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1H MRS for Cocaine Dependence

Phase 1

Waitlist Available

Led By Gustavo Angarita, MD

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 4 weeks

Awards & highlights

Study Summary

This trial will study how different parts of the brain use glucose and how that affects neurotransmission and synaptic density.

Eligible Conditions

Cocaine Dependence
Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GLU and GLU/GLN ratios

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: [18F]-FDG PET scanExperimental Treatment1 Intervention

All subjects will undergo [18F]FDG PET to establish previously demonstrated reductions in glucose utilization in PFC and assess VS/nucleus accumbent metabolism at baseline.

Group II: [11C]APP311 PET scanExperimental Treatment1 Intervention

All subjects will undergo [11C]APP311 PET imaging to investigate whether there are differences in synaptic integrity / neuronal plasticity in the brains of individuals abstinent from cocaine compared to healthy controls at baseline.

Group III: 1H MRSExperimental Treatment1 Intervention

All subjects will undergo three magnetic resonance spectroscopy (1H-MRS) scans, including before and after two-weeks of placebo and NAC administration.

Group IV: Medication (NAC & placebo) administrationActive Control1 Intervention

Upon completion of baseline (abstinence) 1H-MRS scanning at 7T, CU and HC subjects will participate in two additional 1H-MRS scans, including after 2 weeks of placebo and 2 weeks of NAC administration (3600 mg/day) given in double-blind, randomized, counterbalanced order.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]FDG PET scan

2014

Completed Phase 1

~10

1H MRS

2014

Completed Phase 1

~10

[11C]APP311 PET scan

2014

Completed Phase 1

~10

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,207 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,343 Total Patients Enrolled

Gustavo Angarita, MDPrincipal InvestigatorYale University

Frequently Asked Questions

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

Does the research permit study participants who are over 30 years of age?

"The parameters for this medical investigation require that participants are between 18 and 55 years old. Additionally, there is a total of 56 trials designed to help those under the age of consent as well as 398 studies available for seniors over 65."

Answered by AI

How many volunteers are involved in this clinical trial?

"This trial has ceased patient recruitment, with the initial post on February 1st 2014 and last update occurring on May 20th 2022. If searching for other clinical trials, 858 are currently seeking out individuals with cocaine abuse issues while 24 studies specifically require subjects experienced in 1H MRS."

Answered by AI

Is the enrollment period of this research endeavor still open?

"At present, this investigation is not accepting new participants. This trial was published on February 1st 2014 with its last update being May 20th 2022. If you are interested in alternative studies, there currently exist 858 trials looking for people struggling with cocaine addiction and 24 studies requiring patients for a one hour magnetic resonance spectroscopy (1H MRS)."

Answered by AI

Is 1H MRS a reliable procedure with minimal risks?

"As this is a Phase 1 trial, which has limited data regarding efficacy and safety, our team at Power gave the safety of 1H MRS a score of 1."

Answered by AI

Who fulfills the criteria to enter this medical study?

"Patients must demonstrate a history of cocaine abuse and be aged between 18-55 in order to qualify for this trial. The research group is seeking around 60 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS

2014. "Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02124941.