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Alcohol, Inflammation, and Mindfulness Study (AIM)

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ClinicalTrials.gov Identifier: NCT02994043
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kent Hutchison, University of Colorado, Boulder

Brief Summary:
The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders (AUD) by implementing an 8-week long intervention and examining neurobiological, immunological, and epigenetic characteristics of AUD.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Mindfulness Plus Relapse Prevention Therapy Behavioral: Relapse Prevention Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dismantling MBRP: Identifying Critical Neuroimmune Mechanisms of Action.
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MBRP Behavioral: Mindfulness Plus Relapse Prevention Therapy
An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.

Active Comparator: RP Behavioral: Relapse Prevention Therapy
An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.




Primary Outcome Measures :
  1. Reduction of heavy drinking days [ Time Frame: 4, 8, 20, and 32 weeks ]
    Timeline Follow-back measure of heavy drinking days in the last month (4+ for women, 5+ for men)

  2. Decrease in methylation of key genes involved in Alcohol Use Disorders [ Time Frame: 4, 8, 20, and 32 weeks ]
    Methylation on immune-linked genes.

  3. Decrease in inflammation biomarkers [ Time Frame: 4, 8, 20, and 32 weeks ]
    Inflammatory cytokines.

  4. Changes in Left and Right Executive Control Network (LECN and RECN) connectivity detected by MRI [ Time Frame: 8 weeks ]
    Connectivity related to cognitive control.

  5. Changes in blood-oxygen level dependent (BOLD) activation detected by MR [ Time Frame: 8 weeks ]
    BOLD related to craving.


Secondary Outcome Measures :
  1. Changes in gut microbiota populations [ Time Frame: 8 Weeks ]
    Gut microbiota diversity and composition.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Have a primary Diagnostic Statistical Manual-V (DSM-V) diagnosis of alcohol use disorder;
  2. Must be within 10 days of last drink;
  3. Must have been drinking heavily (criteria dependent upon individual?s age, gender, and BMI) for a consistent period of time;
  4. Must have a breath alcohol level of 0 at screening;
  5. Must have a Clinical Institute Withdrawal Assessment (CIWA) score less than 8 (indicating no need for medical detox);
  6. Must have expressed a desire during their initial screen to reduce the number of drinks they regularly consume

Exclusion Criteria:

  1. Currently taking any medications for the treatment of psychiatric disorders, including substance use disorders, mood disorders, and psychosis;
  2. Pregnant, as indicated by a pregnancy test which will be administered at baseline;
  3. Positive for, sedatives, opiates, cocaine, or amphetamine on drug screen at baseline;
  4. Meets criteria for psychotic disorder, bipolar disorder, or a major depressive episode

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): NCT02994043


Contacts
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Contact: Alexandra Zabelski AIM.CUStudy@gmail.com
Contact: Hollis Karoly hollis.karoly@colorado.edu

Locations
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United States, Colorado
University of Colorado Boulder Recruiting
Boulder, Colorado, United States, 80301
Contact: Suzanne Taborsky-Barba         
Sponsors and Collaborators
University of Colorado, Boulder

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Responsible Party: Kent Hutchison, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02994043     History of Changes
Other Study ID Numbers: 16-0056
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders