Search

Background: Pain after spine surgery is difficult to manage, often requiring the use of opioid analgesics. While traditional "deceptive" or concealed placebo has been studied in trials and laboratory experiments, the acceptability and patient experience of taking honestly prescribed placebos, such as "open-label" placebo (non-deceptive placebo), or conditioned placebo (pairing placebo with another active pharmaceutical) is relatively unexamined., Methods: Qualitative thematic analysis was performed using semi-structured, post-treatment interviews with spine surgery patients (n = 18) who had received conditioned open-label placebo (COLP) during the first 2-3 weeks after surgery as part of a RCT. Interview transcripts were reviewed by 3 investigators using an immersion/crystallization approach, followed by iterative large-group discussions with additional investigators, to identify, refine, and codify emergent themes., Results: Patients' experiences and perceptions of COLP efficacy varied widely. Some emergent themes included the power of the mind over pain, how COLP might provide distraction from or agency over pain, bandwidth required and engagement with COLP, and its modulation of opioid tapering, as well as negative attitudes toward opioids and pill taking in general. Other themes included uncertainty about COLP efficacy, observations of how personality may relate to COLP efficacy, and a recognition of the greater impact of COLP on reduction of opioid use rather than on pain itself. Interestingly, participant uncertainty, disbelief, and skepticism were not necessarily associated with greater opioid consumption or worse pain., Conclusion: Participants provided insights into the experience of COLP which may help to guide its future utilization to manage acute pain and tapering from opioids., (© 2022. International Society of Behavioral Medicine.)

Abstract: Placebo effects have traditionally involved concealment or deception. However, recent evidence suggests that placebo effects can also be elicited when prescribed transparently as "open-label placebos" (OLPs), and that the pairing of an unconditioned stimulus (eg, opioid analgesic) with a conditioned stimulus (eg, placebo pill) can lead to the conditioned stimulus alone reducing pain. In this randomized control trial, we investigated whether combining conditioning with an OLP (COLP) in the immediate postoperative period could reduce daily opioid use and postsurgical pain among patients recovering from spine surgery. Patients were randomized to COLP or treatment as usual, with both groups receiving unrestricted access to a typical opioid-based postoperative analgesic regimen. The generalized estimating equations method was used to assess the treatment effect of COLP on daily opioid consumption and pain during postoperative period from postoperative day (POD) 1 to POD 17. Patients in the COLP group consumed approximately 30% less daily morphine milligram equivalents compared with patients in the treatment as usual group during POD 1 to 17 (-14.5 daily morphine milligram equivalents; 95% CI: [-26.8, -2.2]). Daily worst pain scores were also lower in the COLP group (-1.0 point on the 10-point scale; 95% CI: [-2.0, -0.1]), although a significant difference was not detected in average daily pain between the groups (-0.8 point; 95% CI: [-1.7, 0.2]). These findings suggest that COLP may serve as a potential adjuvant analgesic therapy to decrease opioid consumption in the early postoperative period, without increasing pain., (Copyright © 2021 International Association for the Study of Pain.)

Background: Injured patients are at risk for prolonged opioid use after discharge from care. Limited evidence exists regarding how continued opioid use may be related to opioid medication misuse and opioid use disorder (OUD) following injury. This pilot study characterized opioid consumption patterns, health characteristics, and substance use among patients with active prescriptions for opioid medications following injury care. Methods: This study was a cross-sectional screening survey combined with medical record review from February 2017 to March 2018 conducted among outpatient trauma and orthopedic surgery clinic patients. Eligible patients were 18-64 years of age, admitted/discharged for an injury or trauma-related orthopedic surgery, returning for clinic follow-up ≤6 months post hospital discharge after the index injury, prescribed opioid pain medication at discharge, and currently taking an opioid medication (from discharge or a separate prescription post discharge). Data collected included demographic, substance use, mental health, and physical health information. Descriptive and univariate statistics were calculated to characterize the population and opioid-related risks. Results: Seventy-one participants completed the survey (92% response). Most individuals (≥75%) who screened positive for misuse or OUD reported no nonmedical/illicit opioid use in the year before the index injury. A positive depression screen was associated with a 3.88 times increased likelihood for misuse or OUD (95% confidence interval [CI] = 1.1-13.5). Nonopioid illicit drug use (odds ratio [OR] = 1.89, 95% CI = 1.1-3.4) and opioid craving (OR = 1.29, 95% CI = 1.1-1.5) were also associated with increased likelihood for misuse or OUD. Number of emergency department visits in the 3 years previous to the index injury was associated with a 22% likelihood of being misuse or OUD positive (95% CI = 1.0-1.5). Conclusions: Patients with behavioral health concerns and greater emergency department utilization may have heightened risk for experiencing adverse opioid-related outcomes. Future research must further establish these findings and possibly develop protocols to identify patients at risk prior to pain management planning.

