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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT010125 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).
The investigators will conduct a RCT comparing Mindful Recovery Opioid Care Continuum (M-ROCC), a 24-week motivationally-responsive, trauma-sensitive, Group-Based Opioid Treatment (GBOT) program to a live-online control group, on the number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).
Clinical secondary outcomes include level of anxiety measured by the Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF), level of pain interference measured by the PROMIS Pain Interference Scale (PROMIS-PISF), and the number of positive oral fluid tests for BZD or cocaine during the final 12 weeks of the study. Other exploratory outcomes will be level of anxiety measured by the Beck anxiety inventory (BAI), 24-week intervention retention, as well as mechanisms of self-regulation assessed by self-report and behavioral measures (emotion regulation, decentering/metacognitive monitoring, interoception, experiential avoidance, self-critical rumination, and self-compassion) and their mediating effects on anxiety and opioid abstinence. Qualitative interviews will be conducted with a minimum of 12 and a maximum of 25 M-ROCC completers until thematic saturation to examine themes regarding live-online mindfulness delivery and to compare responses with our R21 qualitative outcomes from our in-person M-ROCC group model. Computerized Adaptive Testing for Mental Health (CAT-MH) will be used to assess changes in psychiatric co-morbidity. Finally, exploratory outcomes of stigma, mindfulness, perceived stress, pain catastrophizing, interpersonal conflict, and shared identity within group will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live-Online Mindful Recovery OUD Care Continuum | Experimental | Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group. |
|
| Live-Online Control | Active Comparator | A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live-Online M-ROCC | Behavioral |
After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods | 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. | Weeks 13-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Positive Oral-fluid Toxicology Tests for Cocaine. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Substance Craving Scale (SUBCS) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zev Schuman-Olivier, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Health Alliance | Somerville | Massachusetts | 02143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38135210 | Background | Rosansky JA, Howard L, Goodman H, Okst K, Fatkin T, Fredericksen AK, Sokol R, Gardiner P, Parry G, Cook BL, Weiss RD, Schuman-Olivier ZD. Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT. Contemp Clin Trials. 2024 Feb;137:107417. doi: 10.1016/j.cct.2023.107417. Epub 2023 Dec 20. | |
| 34118705 | Background | Fatkin T, Moore SK, Okst K, Creedon TB, Samawi F, Fredericksen AK, Roll D, Oxnard A, Le Cook B, Schuman-Olivier Z. Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. J Subst Abuse Treat. 2021 Nov;130:108415. doi: 10.1016/j.jsat.2021.108415. Epub 2021 Apr 15. |
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The PROMIS-ASF and CAT-MH was administered to participants after enrollment which may have caused participants to be excluded based on high mania or psychosis scores, low PTSD or anxiety scores, or no use in the past 90 days. Of 260 participants enrolled, 196 participants met the inclusion criteria and were randomized to begin the study.
Participants were recruited through Facebook, community partners (e.g., Lynn Community Health, Boston Medical Center, North Shore Community Health), online telemedicine providers (e.g., Bicycle Health, Boulder Care), and QR-code flyers linking an online referral form. Participants were recruited from 16 states including Massachusetts, Florida, Vermont, New Hampshire, Connecticut, New York, Maine, Texas, Rhode Island, California, North Carolina, Illinois, Michigan, Virginia, Alabama, and Arizona.
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| ID | Title | Description |
|---|---|---|
| FG000 | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group. Live-Online M-ROCC: 1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. 2. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 16 weeks with 60 minutes/wk. 3. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for graduates of LDM for 50-60 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness. |
| FG001 | Live-Online Control | A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. Live-Online Control: A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study used an intent-to-treat analysis model. Therefore, all participants that were randomized were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group. Live-Online M-ROCC: 1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. 2. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 16 weeks with 60 minutes/wk. 3. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for graduates of LDM for 50-60 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods | 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. | Using an intent-to-treat, mixed-effects GEE analysis with the covariates baseline buprenorphine dose, cocaine use, and annual income. | Posted | Mean | 95% Confidence Interval | percentage of 2-week time periods | Weeks 13-24 |
|
Adverse event data were collected over the 24 weeks that participants were in the study.
The definitions do not differ. Staff monitored adverse events (AEs) at each study visit and via a REDCap survey at weeks 8, 16, and 24, rated by severity, relatedness, expectedness, with regular DSMB review. All-Cause Mortality was not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group. Live-Online M-ROCC: 1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. 2. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 16 weeks with 60 minutes/wk. 3. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for graduates of LDM for 50-60 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | Pt hospitalized for infection in chin. Not related to study. Pt hospitalized for infection in blood. Needed IV antibiotics. Not related to study. Participant was hospitalized for poison ivy infection. Not related to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickness | Immune system disorders | Non-systematic Assessment | Participants experienced cold symptoms. Not study related. |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zev Schuman-Olivier | Cambridge Health Alliance | 617-591-6056 | zschuman@cha.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2023 | Feb 9, 2024 | Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 5, 2022 | Feb 9, 2024 | ICF_007.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Two arms, live-online M-ROCC and live-online control, which are randomly assigned in a 1:1 ratio at the same time and are implemented in parallel.
