Functional Connectivity Changes During Early Recovery as a Marker for Relapse

January 19, 2022 updated by: University of Minnesota
The study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. More specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery. This study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult individuals with Substance Use Disorder

Description

Inclusion Criteria:

  • At least 18 but no more than 45 years old at the time of consent.
  • Able to provide written consent and comply with study procedures.

Exclusion Criteria:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, HIV).
  • Any contraindications to MRI scanning (i.e. metal implants, pacemakers, etc.).
  • Intellectual developmental disorder as defined in the DSM-V. Participant may have a diagnosis of an Axis I disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable.
  • Actively suicidal.
  • Positive screen for alcohol and/or drugs. Participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again.
  • Evidence for Wernicke-Korsakoff syndrome.
  • Healthy Controls may never have had any form of substance use disorder other than caffeine or nicotine. Nicotine use will be recorded but will not be an exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Substance Use Disorder (SUD)

Participants in the SUD group will:

  • Complete a diagnostic screening interview at baseline.
  • Complete questionnaires and computer tasks at baseline, 1 month and 2 month time points.
  • Complete MRI brain imaging data collection at the baseline, 1 month and 2 month time points.
  • Complete 9 follow-up phone calls to assess for relapse.
Device: MRI: Brain Imaging Data Collection
This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.
Healthy Control (HC)

Participants in the HC group will:

  • Complete a diagnostic screening interview at baseline.
  • Complete questionnaires and computer tasks at baseline and 2 month time points.
  • Complete MRI brain imaging data collection at the baseline and 2 month time points.
Device: MRI: Brain Imaging Data Collection
This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain connectivity
Time Frame: Change from Baseline, to 2 months
3T MRI scan
Change from Baseline, to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kelvin O Lim, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

March 4, 2020

Study Completion (Actual)

January 26, 2021

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYCH-2016-24183
  • 1R01DA038984-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

As requested

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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