Longitudinal Assessment of Functional Connectivity in Treatment Engaged Cocaine Users
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| ClinicalTrials.gov Identifier: NCT03554928 |
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Recruitment Status :
Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
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High-relapse rates to addiction are likely due to motivational (limbic) and cognitive (executive) factors. The purpose of this proposal is to determine the relationship between functional connectivity in executive control regions (namely the dorsolateral prefrontal cortex) and both proximal and extended outcomes in treatment seeking cocaine and opiate users. This longitudinal neuroimaging study will assess the integrity of executive and limbic circuits 4 timepoints before and after a 28-day intensive outpatient treatment program. Controls will also be recruited as a comparison group. The fundamental neuroscience knowledge gained from this proposal will be used to develop new evidence-based brain stimulation treatment strategies to enhance the integrity of these circuits and subsequent outcomes in traditional treatment programs.
The purpose of this study is not only to look at the integrity of these circuits in individuals entering treatment but also to see how these circuits change after treatment and if this can be used to predict outcomes. From the larger societal perspective this research may help us determine which individuals are likely going to benefit the most from treatment and perhaps those that are at a greater risk for relapse.
| Condition or disease | Intervention/treatment |
|---|---|
| Cocaine Dependence Substance Use Disorders | Diagnostic Test: magnetic resonance imaging |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 81 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Longitudinal Assessment of Functional Connectivity in Treatment Engaged Cocaine Users |
| Actual Study Start Date : | August 1, 2015 |
| Estimated Primary Completion Date : | April 1, 2019 |
| Estimated Study Completion Date : | July 1, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cocaine Dependent
Individuals with cocaine dependence
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Diagnostic Test: magnetic resonance imaging
Participants will receive a 60 minute magnetic resonance imaging assessment |
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Not Cocaine Dependent
Individuals without cocaine dependence
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Diagnostic Test: magnetic resonance imaging
Participants will receive a 60 minute magnetic resonance imaging assessment |
- Percent change of Blood oxygen level dependent (BOLD) signal in executive compared to limbic brain regions [ Time Frame: This will happen at the baseline MRI scan (Day 1), the 2nd MRI scan (1 month after Day 1), the 3rd MRI scan (2 months after Day 1), the 4th MRI scan (3 months after Day 1) ]Blood oxygen level dependent signal will be measured in several areas of the brain
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| Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Currently enrolled in an intensive outpatient treatment program for cocaine dependence
Exclusion Criteria:
- metal in the body below the neck
- history of traumatic brain injury
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554928
| Contact: Colleen A Hanlon, PhD | 843-792-5732 | hanlon@musc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Colleen A Hanlon, PhD 843-792-5732 hanlon@musc.edu | |
| Principal Investigator: | Colleen A Hanlon, PhD | Medical University of South Carolina |
| Responsible Party: | Colleen A Hanlon, PhD, Associate Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT03554928 History of Changes |
| Other Study ID Numbers: |
33406 |
| First Posted: | June 13, 2018 Key Record Dates |
| Last Update Posted: | June 13, 2018 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Deidentified data will be shared on the NIH neuroimaging biorepository at the conclusion of data analysis |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Analytic Code |
| Time Frame: | These data will be shared within 6 months of the final enrollment and data analysis. |
| Access Criteria: | Access is open to the public |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |