Clinical trial NCT04278586: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
Official title: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Stress Related Disorder
Anxiety
Depression
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-02-20
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participant lives in Massachusetts, Connecticut, Florida, Maine, New Hampshire, New York, Rhode Island, Texas, or Vermont.
* Diagnosis of opioid use disorder prescribed a stable dose of buprenorphine (at least 4 weeks)
* Less than 90 days of abstinence (from non-prescribed opioids or benzodiazepines, cocaine, or alcohol) OR OUD with a co-morbid anxiety or stress disorder (as evaluated by Computerized Adaptive Testing for Mental Health \[CAT-MH\] or PROMIS-ASF \> 55).
* Able to use an electronic device with a videocamera to attend study groups and complete questionnaires.
* Sufficient English fluency to understand procedures and questionnaires
* Ability to provide informed consent.

Exclusion Criteria:

* Active psychosis
* Bipolar I disorder history or severe level of mania on CAT-MH (\>71)
* Acute suicidality or self-injurious behavior or severe level of suicidality on CAT-SS (\>71)
* Cognitive inability as demonstrated by both the inability to complete an informed consent assessment AND complete the Montreal Cognitive Assessment Blind (MOCA BLIND) \<24 on two different days
* Current participation in another experimental research study
* Previous participation in an 8-week intensive Mindfulness-Based Intervention in past 3 years or participation in the MINDFUL-OBOT pilot study
* Expected medical hospitalization in next 6 months
* Expected incarceration in next 6 months
* Substance use severity requiring likely inpatient treatment in opinion of principal investigator (e.g., severe alcohol withdrawal symptoms, severe benzodiazepine withdrawal symptoms, etc.).
* Inability to participate in group intervention without disrupting group in opinion of principal investigator or site PI.

Primary outcomes:
measure: Number of biochemically-confirmed opioid abstinent 2-week time periods
timeFrame: Weeks 13-24
Secondary outcomes:
measure: Number of positive oral-fluid toxicology tests for Cocaine.
timeFrame: Weeks 13-24
measure: Number of positive oral-fluid toxicology tests for Benzodiazepines.
timeFrame: Weeks 13-24
measure: Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)
timeFrame: 24 Weeks
measure: Pain Interference PROMIS (PROMIS-PISF)
timeFrame: 24 Weeks
Other outcomes:
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 24 Weeks
measure: Substance Craving Scale (SUBCS)
timeFrame: 24 Weeks
measure: Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews
timeFrame: 24 Weeks
measure: Treatment Retention at 24 Weeks
timeFrame: 24 Weeks
measure: Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: 24 Weeks
measure: Self-Compassion Scale (SCS)
timeFrame: 24 Weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: 24 Weeks
measure: Experiences Questionnaire Decentering Subscale (EQD)
timeFrame: 24 Weeks
measure: Self-Critical Rumination Scale (SCRS)
timeFrame: 24 Weeks
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: 24 Weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 24 Weeks
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
timeFrame: 24 Weeks
measure: Interpersonal Mindfulness Scale (IMS)
timeFrame: 24 Weeks
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 24 Weeks
measure: M-ROCC Qualitative Interviews
timeFrame: 24 Weeks
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Study Principal Investigator
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.