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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02028273
Other study ID # STU 032012-021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date January 2018

Study information

Verified date September 2019
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States UT Southwestern Medical Center at Dallas, Division on Addictions Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess Neural Progenitor Cells A 1 hour Magnetic Resonance Spectroscopy to determine the presence of newborn hippocampal neurons in using and abstinent cocaine addicts within 3 weeks of screening physical
Secondary Hippocampal cerebral blood volume 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