Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial.

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%]; χ2 = 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 × time F2,272 = 3.13; P = .05 and group × 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 × 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.

Opioid overdose in the age of fentanyl: Risk factor differences among subpopulations of overdose survivors.

BACKGROUND: Although fentanyl is the drug most frequently implicated in overdose deaths, the association between overdose risk and attitudes and behaviors surrounding fentanyl in opioid-using communities has remained understudied. Possible subpopulation differences in fentanyl-related overdose risk remain equally unexamined. This paper addresses these gaps by exploring the association between overdose and fentanyl-related attitudes/behaviors in three subpopulations of overdose survivors. METHODS: In this cross-sectional study, we sampled 432 individuals who currently or recently used opioids from New Jersey methadone and acute residential detoxification programs. Using multinomial regression analysis, we compared overdose risk factors, including fentanyl-related attitudes/behaviors, of those who never overdosed with three subgroups of overdose survivors who experienced: 1. recent overdoses occurring after, but not before, fentanyl expansion; 2. past overdoses occurring before, but not after, fentanyl expansion; 3. persistent overdoses occurring before and after fentanyl expansion. RESULTS: Forty percent of respondents had knowingly used fentanyl and 38% deliberately sought overdose-implicated drugs. Respondents with persistent overdoses represented under 10% of the sample but accounted for 44% of all lifetime overdoses (x̅ =8.03 vs. 1.71 for the full sample). This was also the only subgroup for whom PTSD (AOR=3.84; 95%CI=1.45-10.16; p=.01) and fentanyl-seeking (AOR=1.50; 95% CI=1.16-1.94; p=.01) were significant overdose risk factors. Those with recent overdoses engaged in frequent drug combining (AOR=2.28; 95% CI=1.19-6.98; p=.05), which could have led to inadvertent fentanyl use. Those with past overdoses were not at overdose risk from fentanyl-seeking or drug combining and had rates of methadone treatment comparable to rates of those with no overdoses. CONCLUSION: Harm reduction strategies will need to address consumers' evolving drug preferences as fentanyl continues to saturate local drug markets. Targeting comprehensive interventions, including mental health treatment, to the small group of opioid users with longstanding overdose histories may reduce the burden of overdose in opioid-using communities.

"A Blessing and a Curse:" Opioid Users' Perspectives on Naloxone and the Epidemic of Opioid Overdose.

Background: To address the alarming rise in opioid overdose deaths, states have increased public access to the overdose reversal medication, naloxone. While some studies suggest that increased naloxone accessibility reduces opioid overdose deaths, others raise concerns about unintended consequences, such as increases in risky drug use and opioid re-use post-overdose to counter naloxone-induced withdrawal symptoms. Few studies have examined the impact of expanded naloxone access on the attitudes and behaviors of opioid users. Methods: In this qualitative study, we conducted in-depth, semi-structured interviews with 36 English-speaking opioid users 18+ years of age. Informants were recruited from an urban methadone clinic, a needle exchange program and a residential treatment program. The approximately hour-long interviews focused on users' attitudes and behaviors surrounding naloxone, opioid use and overdose. Transcribed audio-recordings of interviews were analyzed using NVivo. Results: Informants were ambivalent about naloxone, widely acknowledging its life-saving benefits while reporting such negative effects as severe withdrawal symptoms and the promotion of riskier drug use. Naloxone-induced withdrawal, coupled with misperceptions about naloxone's pharmacological effects, prompted overdose survivors to rapidly re-use opioids and refuse hospitalization following an overdose reversal. About half the sample believed naloxone led to greater risk-taking by others, such as fentanyl use or use in higher quantities, but did not endorse riskier drug use themselves. Conclusions: The results suggest the need for targeted education about the pharmacological effects of naloxone and better strategies for managing naloxone-induced withdrawal. Future research should focus on the extent to which naloxone is associated with greater opioid risk-taking.