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The principal investigator will be masked to arm assignment.
|
| Live-Online Control | Behavioral | A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. |
|
| Weeks 13-24 |
| Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines. | 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. | Weeks 13-24 |
| Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) | 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. | 24 Weeks |
| Pain Interference PROMIS (PROMIS-PISF) | 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. | 24 Weeks |
| 24 Weeks |
| 36470641 | Background | Schuman-Olivier Z, Fatkin T, Creedon TB, Samawi F, Moore SK, Okst K, Fredericksen AK, Oxnard AS, Roll D, Smith L, Cook BL, Weiss RD. Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Am J Addict. 2023 May;32(3):244-253. doi: 10.1111/ajad.13364. Epub 2022 Dec 5. |
| 39836426 | Background | Schuman-Olivier Z, Goodman H, Rosansky J, Fredericksen AK, Barria J, Parry G, Sokol R, Gardiner P, Le Cook B, Weiss RD. Mindfulness Training vs Recovery Support for Opioid Use, Craving, and Anxiety During Buprenorphine Treatment: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454950. doi: 10.1001/jamanetworkopen.2024.54950. |
| BG001 | Live-Online Control | A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. Live-Online Control: A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education (years) | Mean | Standard Deviation | years |
|
| Sexual Identity | Count of Participants | Participants |
|
| Annual Income | Count of Participants | Participants |
|
| Buprenorphine Dose | Mean | Standard Deviation | milligrams |
|
| Opioid Craving Scale | Scale Range 0-30, higher rating meant greater craving and vice versa. | Mean | Standard Deviation | units on a scale |
|
| Unemployment Status | Count of Participants | Participants |
|
| Participants with 4+ Adverse Childhood Events (ACES) | Count of Participants | Participants |
|
| Patient-Reported · Outcomes Measurement Information System (PROMIS)-Anxiety T-Score | The mean of the T score is 50 with a standard deviation of 10. Higher scores represent greater anxiety and vice versa. This study determined a T score of 55 to indicate elevated anxiety. | Mean | Standard Deviation | T-score |
|
| Patient-Reported · Outcomes Measurement Information System (PROMIS)-Pain Interference T-Score | The mean of the T score is 50 with a standard deviation of 10. Higher scores represent greater pain interference and vice versa. This study determined a T score of 55 to indicate elevated pain interference. | Mean | Standard Deviation | T-score |
|
| Lifetime heroin use | Count of Participants | Participants |
|
| Lifetime cocaine or crack use | Count of Participants | Participants |
|
| Used fentanyl in 90 days before screening | Count of Participants | Participants |
|
| Past mindfulness experience | Count of Participants | Participants |
|
| Region of the US | Count of Participants | Participants |
|
| OG001 | Live-Online Control | A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. Live-Online Control: A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. |
|
|
| Secondary | Number of Positive Oral-fluid Toxicology Tests for Cocaine. | 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. | We used an intent-to-treat approach, mixed-effects GEE analysis with the covariates baseline buprenorphine dose, cocaine use, and annual income. | Posted | Mean | 95% Confidence Interval | percentage of 2-week time periods | Weeks 13-24 |
|
|
|
| Secondary | Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines. | 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. | We used an intent-to-treat approach, mixed-effects GEE analysis with the covariates baseline buprenorphine dose, cocaine use, and annual income. | Posted | Mean | 95% Confidence Interval | percentage of 2-week time periods | Weeks 13-24 |
|
|
|
| Secondary | Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) | 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. | 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. | Posted | Mean | 95% Confidence Interval | differences in scores on a scale | 24 Weeks |
|
|
|
| Secondary | Pain Interference PROMIS (PROMIS-PISF) | 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. | 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. | Posted | Mean | 95% Confidence Interval | differences in scores on a scale | 24 Weeks |
|
|
|
| Other Pre-specified | Substance Craving Scale (SUBCS) | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 24 Weeks |
|
|
|
| 0 |
| 0 |
| 7 |
| 98 |
| 29 |
| 98 |
| EG001 | Live-Online Control | A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. Live-Online Control: A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness. | 0 | 0 | 2 | 98 | 21 | 98 |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Lung issues related to pneumonia. Not related to the study. |
|
| Heart and Lung Problems | Cardiac disorders | Non-systematic Assessment | Heart and lung problems. Patient was hospitalized for a couple of days. Not related to the study. |
|
| Overdose | Psychiatric disorders | Non-systematic Assessment | Vomited and swallowed vomit while sleeping due to overconsumption of CBD gummies. Not study related. Was hospitalized for a few days. |
|
| Covid-19 | Immune system disorders | Non-systematic Assessment | Participant was hospitalized due to Covid-19 symptoms. Not study related. |
|
| Surgery | Surgical and medical procedures | Non-systematic Assessment | Participant had to have emergency surgery to remove their gallbladder after feeling pain. Not study related. |
|
| Miscarriage | Reproductive system and breast disorders | Non-systematic Assessment | Participant had a miscarriage that required surgery. Not related to the study. |
|
|
| Developed a new condition | General disorders | Non-systematic Assessment | Participants developed new conditions. Not study related |
|
| Worsening Psychiatric Symptoms/Stress | Psychiatric disorders | Non-systematic Assessment | Participants experienced an increase in anxiety, depression, and/or stress. Not study related |
|
| Pain | General disorders | Non-systematic Assessment | Participants experienced increases in pain symptoms. Not study related. |
|
| Stomach Issues | Gastrointestinal disorders | Non-systematic Assessment | Participants experienced stomach pain or gastrointestinal issues. Not study related |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Participants experienced injuries. Not study related. |
|
| Headaches | Nervous system disorders | Non-systematic Assessment | Participants experienced headache symptoms. Not study related. |
|
| Cardiac Issues | Cardiac disorders | Non-systematic Assessment | Participant experienced heart issues. Not study related. |
|
| Kidney stones | Renal and urinary disorders | Non-systematic Assessment | Participants experienced kidney stones. Not study related. |
|
| Pain | General disorders | Non-systematic Assessment | Participant experienced pain during a mindfulness practice. This was related to the study. |
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| Relapse | Psychiatric disorders | Non-systematic Assessment | Participant experienced a relapse in their drinking. Not study related. |
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| Pregnancy | Reproductive system and breast disorders | Non-systematic Assessment | Participants experienced symptoms related to their pregnancies. Not study related. |
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