Hippocampal Neurogenesis in Cocaine AddictionNGNCT02028273
Hippocampal Neurogenesis in Human Subjects
An observational study of Hippocampal Neurogenesis in Cocaine Addiction, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hippocampal Neurogenesis in Cocaine Addiction
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Cocaine-dependence (patient population) or no cocaine-dependence (control population)
Who cannot join
- Other medical or psychiatric disorders that may effect neural functioning
- Medications that may effect neural functioning
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas, Division on Addictions
Dallas, Texas, 75390-8564
About this study
Official title: 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.
Read the 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.
- Keywords
- Neurogenesis, Addiction, Cocaine, MRI, MRS
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy control group. No history of substance abuse or dependence. | |
| Actively using patients | Participants actively using cocaine. | |
| Abstinent Patients | Participants who have been abstinent from cocaine use for 3-6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Neural Progenitor Cells
A 1 hour Magnetic Resonance Spectroscopy to determine the presence of newborn hippocampal neurons in using and abstinent cocaine addicts
Measured: within 3 weeks of screening physical
Secondary outcomes (1)
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
Measured: within 3 weeks of screening physical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hippocampal Neurogenesis in Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryon Adinoff, M.D., Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028273
- Sponsor's protocol ID
- STU 032012-021
- Acronym
- NG
- Status last verified
- Sep 2019
- First submitted
- 3 Jan 2013
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal Neurogenesis in Human Subjects (Pilot Study)
- ClinicalTrials.gov ID
- NCT02028273
- Acronym / sponsor ID
- NG / STU 032012-021
- Keywords
- Neurogenesis, Addiction, Cocaine, MRI, MRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy control group. No history of substance abuse or dependence. |
| Actively using patients | – | –Participants actively using cocaine. |
| Abstinent Patients | – | –Participants who have been abstinent from cocaine use for 3-6 months. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Cocaine-dependence (patient population) or no cocaine-dependence (control population)
Key exclusion criteria (2 listed)
- Other medical or psychiatric disorders that may effect neural functioning
- Medications that may effect neural functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess Neural Progenitor Cells
Time frame: within 3 weeks of screening physical
A 1 hour Magnetic Resonance Spectroscopy to determine the presence of newborn hippocampal neurons in using and abstinent cocaine addicts
1 secondary outcome
Hippocampal cerebral blood volume
Time frame: within 3 weeks of screening physical
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryon Adinoff, M.D. principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hippocampal Neurogenesis in Cocaine Addiction, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Neural Progenitor Cells (time frame: within 3 weeks of screening physical). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.