Currently, there exist two operational studies evaluating the effects of Psychiatric and Cognitive Testing. Both are at a pre-Phase 3 stage with sites in New Haven, Connecticut."

Answered by AI

Does the FDA certify Psychiatric and Cognitive Testing?

"With limited data on safety and efficacy, our team at Power gave Psychiatric and Cognitive Testing a score of 1."

Answered by AI

Is this research opportunity open to senior citizens?

"This trial will accept those of legal age and younger than 55 years old."

Answered by AI

To what extent has participation in this experiment been embraced?

"Affirmative, according to the details posted on clinicaltrials.gov this medical investigation is actively looking for volunteers. It was initially published on February 26th 2018 and has been updated most recently in July 25th 2022. The research team needs to enroll 40 people from a single location."

Answered by AI

What types of participants are ideal for this clinical research?

"The study requires 40 participants aged 18 to 55 who have a history of cocaine abuse. In addition, the individuals must be between 21 and 55 years old, have recently used street-level amounts of cocaine, and consumed it through intravenous or smoked means (e.g., crack/freebase)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Investigation of Cocaine Addiction Using mGluR5 PET and fMRI
Patrick Worhunsky 2018. "Investigation of Cocaine Addiction Using mGluR5 PET and fMRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03471182.
~4 spots leftby Apr 2025
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