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Functional Connectivity Changes During Early Recovery as a Marker for Relapse

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ClinicalTrials.gov Identifier: NCT02861820
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Substance Use Disorder Device: MRI: Brain Imaging Data Collection

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Connectivity Changes During Early Recovery as a Marker for Relapse
Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

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.




Primary Outcome Measures :
  1. Brain connectivity [ Time Frame: Change from Baseline, to 2 months ]
    3T MRI scan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult individuals with Substance Use Disorder
Criteria

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.

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): NCT02861820


Contacts
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Contact: Melanie Stimac LNPIBrainStudy@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Melanie Stimac, MA    612-301-2449    LNPIBrainStudy@umn.edu   
Principal Investigator: Kelvin O Lim, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kelvin O Lim, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02861820     History of Changes
Other Study ID Numbers: 1101M95345
1R01DA038984-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As requested

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
fMRI
brain networks
biomarker
relapse
stimulants

Additional relevant MeSH terms:
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Recurrence
Substance-Related Disorders
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders