I am a
Home I AM A Search Login

Human Studies

Share this

Benefit and Risk Evaluation of Biased μ-Receptor Agonist Oliceridine versus Morphine.

To improve understanding of the respiratory behavior of oliceridine, a μ-opioid receptor agonist that selectively engages the G-protein-coupled signaling pathway with reduced activation of the β-arrestin pathway, the authors compared its utility function with that of morphine. It was hypothesized that at equianalgesia, oliceridine will produce less respiratory depression than morphine and that this is reflected in a superior utility.

Learn More >

Moderated mediation for exercise maintenance in pain and posttraumatic stress disorder: A randomized trial.

This study utilizes the Science of Behavior Change (SOBC) experimental medicine approach to evaluate the effects of a 3-month, individually prescribed progressive exercise training program on neurobiological, cognitive and motivational mechanisms by which our exercise-training paradigm may foster exercise maintenance. We will investigate hypothesized relationships between exercise-training associated augmentation of neuropeptide Y (NPY) system function and improvements in self-regulation and reward sensitivity-cognitive control and motivational processes posited to promote self-efficacy and intrinsic motivation, which have been shown to predict exercise maintenance. This study will recruit Veterans with chronic low back pain and posttraumatic stress disorder (PTSD). Procedures include a baseline, acute cardiopulmonary exercise challenge assessment that will inform the exercise prescription for a 12-week progressive exercise training program comprised of three 45-minute aerobic exercise sessions per week-all of which will be supervised by an exercise physiologist. Additionally, a week-7 and week-14 exercise challenge assessment will track changes in NPY system function and the variables of interest. We hypothesize that increases in the capacity to release NPY in response to acute exercise testing will be associated with improvements in self-regulation and reward sensitivity, which will in turn be associated with self-efficacy and intrinsic motivation to maintain regular exercise. Ninety participants will be randomized either to the "active exercise training condition" or to the "wait list symptom monitoring condition". The study aims to demonstrate the feasibility of procedures and elucidate mechanisms relevant to developing individually prescribed, motivationally based exercise regimens to reduce negative consequences of PTSD and low back pain over the long-term. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Learn More >

Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation.

The current opioid crisis was fueled by escalation of opioid dosing among patients with chronic pain. Yet, there are few evidence-based psychological interventions for opioid dose reduction among chronic pain patients treated with long-term opioid analgesics. Mindfulness-Oriented Recovery Enhancement (MORE), which was designed to target mechanisms underpinning chronic pain and opioid misuse, has shown promising results in 2 randomized clinical trials (RCTs) and could facilitate opioid sparing and tapering by bolstering self-regulation. Here we tested this hypothesis with secondary analyses of data from a Stage 2 RCT. Chronic pain patients (N = 95) on long-term opioid therapy were randomized to 8 weeks of MORE or a support group (SG) control delivered in primary care. Opioid dose was assessed with the Timeline Followback through 3-month follow-up. Heart rate variability (HRV) during mindfulness meditation was quantified as an indicator of self-regulatory capacity. Participants in MORE evidenced a greater decrease in opioid dosing (a 32% decrease) by follow-up than did the SG, F(2, 129.77) = 5.35, p = .006, d = 1.07. MORE was associated with a significantly greater increase in HRV during meditation than was the SG. Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034). MORE may boost self-regulatory strength via mindfulness and thereby facilitate self-control over opioid use, leading to opioid dose reduction in people with chronic pain. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Learn More >

Assessing Digital Health Implementation for a Pediatric Chronic Pain Intervention: Comparing the RE-AIM and BIT Frameworks Against Real-World Trial Data and Recommendations for Future Studies.

Digital health interventions have demonstrated efficacy for several conditions including for pediatric chronic pain. However, the process of making interventions available to end users in an efficient and sustained way is challenging and remains a new area of research. To advance this field, comprehensive frameworks have been created.

Learn More >

Pain rehabilitation’s dual power: Treatment for chronic pain and prevention of opioid-related risks.

The purpose of this article is to provide a data-driven exploration of an interdisciplinary pain rehabilitation program (PRP) as a viable option for addressing the dual crises of chronic pain and opioid use. Psychologists are crucial providers in the PRP, in both intervention and leadership roles. There is well-established literature supporting pain rehabilitation as an effective treatment for chronic pain and functioning, but there are few studies examining the effects of pain rehabilitation on opioid misuse risk. We evaluated data from 60 patients with diverse chronic pain conditions who completed an interdisciplinary PRP to evaluate changes in pain, functioning (self-report and objective physical measure), psychological symptoms, and health-related quality of life. To evaluate the effect of pain rehabilitation on opioid-related risks, we examined opioid use and opioid misuse behaviors (measured by the Current Opioid Misuse Measure; COMM) pre- and posttreatment. Results demonstrated statistically significant improvements in all outcomes, with medium effect sizes for pain severity and large effect sizes for functioning, psychological symptoms, and emotional quality of life. Fifty-eight percent of patients were on opioid medications at entry compared with 15% at discharge. Among patients who entered on opioids, mean COMM scores were significantly reduced from above the cutoff for misuse risk (M = 13.57) to below the cutoff (M = 5.86). Overall, this study provided strong support for pain rehabilitation as an effective treatment for chronic pain and related suffering, while also providing a prevention-based opportunity for reducing opioid-related risk. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Learn More >

Migraine and tension-type headache in Germany. Prevalence and disease severity from the BURDEN 2020 Burden of Disease Study.

Headache disorders are widespread among women and men in Germany and are primarily associated with restrictions on quality of life. The two most common types of headache disorders are migraine and tension-type headache. In order to gain valid estimates of the prevalence of these conditions, a cross-sectional telephone-based survey was conducted among adults in Germany (N=5,009) between October 2019 and March 2020. The frequency, duration, the characteristics and comorbidities associated with headache were measured using the diagnostic criteria defined in the International Classification of Headache Disorders. 57.5% of women and 44.4% of men in Germany stated that they had had a headache in the last twelve months. 14.8% of women and 6.0% of men meet all of the diagnostic criteria for migraine. Tension-type headache affects 10.3% of women and 6.5% of men. Migraine and tension-type headache are predominantly found among people of working age and steadily decrease with age. Migraine is often accompanied by comorbidities such as depressive symptoms and anxiety disorders. People affected by headache disorders tend to receive very little professional medical care, with only a minority seeking treatment within a year. These results provide a comprehensive picture of the population-related impact of headache disorders and are used in the BURDEN 2020 study to quantify key indicators for burden of disease assessment.

Learn More >

Anhedonia in chronic pain and prescription opioid misuse.

Both acute and chronic pain can disrupt reward processing. Moreover, prolonged prescription opioid use and depressed mood are common in chronic pain samples. Despite the prevalence of these risk factors for anhedonia, little is known about anhedonia in chronic pain populations.

Learn More >

Patient race and opioid misuse history influence provider risk perceptions for future opioid-related problems.

In response to the dual public health crises of chronic pain and opioid use, providers have become more vigilant about assessing patients for risk of opioid-related problems. Little is known about how providers are making these risk assessments. Given previous studies indicating that Black patients are at increased risk for suboptimal pain care, which may be related to stereotypes about drug abuse, the current study examined how patient race and previous opioid misuse behaviors impact providers' risk assessments for future prescription opioid-related problems. Physician residents and fellows (N = 135) viewed videos and read vignettes about 8 virtual patients with chronic pain who varied by race (Black/White) and history of prescription opioid misuse (absent/present). Providers rated patients' risk for future prescription opioid-related adverse events, misuse/abuse, addiction, and diversion, and also completed measures of implicit racial attitudes and explicit beliefs about race differences in pain. Two significant interactions emerged indicating that Black patients were perceived to be at greater risk for future adverse events (when previous misuse was absent) and diversion (when previous misuse was present). Significant main effects indicated that Black patients and patients with previous misuse were perceived to be at greater risk for future misuse/abuse of prescription opioids, and that patients with previous misuse were perceived to be at greater risk of addiction. These findings suggest that racial minorities and patients with a history of prescription opioid misuse are particularly vulnerable to any unintended consequences of efforts to stem the dual public health crises of chronic pain and opioid use. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Learn More >

Benefit and Risk Evaluation of Biased μ-Receptor Agonist Oliceridine versus Morphine.

To improve understanding of the respiratory behavior of oliceridine, a μ-opioid receptor agonist that selectively engages the G-protein-coupled signaling pathway with reduced activation of the β-arrestin pathway, the authors compared its utility function with that of morphine. It was hypothesized that at equianalgesia, oliceridine will produce less respiratory depression than morphine and that this is reflected in a superior utility.

Learn More >

The relative contribution of pain and psychological factors to opioid misuse: A 6-month observational study.

There is a pressing need to better understand the factors contributing to prescription opioid misuse among patients with chronic pain. Cross-sectional studies have been conducted in this area, but longitudinal studies examining the determinants of prescription opioid misuse repeatedly over the course of opioid therapy have yet to be conducted. The main objective of this study was to examine the relative contribution of pain and psychological factors to the occurrence of opioid misuse among patients with chronic pain prescribed opioids. Of particular interest was to examine whether pain intensity and psychological factors were more strongly associated with certain types of opioid misuse behaviors. Patients with chronic pain (n = 194) prescribed long-term opioid therapy enrolled in this longitudinal observational cohort study. Patients completed baseline measures and were then followed for 6 months. Opioid misuse was assessed once a month using self-report measures, and urine toxicology screens complemented patients' reports of opioid misuse. Heightened pain intensity levels were associated with a greater likelihood of opioid misuse (p = .014). However, pain intensity was no longer significantly associated with opioid misuse when controlling for psychological factors (i.e., negative affect, catastrophizing). Subsequent analyses revealed that higher levels of catastrophizing were associated with a greater likelihood of running out of opioid medication early, even after controlling for patients' levels of pain intensity and negative affect (p = .016). Our findings provide new insights into the determinants of prescription opioid misuse and have implications for the nature of interventions that may be used to reduce specific types of opioid misuse behaviors. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Learn More >

Search