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.

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample.

OBJECTIVE: Mindfulness-Oriented Recovery Enhancement (MORE) is an efficacious intervention to aid recovery from substance use disorder. This study in a pilot sample of individuals in treatment for opioid use disorder (OUD) characterizes longer-term changes after the MORE intervention and immediate effects of a brief MORE guided meditation session. DESIGN: Twelve female participants in residential treatment for OUD completed an 8-week MORE intervention. Participants completed two sessions: one before and one after the 8-week MORE intervention. Each session included an emotional regulation questionnaire outside an MRI scanner first and then a 10-minute guided MORE meditation inside the scanner during which functional magnetic resonance imaging (fMRI) data were collected. Emotional regulation was measured after 8-weeks of MORE intervention. In addition, functional connectivity (i.e. correlated fMRI signal) between regions in a hypothesized affect regulation network was measured during the meditation state to assess change in brain network function due to 8-weeks of MORE. For each 10-min guided meditation, we also assessed their mood and opioid craving. RESULTS: Nine participants completed all measurements. Participants' emotional regulation difficulty significantly decreased after 8-weeks of MORE intervention. Furthermore, after 8-weeks of MORE, there was significantly increased connectivity between left ventromedial prefrontal cortex and left amygdala and between left ventrolateral prefrontal cortex and left nucleus accumbens captured during a meditation state. In both sessions, positive mood significantly increased after 10-min of guided mediation, however opioid craving was not significantly influenced. CONCLUSIONS: This pilot study characterizes potential benefits of 8-week MORE intervention in improving emotional regulation difficulty and brain function. A 10-min guided MORE meditation may immediately improve mood, with potential to reduce acute stress- or cue-provoked craving. These results warrant future studies with larger sample size.

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being.

BACKGROUND: Chronic pain is highly prevalent among people in methadone maintenance treatment (MMT) for opioid use disorder and is known to be an important contributor to treatment discontinuation and opioid relapse. Mindfulness-Oriented Recovery Enhancement (MORE) is one of the few interventions developed and tested as an integrated treatment to simultaneously address both pain and illicit opioid use; however, this study is the first to evaluate MORE as an adjunct to MMT. METHODS: Randomized individuals in MMT (N = 30) received MORE plus methadone TAU (n = 15) or methadone TAU, only (n = 15). Participants in the MORE arm received their MMT, as usual, and attended eight, weekly, two-hour MORE groups at their MMT clinics. Participants in the TAU arm received their MMT, as usual, and group or individual counseling, as required by the clinic. TAU counseling consisted of relapse prevention, cognitive-behavioral therapy, and supportive treatment. TAU participants did not receive any mindfulness-based intervention. Participants completed assessments at baseline, post-treatment (i.e., 8-weeks post-baseline), and follow-up (i.e., 16-weeks post-baseline). RESULTS: Participants in MORE evidenced significantly fewer baseline adjusted days of illicit drug use and significantly lower levels of craving through 16-week follow-up compared to TAU. Also, Participants in MORE reported significantly lower levels of pain, physical and emotional limitations, depression, and anxiety through 16-week follow-up compared to TAU. Conversely, participants in MORE reported significantly higher levels of well-being, vitality, and social functioning through 16-week follow-up compared to TAU. CONCLUSION: MORE could be an effective adjunct to MMT, and larger trials are warranted.

Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial.

BACKGROUND: Methadone maintenance therapy (MMT) is an efficacious form of medication assisted treatment for opioid use disorder (OUD), yet many individuals on MMT relapse. Chronic pain and deficits in positive affective response to natural rewards may result in dysphoria that fuels opioid craving and promotes relapse. As such, behavioral therapies that ameliorate chronic pain and enhance positive affect may serve as useful adjuncts to MMT. This analysis of ecological momentary assessment (EMA) data from a Stage 1 randomized clinical trial examined effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid craving, pain, and positive affective state. METHODS: Participants with OUD and chronic pain (N = 30) were randomized to 8 weeks of MORE or treatment as usual (TAU). Across 8 weeks of treatment, participants completed up to 112 random EMA measures of craving, pain, and affect, as well as event-contingent craving ratings. Multilevel models examined the effects of MORE on craving, pain, and affect, as well as the association between positive affect and craving. RESULTS: EMA showed significantly greater improvements in craving, pain unpleasantness, stress, and positive affect for participants in MORE than for participants in TAU. Participants in MORE reported having nearly 1.3 times greater self-control over craving than those in TAU. Further, positive affect was associated with reduced craving, an association that was significantly stronger among participants in MORE than TAU. CONCLUSION: MORE may be a useful non-pharmacological adjunct among individuals with OUD and chronic pain in MMT.

