Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)

Biochemically-confirmed opioid abstinence, which is defined as the number of two-week periods with a negative oral fluid screen AND no opioid use reported in weekly self report self-report during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.

Time frame: Weeks 13-24

Population: Using an intent-to-treat, mixed-effects GEE analysis with the covariates baseline buprenorphine dose, cocaine use, and annual income.

Biochemically-confirmed benzodiazepine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.

Time frame: Weeks 13-24

Population: We used an intent-to-treat approach, mixed-effects GEE analysis with the covariates baseline buprenorphine dose, cocaine use, and annual income.

Biochemically-confirmed cocaine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.

Time frame: Weeks 13-24

Population: We used an intent-to-treat approach, mixed-effects GEE analysis with the covariates baseline buprenorphine dose, cocaine use, and annual income.

The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five with a total scale range of 7-35. Higher ratings indicate greater pain interference and lower ratings indicate lesser pain interference. This assessment was done at baseline and weeks 8, 16, and 24.

Time frame: 24 Weeks

Population: Difference-in-differences, intent-to-treat, repeated measures analysis using linear mixed effects models with a study week by group interaction term to estimate the relative changes from baseline to week 24.

The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale from 7-35 used to assess patient-reported health status for anxiety. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Higher ratings indicate greater anxiety symptoms while lower ratings indicate less anxiety symptoms. This will be assessed among participants with an anxiety disorder (defined as PROMIS \>55 at baseline) as well at weeks 8, 16, and 24.

Time frame: 24 Weeks

Population: Difference-in-differences, intent-to-treat, repeated measures analysis using linear mixed effects models with a study week by group interaction term to estimate the relative changes from baseline to week 24. We included only those participants with PROMIS-ASF T-scores above 55 at baseline.

The Substance Craving Scale (SUBCS) is a 6-item scale with a range of 0-60. It includes the 3-item validated Opioid Craving Scale (OCS) as the primary measure with a 0-30 scale based on opioids. The SUBCS adds another 3 items based on other non-opioids substances. The OCS assesses participant craving for Opioids (including fentanyl, heroin, methadone, oxycodone or other opioids) and the (SUBCS) includes the OCS plus other substance use (including illicit drugs \[e.g., cocaine, methamphetamine, etc.\], using unprescribed pills or prescribed medications in ways or at doses for which they were not prescribed \[e.g., Klonopin, etc.\], or drinking alcohol). This study uses the 3-items specifically from the Opioid Craving Scale (OCS) as our outcome measure for this study with a range of 0-30 and includes SUBCS as exploratory. Higher ratings on OCS indicate greater opioid craving and lower ratings indicate less opioid craving.

Time frame: 24 Weeks

Population: Difference-in-differences, intent-to-treat, repeated measures analysis using linear mixed effects models with a study week by group interaction term to estimate the relative changes from baseline to week 24.