Experiences of adults with opioid-treated chronic low back pain during the COVID-19 pandemic: A cross-sectional survey study.

This study aimed to evaluate the impact of the COVID-19 pandemic on adults with opioid-treated chronic low back pain (CLBP), an understudied area. Participants in a "parent" clinical trial of non-pharmacologic treatments for CLBP were invited to complete a one-time survey on the perceived pandemic impact across several CLBP- and opioid therapy-related domains. Participant clinical and other characteristics were derived from the parent study's data. Descriptive statistics and latent class analysis analyzed quantitative data; qualitative thematic analysis was applied to qualitative data. The survey was completed by 480 respondents from June 2020 to August 2021. The majority reported a negative pandemic impact on their life (84.8%), with worsened enjoyment of life (74.6%), mental health (74.4%), pain (53.8%), pain-coping skills (49.7%), and finances (45.3%). One-fifth (19.4%) of respondents noted increased use of prescribed opioids; at the same time, decreased access to medication and overall healthcare was reported by 11.3% and 61.6% of respondents, respectively. Latent class analysis of the COVID-19 survey responses revealed 2 patterns of pandemic-related impact; those with worse pandemic-associated harms (n = 106) had an overall worse health profile compared to those with a lesser pandemic impact. The pandemic substantially affected all domains of relevant health-related outcomes as well as healthcare access, general wellbeing, and financial stability among adults with opioid-treated CLBP. A more nuanced evaluation revealed a heterogeneity of experiences, underscoring the need for both increased overall support for this population and for an individualized approach to mitigate harms induced by pandemic or similar crises.

Risk Factors for Self-Harm Ideation Among Persons Treated With Opioids for Chronic Low Back Pain.

OBJECTIVES: Chronic pain is a significant health concern that adversely affects all aspects of life, including emotional well-being. Opioids are prescribed for the management of refractory, severe chronic pain, although they have been associated with adverse effects, including addiction and overdose. The aim of this study was to examine factors that predict thoughts of self-harm among adults with chronic pain who are prescribed opioids. MATERIALS AND METHODS: Seven hundred sixty-five (N=765) persons with opioid-treated chronic lower back pain completed the Current Opioid Misuse Measure (COMM) and other validated questionnaires as part of a larger study. Response to 1 question from the COMM ("How often have you seriously thought about hurting yourself?") was used to assess suicide risk on a 5-point scale (0=never; 4=very often). RESULTS: Participants were categorized into 3 groups according to their responses to the self-harm question: never (N=628; 82.1%), seldom or sometimes (N=74; 9.7%), and often or very often (N=63; 8.2%). Multivariate adjusted odds ratio (aOR) analyses indicated that reports of alcohol or drug overuse within the past month (aOR=1.41,[95% CI 1.11-1.78]), posttraumatic stress (PTSD; aOR=1.24,[1.07 to 1.44]), pain catastrophizing (aOR=1.03,[1.01 to 1.05]), not loving oneself (aOR=0.99,[.98-1.00]) and poor perceived mental health (aOR=0.94,[.92 to 97]) were most associated with thoughts of self-harm. Importantly, the ideation frequency of self-harm was highest among individuals treated with higher daily doses of opioids. DISCUSSION: These results support the need for continued monitoring of adults treated with opioids for chronic pain, particularly among those on high-dose opioids who present with increased negative affect and concerns of substance misuse.

To be aware, or to accept, that is the question: Differential roles of awareness of automaticity and pain acceptance in opioid misuse.

BACKGROUND: Individuals with chronic low back pain (CLBP) are commonly prescribed long-term opioid therapy (LTOT) for analgesia, placing this population at increased risk for opioid misuse and opioid use disorder. Acceptance of aversive experiences (e.g., chronic pain) and awareness of automatic thoughts and behaviors (i.e., automaticity) are two facets of dispositional mindfulness that may serve as protective mechanisms against opioid misuse risk. Therefore, the aim of the current study was to examine the differential contributions of these constructs to opioid misuse risk among adults with CLBP receiving LTOT. METHODS: Data were obtained from a sample of 770 adults with opioid-treated CLBP. Bivariate correlations and hierarchical linear regression analyses were used to determine whether chronic pain acceptance and awareness of automatic thoughts and behaviors explained a statistically significant portion of variance in opioid misuse risk after accounting for the effects of other relevant confounders. RESULTS: Hierarchical regression results revealed that chronic pain acceptance and awareness of automatic thoughts and behaviors contributed a significant portion in the variance of opioid misuse risk. Awareness of automatic thoughts and behaviors was negatively associated with opioid misuse risk, such that individuals with lower levels of awareness of automaticity were at higher risk of opioid misuse. By contrast, pain acceptance was not associated with opioid misuse. CONCLUSIONS: Findings suggest that awareness of automaticity may buffer against opioid misuse risk. Interventions designed to strengthen awareness of automaticity (e.g., mindfulness-based interventions) might be especially efficacious among this population.

