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Abstract: The aim of this qualitative study, part of CTN-0115 (Developing an Intervention to Address Intersecting Prescription Opioid and Chronic Pain Stigma in Cancer Survivors), was to characterize opioid stigma in cancer remission using the Opioid Stigma Framework as a grounding theoretical framework. Researchers conducted in-depth qualitative interviews with cancer survivors in remission who are currently or were previously prescribed opioids for moderate-to-severe pain related to their cancer diagnosis (n=17) and clinicians who routinely treat chronic cancer-related pain (n=20). Interviews occurred at a single institution from 05/2021-12/2021. The primary focus of this analysis was to describe perceived stigma from a patient perspective, as relayed by either survivors or treating clinicians. Survivors and clinicians perceived externalized stigma in a variety of healthcare settings, sometimes influenced by survivors’ sociodemographic characteristics (e.g., race). Survivors and clinicians also reported stigmatizing behaviors from a variety of personal relationships, including family and community members, which then impacted decisions around prescription opioid use. Finally, survivors and clinicians described a pervasive sense of internalized stigma related to prescription opioid use in survivorship, including shame, embarrassment, and fear of addiction. Survivors and clinicians also reflected on known disparities in pain management, which in turn may have influenced experiences with opioid stigma. This research extends the Opioid Stigma Framework’s concepts — previously described in patients with active cancer — to opioid stigma in cancer survivors. Given the frequency of opioid prescribing across the cancer continuum, it is crucial to develop targeted and tailored interventions to de-stigmatize clinical care and improve safe, effective chronic cancer pain management. Related protocols: CTN-0115

Abstract:

The Centers for Disease Control and Prevention’s 2022 Clinical Practice Guideline for Prescribing Opioids for Pain cautioned that inflexible opioid prescription duration limits may harm patients. Information about the relationship between initial opioid prescription duration and a subsequent refill could inform prescribing policies and practices to optimize patient outcomes. We assessed the association between initial opioid duration and an opioid refill prescription.

Using data drawn from a multi-site prescription opioid registry developed by CTN-0084, conducted a retrospective cohort study of adults =19 years of age in 10 US health systems between 2013 and 2018 from outpatient care with a diagnosis for back pain without radiculopathy, back pain with radiculopathy, neck pain, joint pain, tendonitis/bursitis, mild musculoskeletal pain, severe musculoskeletal pain, urinary calculus, or headache. Generalized additive models were used to estimate the association between opioid days’ supply and a refill prescription.

Overall, 220,797 patients were prescribed opioid analgesics upon an outpatient visit for pain. Nearly a quarter (23.5%) of the cohort received an opioid refill prescription during follow-up. The likelihood of a refill generally increased with initial duration for most pain diagnoses. About 1 to 3 fewer patients would receive a refill within 3 months for every 100 patients initially prescribed 3 vs. 7 days of opioids for most pain diagnoses. The lowest likelihood of refill was for a 1-day supply for all pain diagnoses, except for severe musculoskeletal pain (9 days’ supply) and headache (3-4 days’ supply).

Conclusions: Long-term prescription opioid use increased modestly with initial opioid prescription duration for most but not all pain diagnoses examined.

Related protocols: CTN-0084

Abstract:

Opioid pain management in cancer survivorship is a complex and understudied topic. For this study, part of NIDA Clinical Trials Network protocol CTN-0115, the authors conducted in-depth, qualitative interviews to understand clinician approaches to opioid pain management in chronic cancer pain and to generate ideas for improvement. They used a rigorous, inductive, qualitative, descriptive approach to examine clinician (n = 20) perspectives about opioid pain management in survivorship, including oncologists (n = 5), palliative care clinicians (n = 8), primary care clinicians (n = 5), and pain management specialists (n = 2).

The findings indicated that no consistent medical home exists for chronic pain management in cancer survivors and that there are fundamental differences in how each subspecialty approaches chronic pain management in survivorship (e.g., “Do we think of this as noncancer pain or cancer pain?… This is in this limbo zone—this gray zone—because it’s cancer-related pain, right?”). Simultaneously, clinicians are influenced by their peers’ perceptions of their opioid prescribing decisions, sparking intraprofessional tension when disagreement occurs. In these instances, clinicians described overthinking and doubting their clinical decision-making as well as a sense of judgment, pressure, and/or shame. Finally, clinicians acknowledged a fear of consequences for opioid prescribing decisions. Specifically, participants cited conflict with patients, sometimes escalating to aggression and threats of violence, as well as potential disciplinary actions and/or legal consequences.

