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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA054309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are:
Participants will:
Be given access to mobile mindfulness training and encouragement to use it daily for 30 days.
Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual First | Active Comparator | This is a crossover trial. Participants in this study arm will have 30 days of treatment as usual then a 14 day washout and then 30 days of mobile mindfulness training |
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| Mobile Mindfulness First | Experimental | This is a crossover trial. Participants in this arm will have 30 days of mobile mindfulness training first then a 14 day washout and then 30 days of treatment as ususal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Mindfulness Training | Behavioral | Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Access | Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once. | 75 days after enrollment |
| Proportion of Acceptability | Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days. | 75 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Trauma Symptoms | Self-reported changes in trauma symptoms as measured by the Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 between baseline and 180 days after enrollment. Items are summed to provide a total severity score (range 0-80) with higher scores indicating more symptoms of trauma. | 180 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability | Change in high frequency heart rate variability between baseline and 180 days after enrollment. | 180 days after enrollment |
| Change in inflammatory marker high-sensitivity C-reactive protein |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Meadows, M.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40509 | United States |
After the study period, all identifiers will be removed from data and specimen, but the de-identified dataset free of PHI specifiers will be uploaded to a data sharing service.
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Beginning 1 year after publication with no end date
Data will be available in a data sharing repository
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Change in Mindfulness | Self-reported changes in mindfulness between as measured by the Five Factor Mindfulness Questionnaire. The Five Factor Mindfulness Questionnaire (FFMQ). It examines 5 key domains of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Scores range from 39 to 195, with higher scores indicating greater tendency to be mindful. | 180 days after enrollment |
Change in high sensitivity C-reactive protein (hsCRP) between baseline and 180 days after enrollment.
| 180 days after enrollment |
| Change in inflammatory marker interleukin-6 | Change in interleukin-6 (IL6) between baseline and 180 days post-enrollment. | 180 days after enrollment |