Background: Stemming the opioid epidemic requires testing novel interventions. Toward this goal, feasibility and acceptability of a Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention was examined along with its impact on medication misuse and concomitant health conditions., Methods: We conducted a two-group randomized trial in 2 community pharmacies. We screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index. Participants were assigned to standard medication counseling (SMC) or SMC + BMI-MTM (referred to as BMI-MTM herein). BMI-MTM consists of a pharmacist-led medication counseling/brief motivational session and 8-weekly patient navigation sessions. Assessments were at baseline, 2-, and 3-months. Primary outcomes included feasibility, acceptability, and mitigation of opioid medication misuse. Secondary outcomes included pain and depression. Outcomes were analyzed with descriptive and multivariable statistics (intent-to-treat [ITT] and adjusted for number of sessions completed [NUMSESS])., Results: Thirty-two participants provided informed consent (74.4% consent rate; SMC n = 17, BMI-MTM n = 15; 3-month assessment retention ≥93%). Feasibility was demonstrated by all BMI-MTM recipients completing the pharmacist session and an average of 7 navigation sessions. BMI-MTM recipients indicated ≥4.2 (5 maximum) level of satisfaction with the pharmacist-led session, and 92.4% were satisfied with navigation sessions. Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001., Numsess: AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = 14.0, 95% CI = 3.28, 24.8, p = 0.01), and depression (ITT: B= -0.44; 95% CI=-0.65, -0.22; p < 0.001., Numsess: B= -0.64; 95% CI=-0.82, -0.46; p < 0.001)., Conclusions: BMI-MTM is a feasible misuse intervention associated with superior satisfaction and outcomes than SMC. Future research should test BMI-MTM in a large-scale, fully-powered trial., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: Opioid misuse in the context of chronic noncancer pain (CNCP) is a multifaceted and complex issue. As opioid misuse and corresponding rates of addiction and overdose deaths exceed epidemic proportions, there is an urgent need for research in this area. The objective of this review is to evaluate the literature addressing psychosocial interventions targeting CNCP and prescription opioid misuse., Design: A systematic search of PubMed, MEDLINE, PsychINFO, ClinicalTrials.gov was conducted to identify studies evaluating psychosocial interventions targeting CNCP and prescription opioid misuse. The review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines., Results: 56 peer-reviewed research articles from 1993 to July, 2016, which included studies of psychosocial interventions for CNCP and opioid use disorders. Studies that examined psychosocial interventions for CNCP, treatment modalities included: cognitive behavioral therapy (CBT), acceptance and commitment therapy, mindfulness-based cognitive therapy and mindfulness-based stress reduction, and chronic pain self-management programs. The psychosocial interventions for opioid misuse included: CBT and relapse prevention, motivational enhancement therapy and stages of change, contingency management, and self-help and peer support-based groups., Conclusions: The findings of this review offer clinical insight and reinforce the importance of psychosocial interventions in CNCP and opioid use disorders. However, little empirical data are available to guide practitioners in treating patients with CNCP who misuse opioid medications, and thus future research on integrated approaches, is needed.

Objectives: Community pharmacy continues to play a crucial role in the national response to the opioid epidemic. The purpose of this article is to describe the protocol for a pilot study that is examining the feasibility and acceptability of the Motivational Intervention-Medication Therapy Management (MI-MTM) model. This study also examines the preliminary clinical effect of MI-MTM for improving opioid medication misuse and patient activation in self-management of health conditions that increase risk for misuse., Design: MI-MTM is a pharmacy-based integrated care model made up of 4 evidence-based practices: medication therapy management; brief motivational intervention; patient navigation; and naloxone training and referral. To test MI-MTM compared with Standard Medication Counseling (SMC), we are conducting a 2-group randomized single-blinded controlled trial with assessments at 3 time points., Setting and Participants: The study is being conducted within a western Pennsylvania university-based community pharmacy with 46 patients with opioid misuse (MI-MTM = 23; SMC = 23)., Main Outcome Measures: Feasibility will be measured by capturing patient completion rate of MI-MTM sessions. Acceptability will be measured by administering satisfaction surveys regarding pharmacist and patient navigator services. Acceptability will also be captured by conducting intensive qualitative interviews. Preliminary effect of the intervention on misuse will be measured with the use of the Prescription Opioid Misuse Index and the Opioid Compliance Checklist. Activation in self-management will be measured with the use of the Patient Activation Measure., Results: This project is currently recruiting, and results are to come., Conclusion: This study is the first in the United States to implement an evidence-based integrated behavioral intervention into the community pharmacy setting to address opioid medication misuse among pharmacy patients. The results of this study will provide necessary foundational data that allow further testing of this intervention model in a larger trial., (Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Community pharmacists are well-positioned to address the US opioid medication crisis, which has created a need to detect misuse risk in order to provide optimal patient care., Objectives: This study sought to identify community pharmacy patient subgroups at risk for opioid medication misuse., Methods: This study was a cross-sectional survey that examined behavioral, mental, and physical health characteristics among patients filling opioid pain medications. A convenience sample of adult patients filling opioid pain medications who were not receiving cancer treatment were screened in 2 urban and 2 rural community pharmacies in southwestern Pennsylvania. Patient subgroups were identified using latent class analysis. Latent class regression analysis was used to examine the association between subgroup membership and misuse., Results: A total of 333 patients completed the survey (response rate 71.4%). Latent class analysis results showed that a 3-class solution best fit the data, which were labeled: mental health (8.4%, n = 28), poor health (79.6%, n = 265), and hazardous alcohol use (12%, n = 40). Individuals within the mental health subgroup had an increased risk for opioid medication misuse (Odds Ratio = 6.23, 95% CI = 5.13-7.33)., Conclusion: These findings demonstrate heterogeneity of this population receiving prescribed opioids and the potential to identify subgroups with high misuse risk. These findings also support routine screening of patients filling opioid medications and suggest the need for evidence-based patient-centered intervention development., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Opioid misuse imposes a disproportionately heavy burden on individuals living in rural areas. Community pharmacy has the potential to expand and coordinate with health professionals to identify and intervene with those who misuse opioids., Objective: Rural and urban community pharmacy patients were recruited in this pilot project to describe and compare patterns of opioid misuse., Methods: We administered a health screening survey in 4 community pharmacies among patients filling opioid medications. Univariate statistics were used to assess differences in health characteristics and opioid medication misuse behaviors between rural and urban respondents. Multivariable statistics were used to identify risk factors associated with rural and urban opioid misuse., Results: A total of 333 participants completed the survey. Participants in rural settings had poorer overall health, higher pain levels, lower education, and a higher rate of unemployment compared to patients in urban pharmacies. Rural respondents with illicit drug use (adjustable odds ratio [aOR]: 14.34, 95% confidence interval [CI] = 2.16-95.38), posttraumatic stress disorder (aOR: 5.44, 95% CI = 1.52-19.50), and ≤high school education (aOR: 6.68, 95% CI = 1.06-42.21) had increased risk for opioid misuse., Conclusions: Community pharmacy represents a promising resource for potential identification of opioid misuse, particularly in rural communities. Continued research must extend these findings and work to establish collaborative services in rural settings.

Objectives: Opioid pain medication misuse is a major concern for US public health. The purpose of this article is to: 1) describe the demographic and physical, behavioral, and mental health characteristics of patients who fill opioid medications in community pharmacy settings; and 2) describe the extent of opioid medication misuse behaviors among these patients., Design: We recruited and screened a convenience sample of patients with the use of a tablet computer-based assessment protocol that examined behavioral, mental, and physical health. Descriptive and inferential statistics were calculated to describe respondents and their opioid medication misuse and health characteristics., Setting: Patients were screened in 2 urban and 2 rural community pharmacies in southwestern Pennsylvania., Participants: Survey participants were adult patients filling opioid pain medications who were not currently receiving treatment for a cancer diagnosis., Intervention: None., Main Outcome Measures: Validated screening measures included the Prescription Opioid Misuse Index, Alcohol Use Disorders Identification Test C, Short Form 12, Drug Abuse Screening Test 10, Primary Care Post-traumatic Stress Disorder (PTSD) screen, and the Patient Health Questionnaire 2., Results: A total of 333 patients were screened (71.2% response rate). Nearly the entire population reported pain above and general health below national norms. Hydrocodone (19.2%) and morphine (20.8%) were found to be the medications with the highest rates of misuse-with hydrocodone having more than 4 times higher odds of misuse compared with other medications (adjusted odds ratio [AOR] 4.48, 95% confidence interval [CI] 1.1-17.4). Patients with positive screens for illicit drug use (AOR 8.07, 95% CI 2.7-24.0), PTSD (AOR 5.88, 95% CI 2.3-14.7), and depression (AOR 2.44, 95% CI 1.0-5.9) also had significantly higher odds for misuse compared with those with negative screening results., Conclusion: These findings provide important foundational data that suggest implementation of regular opioid misuse screening protocols within community pharmacies. Such screening activities could foster a culture of prevention and overall reduction for misuse among patients filling opioid medications in community pharmacies., (Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)