Conclusions: Participants suggested that opportunities to improve chronic cancer pain care include developing clear, systematic guidance for chronic cancer pain management, facilitating clinician communication and consultation, creating tailored survivorship care plans in partnership with patients, and developing accessible, evidence-based, complementary pain treatments.

Related protocols: CTN-0115

Abstract:

In response to the opioid crisis in the United States, population-level prescribing of opioids has been decreasing; there are concerns, however, that dose reductions are related to potential adverse events. The purpose of this study was to examine associations between opioid dose reductions and risk of 1-month potential adverse events (emergency department (ED) visits, opioid overdose, benzodiazepine prescription fill, all-cause mortality).

This observational cohort study used electronic health record and claims data from eight United States health systems in a prescription opioid registry (Clinical Trials Network protocol CTN-0084). All opioid fills (excluding buprenorphine) between 1/1/2012 and 12/31/2018 were used to identify baseline periods with mean morphine milligram equivalents daily dose of = 50 during six consecutive months. Researchers identified 60,040 non-cancer patients with = one 2-month dose reduction period (600,234 unique dose reduction periods). Analyses examined associations between dose reduction levels (1-<15%, 15-<30%, 30-<100%, 100% over 2 months) and potential adverse events in the months following a dose reduction using logistic regression analysis, adjusting for patient characteristics.

Overall, dose reduction periods involved mean reductions of 18.7%. Compared to reductions of 1–<15%, dose reductions of 30–<100% were associated with higher odds of ED visits (OR 1.14, 95% CI 1.10, 1.17), opioid overdose (OR 1.41, 95% CI 1.09–1.81), and all-cause mortality (OR 1.39, 95% CI 1.16–1.67), but lower odds of a benzodiazepine fill (OR 0.83, 95% CI 0.81–0.85). Dose reductions of 15–<30%, compared to 1–<15%, were associated with higher odds of ED visits (OR 1.08, 95% CI 1.05–1.11) and lower odds of a benzodiazepine fill (OR 0.93, 95% CI 0.92–0.95), but were not associated with opioid overdose and all-cause mortality.

Conclusions: Greater dose reductions were associated with elevated odds of potential adverse events, relative to smaller dose reductions. Dose reductions for patients on long-term opioid therapy require careful planning and monitoring, particularly soon after a reduction.

Related protocols: CTN-0084

Abstract:

Medical cannabis is commonly used for chronic pain, but little is known about differences in characteristics, cannabis use patterns, and perceived helpfulness among primary care patients who use cannabis for pain versus nonpain reasons.

Among 1688 patients who completed a 2019 cannabis survey administered in a health system in Washington state, where recreational use is legal, participants who used cannabis for pain (n = 375) were compared with those who used cannabis for other reasons (n = 558) using survey and electronic health record data. We described group differences in participant characteristics, use patterns, and perceptions and applied adjusted multinomial logistic and modified Poisson regression.

Participants who used cannabis for pain were significantly more likely to report using applied (50.7% vs 10.6%) and beverage cannabis products (19.2% vs 11.6%), more frequent use (47.1% vs 33.1% for use =2 times per day; 81.6% vs 69.7% for use 4 to 7 days per week), and smoking tobacco cigarettes (19.2% vs 12.2%) than those who used cannabis for other reasons. They were also significantly more likely to perceive cannabis as very/extremely helpful (80.5% vs 72.7%), and significantly less likely to use cannabis for nonmedical reasons (4.8% vs 58.8%) or report cannabis use disorder symptoms (51.7% vs 61.1%).

Conclusions: Primary care patients who use cannabis for pain use it more frequently, often in applied and ingested forms, and have more co-use of tobacco, which may differentially impact safety and effectiveness. These findings suggest the need for different approaches to counseling in clinical care.

