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Brain Functional Connectivity in Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT02877849
Recruitment Status : Active, not recruiting
First Posted : August 24, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
Due to the relapsing nature of alcoholism, excessive alcohol consumption represents a significant cost to US society ($249 billion in 20101). About 64% of those entering treatment will relapse within one year. New interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Using resting functional magnetic resonance imaging (fMRI) we have identified brain biomarkers that support long-term abstinence and brain biomarkers that predict relapse. Our data point to specific brain biomarkers that index higher relapse vulnerability at 11 weeks of abstinence. Many individuals, however, have already relapsed by this time. It is unknown whether these biomarkers can be identified earlier during the recovery period. We need to investigate whether this biomarker of relapse vulnerability can be identified during earlier stages of abstinence. Earlier identification of this biomarker will give valuable information for timely targeted interventions (e.g. closer monitoring, longer stay in treatment program, neuromodulation), increasing the chances of maintaining abstinence. The overall objective of this study is to identify biomarkers of relapse during early abstinence (2-3 weeks of abstinence). A secondary objective is to evaluate whether non-imaging measures such as craving6 and executive function7 add value to prediction models. Findings from this proposal will provide insight into the neurobiology of relapse vulnerability that will inform new treatment strategies needed to improve treatment outcome.

Condition or disease Intervention/treatment
Alcohol Use Disorder Device: MRI: Brain Imaging data collection

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Brain Functional Connectivity During Early Recovery in Alcohol Use Disorder as a Marker for Relapse
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Individuals with Alcohol Use Disorder
Individuals with Alcohol Use Disorder will be recruited from Lodging Plus treatment program (Fairview Riverside Hospital, Minneapolis, MN). All patients will have between 2-3 weeks of abstinence from alcohol use. We will collect brain imaging data, this is an observational study.
Device: MRI: Brain Imaging data collection
This study has no intervention, it is observational. We will collect brain imaging data and behavioral assessments.

Healthy Volunteers
Healthy volunteers with comparable age and gender to the patient group will be recruited through community advertisements. We will collect brain imaging data, this is an observational study.
Device: MRI: Brain Imaging data collection
This study has no intervention, it is observational. We will collect brain imaging data and behavioral assessments.




Primary Outcome Measures :
  1. Brain connectivity measures at baseline [ Time Frame: 2 years ]
    Brain imaging data will be collected using a 3T MRI scanner from both groups


Secondary Outcome Measures :
  1. Follow-up abstinence status [ Time Frame: 6 months after baseline assessments ]
    Subjects will be called back for follow-up brain imaging data collection, Timeline Follow-back to measure alcohol use, and relapse (abstinence vs relapse) status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals with alcohol use disorder will be only recruited from the Lodging Plus treatment program at Fairview Riverside in Minneapolis, MN Healthy volunteers will be recruited through community advertisements in Minneapolis, MN
Criteria

Alcohol Use Disorder

INCLUSION CRITERIA:

  • Age 18-60
  • Ability to provide written consent and comply with study procedures
  • Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for Alcohol Use Disorder
  • May have current comorbid drug use, but primary substance use disorder diagnosis needs to be based on alcohol use
  • Must be enrolled in Lodging Plus (Fairview Riverside) treatment program
  • Must have the intention to remain in program until the end of the study

EXCLUSION CRITERIA:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
  • Any MRI scanning contraindications (i.e., metal implants, pacemakers, etc.)
  • DSM-V criteria for psychiatric disorder, may have a lifetime but not current diagnosis of depression
  • Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
  • Clinical evidence for Wernicke-Korsakoff syndrome

Healthy controls

INCLUSION CRITERIA:

  • Age 18-60
  • Ability 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>30 min, HIV)
  • Any MRI scanning contraindications (i.e., metal implants, pacemakers, etc.)
  • DSM-V criteria for psychiatric disorder, may have a lifetime but not current diagnosis of depression
  • Primary current substance use disorder diagnosis on any substance such as alcohol, stimulant, opioids, etc. except for caffeine or nicotine

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): NCT02877849


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
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: NCT02877849     History of Changes
Other Study ID Numbers: 1606M89781
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As requested

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
fMRI
brain networks
biomarker
relapse
alcohol
Additional relevant MeSH terms:
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Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs