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Longitudinal Assessment of Functional Connectivity in Treatment Engaged Cocaine Users

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ClinicalTrials.gov Identifier: NCT03554928
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Colleen A Hanlon, PhD, Medical University of South Carolina

Brief Summary:

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
Cocaine Dependent
Individuals with cocaine dependence
Diagnostic Test: magnetic resonance imaging
Participants will receive a 60 minute magnetic resonance imaging assessment

Not Cocaine Dependent
Individuals without cocaine dependence
Diagnostic Test: magnetic resonance imaging
Participants will receive a 60 minute magnetic resonance imaging assessment




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Study Population
Individuals enrolled in an intensive outpatient rehabilitation program will be invited to enroll in this observational study.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Colleen A Hanlon, PhD 843-792-5732 hanlon@musc.edu

Locations
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   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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:
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