PMID- 38061786 OWN - NLM STAT- MEDLINE DCOM- 20240404 LR - 20240411 IS - 2168-6238 (Electronic) IS - 2168-622X (Print) IS - 2168-622X (Linking) VI - 81 IP - 4 DP - 2024 Apr 1 TI - Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial. PG - 338-346 LID - 10.1001/jamapsychiatry.2023.5138 [doi] AB - IMPORTANCE: Methadone treatment (MT) fails to address the emotion dysregulation, pain, and reward processing deficits that often drive opioid use disorder (OUD). New interventions are needed to address these factors. OBJECTIVE: To evaluate the efficacy of MT as usual (usual care) vs telehealth Mindfulness-Oriented Recovery Enhancement (MORE) plus usual care among people with an OUD and pain. DESIGN, SETTING, AND PARTICIPANTS: This study was a randomized clinical trial conducted from August 2020 to June 2022. Participants receiving MT for OUD and experiencing chronic pain were recruited at 5 clinics in New Jersey. INTERVENTIONS: In usual care, participants received MT, including medication and counseling. Participants receiving MORE plus usual care attended 8 weekly, 2-hour telehealth groups that provided training in mindfulness, reappraisal, and savoring in addition to usual care. MAIN OUTCOMES AND MEASURE: Primary outcomes were return to drug use and MT dropout over 16 weeks. Secondary outcomes were days of drug use, methadone adherence, pain, depression, and anxiety. Analyses were based on an intention-to-treat approach. RESULTS: A total of 154 participants (mean [SD] age, 48.5 [11.8] years; 88 female [57%]) were included in the study. Participants receiving MORE plus usual care had significantly less return to drug use (hazard ratio [HR], 0.58; 95% CI, 0.37-0.90; P = .02) and MT dropout (HR, 0.41; 95% CI, 0.18-0.96; P = .04) than those receiving usual care only after adjusting for a priori-specified covariates (eg, methadone dose and recent drug use, at baseline). A total of 44 participants (57.1%) in usual care and 39 participants (50.6%) in MORE plus usual care returned to drug use. A total of 17 participants (22.1%) in usual care and 10 participants (13.0%) in MORE plus usual care dropped out of MT. In zero-inflated models, participants receiving MORE plus usual care had significantly fewer days of any drug use (ratio of means = 0.58; 95% CI, 0.53-0.63; P < .001) than those receiving usual care only through 16 weeks. A significantly greater percentage of participants receiving MORE plus usual care maintained methadone adherence (64 of 67 [95.5%]) at the 16-week follow-up than those receiving usual care only (56 of 67 [83.6%]; chi2 = 4.49; P = .04). MORE reduced depression scores and ecological momentary assessments of pain through the 16-week follow-up to a significantly greater extent than usual care (group x time F2,272 = 3.13; P = .05 and group x time F16,13000 = 6.44; P < .001, respectively). Within the MORE plus usual care group, EMA pain ratings decreased from a mean (SD) of 5.79 (0.29) at baseline to 5.17 (0.30) at week 16; for usual care only, pain decreased from 5.19 (0.28) at baseline to 4.96 (0.29) at week 16. Within the MORE plus usual care group, mean (SD) depression scores were 22.52 (1.32) at baseline and 18.98 (1.38) at 16 weeks. In the usual care-only group, mean (SD) depression scores were 22.65 (1.25) at baseline and 20.03 (1.27) at 16 weeks. Although anxiety scores increased in the usual care-only group and decreased in the MORE group, this difference between groups did not reach significance (group x time unadjusted F2,272 = 2.10; P= .12; Cohen d = .44; adjusted F2,268 = 2.33; P = .09). Within the MORE plus usual care group, mean (SD) anxiety scores were 25.5 (1.60) at baseline and 23.45 (1.73) at 16 weeks. In the usual care-only group, mean (SD) anxiety scores were 23.27 (1.75) at baseline and 24.07 (1.73) at 16 weeks. CONCLUSIONS AND RELEVANCE: This randomized clinical trial demonstrated that telehealth MORE was a feasible adjunct to MT with significant effects on drug use, pain, depression, treatment retention, and adherence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04491968. FAU - Cooperman, Nina A AU - Cooperman NA AD - Department of Psychiatry, Division of Addiction Psychiatry, Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. FAU - Lu, Shou-En AU - Lu SE AD - Rutgers School of Public Health, Piscataway, New Jersey. FAU - Hanley, Adam W AU - Hanley AW AD - College of Social Work, University of Utah, Salt Lake City. AD - Center on Mindfulness and Integrative Health Intervention Development, University of Utah, Salt Lake City. FAU - Puvananayagam, Thanusha AU - Puvananayagam T AD - Department of Psychiatry, Division of Addiction Psychiatry, Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. FAU - Dooley-Budsock, Patricia AU - Dooley-Budsock P AD - Department of Psychiatry, Division of Addiction Psychiatry, Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. FAU - Kline, Anna AU - Kline A AD - Department of Psychiatry, Division of Addiction Psychiatry, Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. FAU - Garland, Eric L AU - Garland EL AD - College of Social Work, University of Utah, Salt Lake City. AD - Center on Mindfulness and Integrative Health Intervention Development, University of Utah, Salt Lake City. LA - eng SI - ClinicalTrials.gov/NCT04491968 GR - R01 DA056537/DA/NIDA NIH HHS/United States GR - R01 DA057631/DA/NIDA NIH HHS/United States GR - R01 DA058621/DA/NIDA NIH HHS/United States GR - R33 AT010109/AT/NCCIH NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - JAMA Psychiatry JT - JAMA psychiatry JID - 101589550 RN - UC6VBE7V1Z (Methadone) SB - IM EIN - JAMA Psychiatry. 2024 Jan 24;:. PMID: 38265794 MH - Female MH - Humans MH - Middle Aged MH - *Chronic Pain/drug therapy MH - Methadone/therapeutic use MH - *Mindfulness MH - *Opioid-Related Disorders/drug therapy MH - *Telemedicine MH - Male MH - Adult PMC - PMC10704342 COIS- Conflict of Interest Disclosures: Dr Cooperman reported receiving grants from the National Institutes of Health and Arnold Ventures during the conduct of the study. Drs Hanley and Garland reported receiving grants from the National Center for Complementary and Integrative Health and the National Institute on Drug Abuse during the conduct of this study. Dr Garland reported receiving personal fees from training clinicians in mindfulness; being director of the Center on Mindfulness and Integrative Health Intervention Development; receiving honoraria and payment for delivering seminars, lectures, and teaching engagements (related to training clinicians in Mindfulness-Oriented Recovery Enhancement [MORE]), including those sponsored by institutions of higher education, government agencies, academic teaching hospitals, and medical centers; receiving royalties from the sale of books related to MORE; and being a licensor to BehaVR, LLC. No other disclosures were reported. EDAT- 2023/12/08 00:42 MHDA- 2024/04/04 06:44 PMCR- 2024/12/07 CRDT- 2023/12/07 20:33 PHST- 2024/12/07 00:00 [pmc-release] PHST- 2024/04/04 06:44 [medline] PHST- 2023/12/08 00:42 [pubmed] PHST- 2023/12/07 20:33 [entrez] AID - 2812818 [pii] AID - yoi230105 [pii] AID - 10.1001/jamapsychiatry.2023.5138 [doi] PST - ppublish SO - JAMA Psychiatry. 2024 Apr 1;81(4):338-346. doi: 10.1001/jamapsychiatry.2023.5138.