Alcohol, Inflammation, and Mindfulness Study (AIM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02994043|
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Behavioral: Mindfulness Plus Relapse Prevention Therapy Behavioral: Relapse Prevention Therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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)
- Decrease in methylation of key genes involved in Alcohol Use Disorders [ Time Frame: 4, 8, 20, and 32 weeks ]Methylation on immune-linked genes.
- Decrease in inflammation biomarkers [ Time Frame: 4, 8, 20, and 32 weeks ]Inflammatory cytokines.
- Changes in Left and Right Executive Control Network (LECN and RECN) connectivity detected by MRI [ Time Frame: 8 weeks ]Connectivity related to cognitive control.
- Changes in blood-oxygen level dependent (BOLD) activation detected by MR [ Time Frame: 8 weeks ]BOLD related to craving.
- Changes in gut microbiota populations [ Time Frame: 8 Weeks ]Gut microbiota diversity and composition.
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
|Contact: Alexandra Zabelski||AIM.CUStudy@gmail.com|
|Contact: Hollis Karolyfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Boulder||Recruiting|
|Boulder, Colorado, United States, 80301|
|Contact: Suzanne Taborsky-Barba|