- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02028273
Hippocampal Neurogenesis in Human Subjects (NG)
September 6, 2019 updated by: University of Texas Southwestern Medical Center
Hippocampal Neurogenesis in Human Subjects (Pilot Study)
This study is being done to measure the number of brain cells that grow in the brain throughout our lives while determining an effective way to complete this with an MRI (Magnetic Resonance Imaging) scanner.
The number of these brain cells may be affected by cocaine use.
Researchers are trying to understand the long-term effects of cocaine use on the brain.
Study Overview
Status
Completed
Detailed Description
New neurons are generated through the process of neurogenesis.
Although most active during pre-natal development, neurogenesis persists throughout the human lifespan.
In adulthood, neurogenesis occurs predominantly in the subgranular zone of the hippocampal dentate gyrus.
A highly novel methodology using Magnetic Resonance Spectroscopy (MRS) has recently been developed to measure the formation of hippocampal newborn stem cells in the human brain.
We propose to assess Neural Progenitor Cells (NPCs) in the neuropsychiatric disorder cocaine dependence, a chronic disease process associated with pathology of the hippocampus and impaired neurogenesis.
In addition, we will assess other measures associated with neurogenesis, including hippocampal (dentate gyrus) cerebral blood volume (CBV) using Vascular-Space-Occupancy (VASO) Magnetic Resonance Imaging.
We predict that newborn hippocampal cells [or neuronal progenitor cells (NPCs] will be attenuated in recently using cocaine-addicted participants relative to abstinent and control participants, and that these changes will be paralleled by changes in CBV.
In this pilot study, we will assess for these changes in cocaine-addicted subjects who are actively using cocaine and those who are recently abstinent (three to six months) as well as age-, race-, and gender-similar control participants.
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75390-8564
- UT Southwestern Medical Center at Dallas, Division on Addictions
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from residential sober living and outpatient facilities.
Patients will also be recruited through flyers placed locally.
Healthy controls will be recruited from the Greater Dallas community.
Description
Inclusion Criteria:
- Cocaine-dependence (patient population) or no cocaine-dependence (control population)
Exclusion Criteria:
- Other medical or psychiatric disorders that may effect neural functioning
- Medications that may effect neural functioning
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Control
Healthy control group.
No history of substance abuse or dependence.
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Actively using patients
Participants actively using cocaine.
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Abstinent Patients
Participants who have been abstinent from cocaine use for 3-6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assess Neural Progenitor Cells
Time Frame: within 3 weeks of screening physical
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A 1 hour Magnetic Resonance Spectroscopy to determine the presence of newborn hippocampal neurons in using and abstinent cocaine addicts
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within 3 weeks of screening physical
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hippocampal cerebral blood volume
Time Frame: within 3 weeks of screening physical
|
Measure cerebral blood flow during an hour long Vascular-Space-Occupancy (VASO) Magnetic Resonance Imaging to assess production of hippocampal cells
|
within 3 weeks of screening physical
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2012
Primary Completion (ACTUAL)
January 1, 2018
Study Completion (ACTUAL)
January 1, 2018
Study Registration Dates
First Submitted
January 3, 2013
First Submitted That Met QC Criteria
January 3, 2014
First Posted (ESTIMATE)
January 7, 2014
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2019
Last Update Submitted That Met QC Criteria
September 6, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 032012-021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hippocampal Neurogenesis in Cocaine Addiction
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Soterix MedicalIcahn School of Medicine at Mount SinaiCompletedCocaine Use Disorder | Cocaine DependenceUnited States
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Soterix MedicalIcahn School of Medicine at Mount SinaiCompleted
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Seattle Institute for Biomedical and Clinical ResearchAstraZeneca; VA Puget Sound Health Care SystemCompletedSubstance Abuse | Cocaine Dependence | Drug Abuse | Cocaine Abuse | Cocaine AddictionUnited States
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University of Texas Southwestern Medical CenterCompleted
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National Institute on Drug Abuse (NIDA)WithdrawnCocaine Abuse | Cocaine AddictionUnited States
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Catalyst Pharmaceuticals, Inc.National Institute on Drug Abuse (NIDA); VA Office of Research and DevelopmentCompletedCocaine Dependence | Cocaine AddictionUnited States
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Embera NeuroTherapeutics, Inc.CompletedCocaine Dependence | Cocaine AddictionUnited States
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Federal University of Espirito SantoHarvard University; University of GöttingenCompletedExecutive Dysfunction | Cocaine Addiction | Cocaine-related DisorderBrazil
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Assistance Publique - Hôpitaux de ParisMission Interministérielle de Lutte contre la Drogue et la ToxicomanieCompletedCocaine Dependence | Cocaine AddictionFrance
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Hospital de Clinicas de Porto AlegreSecretaria Nacional de Políticas sobre Drogas (SENAD)UnknownAlcohol Addiction | Cocaine AddictionBrazil