Trial Outcomes & Findings for Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase) (NCT NCT04278586)

Last Updated: 2025-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

260 participants

Primary outcome timeframe

Weeks 13-24

Results posted on

2025-07-22

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	98	98
Overall Study COMPLETED	48	68
Overall Study NOT COMPLETED	50	30

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	13	6
Overall Study Lost to Follow-up	37	24

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.	Total n=196 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	95 Participants n=7 Participants	192 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 10.4 • n=5 Participants	40.9 years STANDARD_DEVIATION 10.3 • n=7 Participants	41.0 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	91 Participants n=7 Participants	179 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants	90 Participants n=7 Participants	180 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Marital Status Single	43 Participants n=5 Participants	44 Participants n=7 Participants	87 Participants n=5 Participants
Marital Status Married or Living as Married	29 Participants n=5 Participants	37 Participants n=7 Participants	66 Participants n=5 Participants
Marital Status Divorced	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Marital Status Widowed	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Marital Status Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Education (years)	13.1 years STANDARD_DEVIATION 2.2 • n=5 Participants	13.5 years STANDARD_DEVIATION 2.6 • n=7 Participants	13.3 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sexual Identity Straight or Heterosexual	81 Participants n=5 Participants	78 Participants n=7 Participants	159 Participants n=5 Participants
Sexual Identity Lesbian, Gay, or Homosexual	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sexual Identity Bisexual	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sexual Identity Other	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Annual Income <$20,000	37 Participants n=5 Participants	46 Participants n=7 Participants	83 Participants n=5 Participants
Annual Income $20,000-$80,000	53 Participants n=5 Participants	38 Participants n=7 Participants	91 Participants n=5 Participants
Annual Income >$80,000	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Annual Income Unreported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Buprenorphine Dose	13.3 milligrams STANDARD_DEVIATION 6.3 • n=5 Participants	15.7 milligrams STANDARD_DEVIATION 6.9 • n=7 Participants	14.5 milligrams STANDARD_DEVIATION 6.7 • n=5 Participants
Opioid Craving Scale	3.4 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants	3.0 units on a scale STANDARD_DEVIATION 2.5 • n=7 Participants	3.2 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants
Unemployment Status	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Participants with 4+ Adverse Childhood Events (ACES)	65 Participants n=5 Participants	65 Participants n=7 Participants	130 Participants n=5 Participants
Patient-Reported · Outcomes Measurement Information System (PROMIS)-Anxiety T-Score	64.5 T-score STANDARD_DEVIATION 6.2 • n=5 Participants	65.9 T-score STANDARD_DEVIATION 6.8 • n=7 Participants	65.2 T-score STANDARD_DEVIATION 6.5 • n=5 Participants
Patient-Reported · Outcomes Measurement Information System (PROMIS)-Pain Interference T-Score	60.9 T-score STANDARD_DEVIATION 9.0 • n=5 Participants	59.1 T-score STANDARD_DEVIATION 10.1 • n=7 Participants	60.0 T-score STANDARD_DEVIATION 9.6 • n=5 Participants
Lifetime heroin use	56 Participants n=5 Participants	59 Participants n=7 Participants	115 Participants n=5 Participants
Lifetime cocaine or crack use	78 Participants n=5 Participants	67 Participants n=7 Participants	145 Participants n=5 Participants
Used fentanyl in 90 days before screening	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Past mindfulness experience	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of the US Northeast	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Region of the US South	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Region of the US Midwest	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Region of the US West	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 13-24

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

Outcome measures

Outcome measures
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.
Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods	13.4 percentage of 2-week time periods Interval 6.2 to 20.5	12.7 percentage of 2-week time periods Interval 7.5 to 18.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.
Number of Positive Oral-fluid Toxicology Tests for Cocaine.	8.4 percentage of 2-week time periods Interval 0.0 to 16.6	1.5 percentage of 2-week time periods Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.
Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines.	22.1 percentage of 2-week time periods Interval 12.7 to 31.5	20.2 percentage of 2-week time periods Interval 12.7 to 27.7

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.
Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)	-9.0 differences in scores on a scale Interval -11.7 to -6.3	-10.0 differences in scores on a scale Interval -12.0 to -8.0

SECONDARY outcome

Timeframe: 24 Weeks

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.

Outcome measures

Outcome measures
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.
Pain Interference PROMIS (PROMIS-PISF)	-4.1 differences in scores on a scale Interval -7.3 to -0.9	-4.4 differences in scores on a scale Interval -6.8 to -2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

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.

Outcome measures

Outcome measures
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 Participants 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.	Live-Online Control n=98 Participants 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.
Substance Craving Scale (SUBCS)	-2.3 score on a scale Interval -2.9 to -1.7	-1.3 score on a scale Interval -1.9 to -0.8

Adverse Events

Live-Online Mindful Recovery OUD Care Continuum

Serious events: 7 serious events

Other events: 29 other events

Deaths: 0 deaths

Live-Online Control

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 participants at risk 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.	Live-Online Control n=98 participants at risk 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.
Infections and infestations Infection	3.1% 3/98 • 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.	0.00% 0/98 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.0% 1/98 • 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.	0.00% 0/98 • 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.
Cardiac disorders Heart and Lung Problems	0.00% 0/98 • 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.	1.0% 1/98 • 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.
Psychiatric disorders Overdose	1.0% 1/98 • 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.	0.00% 0/98 • 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.
Immune system disorders Covid-19	1.0% 1/98 • 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.	0.00% 0/98 • 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.
Surgical and medical procedures Surgery	0.00% 0/98 • 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.	1.0% 1/98 • 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.
Reproductive system and breast disorders Miscarriage	1.0% 1/98 • 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.	0.00% 0/98 • 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.

Other adverse events

Other adverse events
Measure	Live-Online Mindful Recovery OUD Care Continuum n=98 participants at risk 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.	Live-Online Control n=98 participants at risk 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.
Immune system disorders Sickness	2.0% 2/98 • 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.	3.1% 3/98 • 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.
General disorders Developed a new condition	5.1% 5/98 • 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.	1.0% 1/98 • 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.
Psychiatric disorders Worsening Psychiatric Symptoms/Stress	7.1% 7/98 • 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.	5.1% 5/98 • 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.
General disorders Pain	1.0% 1/98 • 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.	0.00% 0/98 • 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.
Gastrointestinal disorders Stomach Issues	2.0% 2/98 • 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.	1.0% 1/98 • 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.
Injury, poisoning and procedural complications Injury	3.1% 3/98 • 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.	2.0% 2/98 • 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.
Nervous system disorders Headaches	2.0% 2/98 • 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.	0.00% 0/98 • 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.
Cardiac disorders Cardiac Issues	1.0% 1/98 • 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.	0.00% 0/98 • 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.
Renal and urinary disorders Kidney stones	1.0% 1/98 • 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.	1.0% 1/98 • 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.
Psychiatric disorders Relapse	1.0% 1/98 • 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.	0.00% 0/98 • 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.
Reproductive system and breast disorders Pregnancy	0.00% 0/98 • 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.	3.1% 3/98 • 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.

Additional Information

Dr. Zev Schuman-Olivier

Cambridge Health Alliance

Phone: 617-591-6056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place