Longitudinal Assessment of Functional Connectivity in Treatment Engaged Cocaine Users

NCT03554928 | Completed

• 1 other identifier: 33406
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Percent change of Blood oxygen level dependent (BOLD) signal in executive compared to limbic brain regions

  Blood oxygen level dependent signal will be measured in several areas of the brain

  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)

Study Arms (2)

Cocaine Dependent

Individuals with cocaine dependence

Diagnostic Test: magnetic resonance imaging

Not Cocaine Dependent

Individuals without cocaine dependence

Diagnostic Test: magnetic resonance imaging

Interventions

magnetic resonance imaging DIAGNOSTIC_TEST

Participants will receive a 60 minute magnetic resonance imaging assessment

Cocaine Dependent; Not Cocaine Dependent

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Currently enrolled in an intensive outpatient treatment program for cocaine dependence

You may not qualify if:

• metal in the body below the neck
• history of traumatic brain injury

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: June 13, 2018
• Study Start: August 1, 2015
• Primary Completion: June 9, 2019
• Study Completion: June 9, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

US (1)