Related protocols: CTN-0077-Ot

Abstract:

Opioid use disorder (OUD) is a deadly illness that remains undertreated, despite effective pharmacological treatments. Barriers, such as stigma, treatment affordability, and a lack of training and prescribing within medical practices result in low access to treatment. Software-delivered measurement-based care (MBC) is one way to increase treatment access. MBC uses systematic patient symptom assessments to inform an algorithm to support clinicians at critical decision points.

Focus groups of faculty clinicians (N=33) from 3 clinics were conducted to understand perceptions of OUD diagnosis and treatment and whether a computerized MBC model might assist with diagnosis and treatment. Themes from the transcribed focus groups were identified in two phases: (1) content analysis focused on uncovering general themes; and (2) systematic coding and interpretation of the data.

Analysis revealed six major themes utilized to develop the coding terms: “distinguishing between chronic pain and OUD,” “current practices with patients using prescribed or illicit opioids or other drugs,” “attitudes and mindsets about providing screening or treatment for OUD in your practice,” “perceived resources needed for treating OUD,” “primary care physician role in patient care not specific to OUD,” and “reactions to implementation of proposed clinical decision support tool.”

Conclusions: Results revealed that systemic and attitudinal barriers to screening, diagnosing, and treating OUD continue to persist. Providers tended to view the software-based MBC program favorably, indicating that it may be a solution to increasing accessibility to OUD treatment; however, further interventions to combat stigma would likely be needed prior to implementation of these programs.

Related protocols: CTN-0090

Abstract:

Both patients and clinicians have described discussions of potential opioid risks as challenging. This study, part of CTN-0095, “Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings,” aimed was to understand patient perspectives on discussing opioid risks with primary care clinicians (PCCs).

Patients identified to be at elevated risk for problems with opioids (i.e., opioid use disorder [OUD] diagnosis, taking a medication for OUD, or having = 3 opioid prescriptions in the last year) were recruited from an integrated, Upper Midwest health system to participate in semi-structured qualitative interviews. Interview questions aimed to better understand patient views on conversations about opioid risks with PCCs and perceptions of OUD screening and treatment in primary care. Interviews were analyzed using an inductive thematic analysis approach.

A total of 20 patients participated (mean age: 53.5 years; 65% male). Six themes emerged: 1) archetypes of patient relationships with opioids (long-term opioid use, acute opioid use, OUD in treatment, OUD no treatment) require different approaches in discussing opioid risks; 2) patients may develop their own archetypes about PCCs and opioids; 3) these archetypes may help guide how conversations about opioids are conducted (e.g., PCC demeanor, terminology); 4) most patients believe that primary care is an appropriate setting for opioid risk discussions; 5) patients may have limited awareness of the availability and value of overdose rescue medications; and 6) handouts are more acceptable if perceived to come from the PCC’s assessment instead of a computer.

Conclusions: Results suggest that patients generally perceive discussing opioid risks with PCCs acceptable. PCCs should tailor opioid risk conversations to patients’ specific situations and needs.

Related protocols: CTN-0095

Abstract:

This secondary analysis of data from CTN-0093 (Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool [PHARMSCREEN]) examined relationships between pain severity and interference and substance use among patients filling opioid prescriptions in Indiana and Ohio community pharmacies (n = 1,461). Researchers also sought to explore the moderating role of gender in pain-substance use relations.

The study used patient-reported data from a cross-sectional health survey linked with controlled substance dispensing data from statewide prescription drug monitoring programs. Multivariable logistic regression estimated associations between pain severity and interference and various indices of risky prescription opioid use and non-opioid substance use. Exploratory analyses examined whether gender moderated associations.

Increased pain severity was associated with increased odds of moderate- to high-risk opioid use (OR: 1.23; 95% CI: 1.16-1.31) and opioid-benzodiazepine co-use (OR: 1.20; 95% CI: 1.03-1.40). Increased pain interference was associated with greater odds of receiving opioids from multiple pharmacies or providers (OR: 1.15; 95% CI: 1.01-1.31). Increased pain severity and interference were associated with higher odds of any tobacco use (severity: OR: 1.13; 95% CI: 1.06-1.21; interference: OR: 1.07; 95% CI: 1.01-1.12) and weekly to daily sedative use (severity: OR: 1.13; 95% CI: 1.03-1.25; interference: OR: 1.13; 95% CI: 1.04-1.22). Increased pain severity was associated with decreased odds of any alcohol use (OR: 0.93; 95% CI: 0.88-0.99). Gender was a significant effect modifier in associations between pain and alcohol, tobacco, and cannabis use.