The Effects of Positive Affect and Episodic Future Thinking on Temporal Discounting and Healthy Food Demand and Choice Among Overweight and Obese Individuals: Protocol for a Pilot 2×2 Factorial Randomized Controlled Study.

BACKGROUND: Unhealthy behaviors (eg, poor food choices) contribute to obesity and numerous negative health outcomes, including multiple types of cancer and cardiovascular and metabolic diseases. To promote healthy food choice, diet interventions should build on the dual-system model to target the regulation and reward mechanisms that guide eating behavior. Episodic future thinking (EFT) has been shown to strengthen regulation mechanisms by reducing unhealthy food choice and temporal discounting (TD), a process of placing greater value on smaller immediate rewards over larger future rewards. However, these interventions do not target the reward mechanisms that could support healthy eating and strengthen the impact of EFT-anchored programs. Increasing positive affect (PosA) related to healthy food choices may target reward mechanisms by enhancing the rewarding effects of healthy eating. An intervention that increases self-regulation regarding unhealthy foods and the reward value of healthy foods will likely have a greater impact on eating behavior compared with interventions focused on either process alone. OBJECTIVE: This study aimed to introduce a protocol that tests the independent and interactive effects of EFT and PosA on TD, food choice, and food demand in overweight and obese adults. METHODS: This protocol describes a factorial, randomized, controlled pilot study that employs a 2 (affective imagery: positive, neutral) by 2 (EFT: yes, no) design in which participants are randomized to 1 of 4 guided imagery intervention arms. In total, 156 eligible participants will complete 2 lab visits separated by 5 days. At visit 1, participants complete surveys; listen to the audio guided imagery intervention; and complete TD, food demand, and food choice tasks. At visit 2, participants complete TD, food demand, and food choice tasks and surveys. Participants complete a daily food frequency questionnaire between visits 1 and 2. Analyses will compare primary outcome measures at baseline, postintervention, and at follow-up across treatment arms. RESULTS: Funding notification was received on April 27, 2017, and the protocol was approved by the institutional review board on October 6, 2017. Feasibility testing of the protocol was conducted from February 21, 2018, to April 18, 2018, among the first 32 participants. As no major protocol changes were required at the end of the feasibility phase, these 32 participants were included in the target sample of 156 participants. Recruitment, therefore, continued immediately after the feasibility phase. When this manuscript was submitted, 84 participants had completed the protocol. CONCLUSIONS: Our research goal is to develop novel, theory-based interventions to promote and improve healthy decision-making and behaviors. The findings will advance decision-making research and have the potential to generate new neuroscience and psychological research to further understand these mechanisms and their interactions. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11704675; http://www.isrctn.com/ISRCTN11704675 (Archived by WebCite at http://www.webcitation.org/760ouOoKG). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12265.

Field Test of a Dialectical Behavior Therapy Skills Training-Based Intervention for Smoking Cessation and Opioid Relapse Prevention in Methadone Treatment.

Objective: Almost all individuals in methadone treatment for opioid dependence smoke cigarettes, and half of people in methadone treatment have an opioid relapse within six months. Dialectical behavior therapy (DBT) skills training has shown promise for addressing substance use and a variety of health behaviors and conditions; however, it has never been evaluated for smoking cessation in any population. The objective of this study was to field test a DBT skills training-based intervention for tobacco dependence and opioid relapse prevention (DBT-Quit) among people in methadone treatment. Methods: We recruited seven individuals in methadone treatment to participate in a field test of DBT-Quit. Participants attended 12 weekly 90-minute DBT skills training groups, focusing on mindfulness, emotion regulation, and distress tolerance skills. Participants received nicotine patches for eight weeks and completed assessments at baseline, 6 weeks (mid-treatment), and 12 weeks (post-treatment). Results: All but one participant (86%, n = 6) attended at least 50% of intervention sessions. Participants were "very" or "mostly" satisfied with the intervention. At 12 weeks, all but one (86%, n = 6) had made a quit attempt, and one (14%) had seven-day point prevalence abstinence. Participants were smoke-free for 24 hours (14%, n = 1), 7 to 14 days (43%, n = 3), and 30 to 59 days (29%, n = 2). Participants smoked significantly fewer cigarettes per day at 6 weeks and 12 weeks as compared to baseline. No participants used illicit drugs. As compared to baseline, at follow-up there were no significant differences in difficulties with emotion regulation, distress tolerance, or mindfulness. Conclusions: A DBT skills training-based intervention for individuals who smoke and have an opioid use disorder is feasible and acceptable in methadone treatment and may help this population prevent drug relapse, attempt to quit smoking, experience smoke-free days, and cut down on their smoking. More research is needed to determine the optimal structure and components of a DBT skills-based intervention for drug relapse prevention and smoking cessation. Further, a randomized controlled trial of DBT-Quit is needed to determine the efficacy of DBT skills training for smoking cessation and drug relapse prevention in this population.