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial.

OBJECTIVE: Chronic low back pain (CLBP) is disabling and costly. Existing therapies have proven suboptimal, with many patients resorting to long-term opioid therapy, which can cause harms. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies can be effective and offer unique skills for safe pain coping. This article describes the protocol for a study evaluating comparative effectiveness of CBT and MBT in adults with opioid-treated CLBP. DESIGN: Pragmatic, multi-center randomized controlled trial (RCT). SETTINGS: Community and outpatient care. PARTICIPANTS: Planned enrollment of 766 adults (383/group) with CLBP treated with long-term opioids (≥3 months; ≥15 mg/day morphine-equivalent dose). INTERVENTIONS: CBT or MBT consisting of eight weekly therapist-led, two-hour group sessions, and home practice (≥30 min/day, 6 days/week) during the 12-month study. MAIN OUTCOME MEASURES: Main outcome measures, collected by self-report at baseline, then three, six, nine and 12 months post-entry, include co-primary measures: pain intensity (Numeric Rating Scale) and function (Oswestry Disability Index), and secondary measures: quality of life (Medical Outcomes Study) and average daily opioid dose (Timeline Followback). Baseline scores of depression, anxiety, and opioid misuse questionnaires will be assessed as potential contributors to the heterogeneity of treatment response. Intention-to-treat, linear mixed-effects analysis will examine treatment effectiveness. Qualitative data will augment the quantitative measures. CONCLUSIONS: This will be the largest RCT comparing CBT and MBT in opioid-treated CLBP. It will provide evidence on the impact of these interventions, informing clinical decisions about optimal therapy for safe, effective care, improving quality of life and decreasing opioid-related harm among adults with refractory CLBP.

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial.

OBJECTIVES: To assess the effects of mindfulness-based relapse prevention for alcohol dependence (MBRP-A) intervention on drinking and related consequences. METHODS: 123 alcohol-dependent adults in early recovery, recruited from outpatient treatment programs, were randomly assigned to MBRP-A (intervention plus usual-care; N = 64) or Control (usual-care-alone; N = 59) group. MBRP-A consisted of eight-weekly sessions and home practice. Outcomes were assessed at baseline, 8 weeks and 26 weeks (18 weeks post-intervention), and compared between groups using repeated measures analysis. RESULTS: Outcome analysis included 112 participants (57 MBRP-A; 55 Control) who provided follow-up data. Participants were 41.0 ±â€¯12.2 years old, 56.2% male, and 91% white. Prior to "quit date," they reported drinking on 59.4 ±â€¯34.8% (averaging 6.1 ±â€¯5.0 drinks/day) and heavy drinking (HD) on 50.4 ±â€¯35.5% of days. Their drinking reduced after the "quit date" (before enrollment) to 0.4 ±â€¯1.7% (HD: 0.1 ±â€¯0.7%) of days. At 26 weeks, the MBRP-A and control groups reported any drinking on 11.5 ±â€¯22.5% and 5.9 ±â€¯11.6% of days and HD on 4.5 ±â€¯9.3% and 3.2 ±â€¯8.7% of days, respectively, without between-group differences (ps ≥ 0.05) in drinking or related consequences during the follow-up period. Three MBRP-A participants reported "relapse," defined as three-consecutive HD days, during the study. Subgroup analysis indicated that greater adherence to session attendance and weekly home practice minutes were associated with improved outcomes. CONCLUSIONS: MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone; a return to drinking and relapse to HD were rare in both groups. However, greater adherence to MBRP-A intervention may improve long-term drinking-related outcomes.

Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience.

BACKGROUND: Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM). However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. OBJECTIVE: To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A) intervention in a 26-week randomized controlled trial. METHODS: 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N = 64) or control (usual care alone; N = 59). Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. RESULTS: Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. CONCLUSIONS: A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

Cost of opioid-treated chronic low back pain: Findings from a pilot randomized controlled trial of mindfulness meditation-based intervention.