Conclusions: This study suggests that pain severity and interference are associated with increased use of non-medical prescription opioids, sedatives, and tobacco and decreased use of alcohol, in ways that are different between women and men. Findings may guide the development of gender-sensitive evidence-based strategies to ameliorate or prevent substance misuse among patients living with pain.

Related protocols: CTN-0093

Abstract:

Individuals with pain prescribed opioids experience high rates of comorbid depression. The aim of this study was to characterize pain, substance use, and health status as a function of depressive symptom level in individuals filling an opioid prescription at a community pharmacy.

Participants (N=1268) filling an opioid prescription enrolled in a study (CTN-0093) validating a prescription drug monitoring metric completed an online survey assessing sociodemographics, depressive symptoms, substance use, prescription opioid misuse, overdose history, general health, and pain severity and interference.

Approximately one-fifth (19.3%) had a positive depression screen result. In covariate-adjusted logistic regression analyses, individuals with a positive depression screen result were more likely to have moderate/high substance use risk scores for prescription opioids (adjusted odds ratio [AOR]=2.06; 95% confidence interval [CI], 1.51–2.79); street opioids (AOR = 7.18; 95% CI, 2.57–20.01); cannabis (AOR = 2.00; 95% CI, 1.34–3.00); cocaine (AOR = 3.46; 95% CI, 1.46–8.22); tobacco (AOR = 1.59; 95% CI, 1.18–2.15); methamphetamine (AOR = 7.59; 95% CI, 2.58–22.35); prescription stimulants (AOR = 2.95; 95% CI, 1.59–5.49); and sedatives (AOR = 3.41; 95% CI, 2.43–4.79). Individuals with a positive depression screen were more likely to misuse prescription opioids (AOR = 3.46; 95% CI, 2.33–5.15), experience a prior overdose (AOR = 2.69; 95% CI, 1.76–4.11), report poorer general health (AOR = 0.25, 95% CI, 0.18–0.35), and report moderate/severe pain severity (AOR = 4.36, 95% CI, 2.80–6.77) and interference (AOR = 6.47, 95% CI, 4.08–10.26).

Conclusions: Individuals prescribed opioids with heightened depression were more likely to report other substance use, prescription opioid misuse, prior overdose, greater pain, and poorer health.

Related protocols: CTN-0093

Abstract:

Opioid use disorder (OUD) and chronic pain frequently co-occur. Little is known about change in pain during buprenorphine/naloxone (BUP/NX) maintenance and whether outcomes vary by pain levels. The present study examined changes in pain intensity and pain interference over 12 weeks of BUP/NX maintenance among participants with OUD and chronic pain (N=194). Differences in outcomes were assessed during BUP/NX maintenance (Week 12) and 2 months following a BUP/NX taper (Week 24). Data from Phase 2 of the CTN Prescription Opioid Addiction Treatment Study (POATS, CTN-0030) were used. Two latent transition models were conducted to characterize profiles and transitions between profiles of pain intensity or pain interference (estimated separately). Each model identified a high and low profile. In the pain interference model, the majority were classified in the low profile at baseline. In the pain intensity model, the majority were classified in the high profile at baseline. In both models, patients were more likely to remain in or transition to the low profiles by Week 12. Worse depression was associated with membership in the high pain interference profile at both timepoints. Women were more likely to be in the high pain intensity profile at baseline. Those in the high intensity and high pain interference profiles at Week 12 reported worse mental health quality of life (MH-QOL) at Week 12, as well as high pain intensity and high pain interference at Week 24.

Conclusions: For a subgroup of patients, high pain intensity and high pain interference remains unchanged during BUP/NX maintenance treatment.

Related protocols: CTN-0030

Abstract:

The objectives of the presentation are to 1) Quantify receipt of addiction treatment and retention in care among youth with opioid use disorder (OUD); 2) List common facilitators and barriers to receipt of addiction treatment from the perspective of clinicians, youth, and family members; and 3) Describe approaches to improving clinical services for youth with OUD.

Abstract:

Watch recording on YouTube.

