Sponsor study identifier
observational
82
1 country
1
Study Start
February 9, 2017
Actual (reported)Primary Completion
October 31, 2019
Actual (reported)Study Completion
October 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2016
Actual (reported)August 24, 2016
Actual (reported)February 9, 2017
Actual (reported)October 31, 2019
Actual (reported)October 31, 2019
Actual (reported)Brain connectivity measures at baseline
Brain imaging data will be collected using a 3T MRI scanner from both groups
2 years
Follow-up abstinence status
6 months after baseline assessments
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.
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.
This study has no intervention, it is observational. We will collect brain imaging data and behavioral assessments.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
University of Minnesota
Minneapolis, Minnesota, 55414, United States
82 participants (actual enrollment reported by the registry).
First Submitted
July 15, 2016
First Posted
August 24, 2016
Study Start
February 9, 2017
Actual (reported)INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2019
Actual (reported)Study Completion
October 31, 2019
Actual (reported)Last Updated
November 6, 2019
Record last verified: 2019-11
As requested
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Source: ClinicalTrials.gov.
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