OBJECTIVE: Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. DESIGN: Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. SETTING: Outpatient. PARTICIPANTS: Thirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew. INTERVENTION: Eight weekly therapist-led MM sessions and at-home practice. OUTCOME MEASURES: Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups. RESULTS: Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. CONCLUSIONS: Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.

Mindfulness Meditation-Based Intervention Is Feasible, Acceptable, and Safe for Chronic Low Back Pain Requiring Long-Term Daily Opioid Therapy.

OBJECTIVE: Although mindfulness meditation (MM) is increasingly used for chronic pain treatment, limited evidence supports its clinical application for opioid-treated chronic low back pain (CLBP). The goal of this study was to determine feasibility, acceptability, and safety of an MM-based intervention in patients with CLBP requiring daily opioid therapy. DESIGN: 26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone. SETTING: Outpatient. PATIENTS: Adults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer. INTERVENTIONS: Targeted MM-based intervention consisted of eight weekly 2-hour group sessions and home practice (30 minutes/d, 6 days/wk) during the study. "Usual care" for opioid-treated CLBP was provided to participants by their regular clinicians. OUTCOME MEASURES: Feasibility and acceptability of the MM intervention were assessed by adherence to intervention protocol and treatment satisfaction among experimental participants. Safety was evaluated by inquiry about side effects/adverse events and opioid dose among all study participants. RESULTS: Thirty-five participants enrolled during the 10-week recruitment period. The mean age (±standard deviation) was 51.8 ± 9.7 years; the patients were predominantly female, with substantial CLBP-related pain and disability, and treated with 148.3 ± 129.2 mg of MED per day. All participants completed baseline assessments; none missed both follow-up assessments or withdrew. Among experimental participants (n = 21), 19 attended 1 or more intervention sessions and 14 attended 4 or more. They reported, on average, 164.0 ± 122.1 minutes of formal practice per week during the 26-week study and 103.5 ± 111.5 minutes of brief, informal practice per week. Seventeen patients evaluated the intervention, indicating satisfaction; their qualitative responses described the course as useful for pain management (n = 10) and for improving pain coping skills (n = 8). No serious adverse events or safety concerns occurred among the study participants. CONCLUSIONS: MM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP.

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial.

OBJECTIVE: To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). DESIGN: 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). SETTING: Outpatient. SUBJECTS: Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. METHODS: The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). RESULTS: Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen's d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. CONCLUSIONS: Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP.

Pharmacological and toxicological profile of opioid-treated, chronic low back pain patients entering a mindfulness intervention randomized controlled trial.

OBJECTIVE: Refractory chronic low back pain (CLBP) often leads to treatment with long-term opioids. Our goal was to describe the pharmaco-toxicological profile of opioid-treated CLBP patients and identify potential areas for care optimization. DESIGN: Cross-sectional analysis. SETTING: Outpatient primary care. PARTICIPANTS: CLBP patients prescribed ≥ 30 mg/d of morphine-equivalent dose (MED) for ≥3 months. OUTCOME MEASURES: Self-reported clinical, medication (verified) and substance use, and urine drug testing (UDT) data were collected. RESULTS: Participants (N = 35) were 51.8 ± 9.7 years old, 80 percent female with CLBP for 14.2 ± 10.1 years, treated with opioids for 7.9 ± 5.7 years, with severe disability (Oswestry Disability Index score: 66.7 ± 11.4), and average pain score of 5.6 ± 1.5 (0-10 rating scale). Participants reported using tobacco (N = 14), alcohol (N = 9) and illicit drugs or unprescribed medications (N = 10). On average, participants took 13.4 ± 6.8 daily medications, including 4.7 ± 1.8 pain-modulating and 4.7 ± 2.0 sedating medications. Among prescribed opioids, 57.1 percent were long-acting and 91.4 percent were short-acting, with a total of 144.5 ± 127.8 mg/d of MED. Sixteen participants were prescribed benzodiazepines and/or zolpidem/ zaleplon. Fifteen participants had UDT positive for illicit drugs or unprescribed medications; in addition, eight tested positive for alcohol and 19 for cotinine. Compared to those with negative UDTs, those with positive UDTs (N = 15) received lower daily "total" and "extended release" opioid doses, and were more likely to test positive for cotinine (p < 0.05). CONCLUSIONS: Study findings corroborate existing evidence for high medication burden and high likelihood of substance misuse among opioid-treated CLBP patients. Further research is needed to help understand causality and ways to optimize care and clinical outcomes.