Presented by Erin Bonar, PhD

Dr. Bonar presents results from pilot work on behavioral interventions delivered via telemedicine and a patient portal-like system the are now being testing in a large RCT as part of the NIH Heal Prevention Initiative. The interventions are rooted in Motivational Interviewing, include an emphasis on cognitive-behavioral skills, and are highly tailored for adolescents and young adults. These promising interventions build on prior efficacious behavioral interventions that showed reductions in primary substance use outcomes and secondary effects on prescription drug misuse.

Abstract:

Presented by: Kao-Ping Chua, MD, PhD, Primary Care Pediatrician, Assistant Professor, and Health Policy Researcher, Department of Pediatrics, Susan B. Meister Child Health Evaluation and Research Center, University of Michigan Medical School

The objectives of this presentation are to:

1. Review which opioid prescribing patterns are associated with
   adverse events, such as overdose, in children and young adults
2. Review the prevalence, prescribers, and safety of opioid
   prescribing to children and young adults
3. Describe ongoing efforts to reduce excessive opioid prescribing
   after surgery in children and young adults

Abstract:

This is the Primary Outcomes Article for CTN-0091. It has not been published in a peer-reviewed journal.

Practice facilitation is a commonly employed strategy to implement evidence-based programs into primary care settings. Preparing facilitators for this role requires an understanding of their training needs and support. Here we report on the experiences of facilitators who participated in a training program to support efforts to improve opioid medication management in primary care.

Trainees with prior QI experience were recruited for the six-month training program. Each trainee recruited a clinic for which they would serve as an external facilitator to implement the Six Building Blocks program. At the end of the six-months, we conducted two semi-structured interviews with each trainee. The interviews focused on facilitators and barriers that the trainees experienced during the training and support provided. Qualitative content analysis was used to analyze the transcribed interviews.

Three of the five trainees completed the program. In addition to the in-depth understanding of the Six BB program, trainees valued the opportunity to build peer relationships which provided a supportive peer support group. They valued the availability of more experienced facilitators who supported and mentored them. They also mentioned the importance of providing helpful tools and resources and the availability of a clinical expert. Barriers focused on factors internal to the trainees’ clinical setting, the trainees limited clinical knowledge about chronic pain, and difficulty maintaining momentum for change due to the flexible timeline of the program itself.

Conclusions: In addition to training on the content of an evidence-based programs, facilitators valued work with supportive peers and the mentoring of more experienced facilitators. Primary care improvement initiatives employing practice facilitators should consider these training needs and the resources required for this supportive infrastructure.

Related protocols: CTN-0091

Abstract:

Chronic pain is highly prevalent among patients with opioid use disorder (OUD). However, little is known about how pharmacological treatments for OUD, for example, extended-release naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX), affect pain. To begin addressing this question, researchers performed a secondary analysis of pain data on a large prospective 24-week, open-label, randomized-controlled comparative effectiveness trial of XR-NTX versus BUP-NX (X:BOT trial).

Participants’ pain status was measured by the EuroQol (EQ-5D). Based on their responses to the pain question at baseline, participants were dichotomized into “Pain” versus “No Pain” categories. Participant’s pain status was evaluated every 4 weeks. A mixed effects longitudinal logistic regression model was fitted to examine the differential effect of XR-NTX versus BUP-NX on pain, modelling pain at all available follow-up assessments, adjusted for age, sex, and baseline pain.

A total of 474 individuals who were successfully inducted onto their assigned medications were included in this analysis. Among participants endorsing pain at baseline, substantial reductions in pain were observed over the course of the study in both treatment groups. However reduction in pain was slightly greater in the group treated with XR-NTX than the one treated with BUP-NX (OR = 1.60 [95% CI: 1.07–2.40], P = 0.023).

Conclusions: Medication treatments of opioid use disorder were associated with a reduction in self-reported pain in patients reporting pain at the outset of treatment. Although both BUP-NX and XR-NTX were associated with substantial reductions in the proportion of patients reporting pain, XR-NTX was associated with a greater reduction, suggesting that opioid antagonist treatment may benefit patients with comorbid OUD and chronic pain. Future research using instruments and design specifically focused on pain could extend the present observations and evaluate their clinical significance.

Related protocols: CTN-0051