BackgroundOstomy surgeries involving the placement of an ostomy bag (eg, colostomy, ileostomy, urostomy, etc) have been shown to have a negative impact on health-related quality of life. To date, no studies have been conducted examining what impact, if any, wearable biosensors have on the health-related quality of life of ostomy patients.ObjectiveIn the present study, we plan to assess the quality of life of ostomy patients using the Ostom-i alert sensor, a portable, wearable, Bluetooth-linked biosensor that facilitates easier ostomy bag output measurements. We hypothesize that using the Ostom-i alert sensor will result in an improved, ostomy-specific, health-related quality of life as compared to baseline measurement before the use of the sensor.MethodsA total of 20 ostomy patients will be screened and recruited to participate in this prospective, observational, cross-over pilot study using an Ostom-i alert sensor for one month. The primary outcome of this study will compare ostomy-specific, health-related quality of life at baseline (prior to Ostom-i alert sensor use) to ostomy-specific, health-related quality of life after 2 and 4 weeks of Ostom-i use by utilizing the City of Hope Quality of Life Questionnaire for Patients with an Ostomy. Secondary outcomes of general health-related quality of life and adjustment to ostomy will be evaluated using the Medical Outcomes Study 36-item short form health survey and the Olbrisch Ostomy Adjustment Scale Short Form 2.ResultsThe project was funded by the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University School of Medicine. Enrollment is currently underway and data analysis is expected to be completed in 2018.ConclusionsProposed benefits of mobile, internet-linked personal health monitors, such as the Ostom-i, include a reduction in the cost of care by reducing resource utilization and infection rates, improving patient-provider communication, reducing time spent as an inpatient as well as improved quality of life. Prior studies have demonstrated decreased health-related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i alert sensor affects the health-related quality of life of its users. The Ostom-i alert sensor has the potential to improve quality of life of users by giving them the freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner.Trial RegistrationClinicalTrials.gov NCT02319434; https://clinicaltrials.gov/ct2/show/NCT02319434 (Archived at WebCite at http://www.webcitation.org/6xhFDThmq)

Objectives Individuals taking opioids for an extended period of time may become physically dependent, and will therefore experience opioid withdrawal should they stop taking the medication. Previous work in animal and human models has shown that the serotonin (5-HT3) receptor may be implicated in opioid withdrawal. In this study, we investigated if ondansetron, a 5-HT3-receptor antagonist, could reduce the symptoms of opioid withdrawal after chronic opioid exposure in humans. Methods In this double-blinded, randomized crossover study, thirty-three chronic back pain patients (N=33) were titrated onto sustained-release oral morphine for 30 days. Following titration, participants attended two study sessions, one week apart, in which opioid withdrawal was induced with intravenous naloxone, with or without 8mg intravenous ondansetron pretreatment. Opioid withdrawal symptoms were assessed by a blinded research assistant (objective opioid withdrawal score - OOWS) and by the research participant (subjective opioid withdrawal score - SOWS). Results Clinically significant signs of withdrawal were observed during both the ondansetron (ΔOOWS = 3.58 ± 2.22, p < .0001; ΔSOWS = 12.48 ± 11.18, p < .0001) and placebo sessions (ΔOOWS = 3.55 ± 2.39, p < .0001; ΔSOWS = 12.21 ± 10.72, p < .0001), but no significant differences were seen between the treatment sessions in either the OOWS or SOWS scores. Conclusion We hypothesized that ondansetron would reduce opioid withdrawal symptoms in human subjects, but found no difference in withdrawal severity between ondansetron and placebo sessions. These findings suggest that more investigation may be necessary to determine if 5-HT3-receptor antagonists are suitable treatment options for opioid withdrawal.

This study presents a preliminary investigation of the regional changes in neural activity during acute opioid withdrawal. The fMRI acute opioid withdrawal model may serve as a tool for studying opioid dependence and withdrawal in human participants.

Background Treatments for reducing opioid withdrawal are limited and prone to problematic side effects. Laboratory studies, clinical observations, and limited human trial data suggest 5-HT3-receptor antagonists and antihistamines may be effective. Objectives This double-blind, crossover, placebo-controlled study employing an acute physical dependence model evaluated whether (i) treatment with a 5-HT3-receptor antagonist (palonosetron) would reduce opioid withdrawal symptoms, and (ii) co-administration of an antihistamine (hydroxyzine) would enhance any treatment effect. Methods At timepoint T=0, healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either a) placebo, b) palonosetron IV (0.75 mg), or c) palonosetron IV (0.75 mg) and hydroxyzine PO (100 mg) in a crossover study design. This was followed at T=30 by intravenous morphine (10mg/70kg). At T=165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T=170, 180, respectively). Baseline measurements were recorded at T=-30 and T=-15. Results Comparison of average baseline OOWS scores with OOWS scores obtained fifteen minutes after naloxone was significant (p=0.0001). Scores from fifteen minutes post-naloxone infusion showed significant differences in OOWS scores between treatment groups: placebo, 3.7 ± 2.4; palonosetron, 1.5± 0.97; and palonosetron with hydroxyzine, 0.2 ± .1333. Conclusions Pretreatment with palonosetron significantly reduced many signs of experimental-induced opioid withdrawal. Co-administration with hydroxyzine further reduced opioid withdrawal severity. These results suggest that 5-HT3 receptor antagonists, alone or in combination with an antihistamine, may be useful in the treatment of opioid withdrawal.

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Objective In this study, we investigated if chronic opioid exposure leads to changes in immune signaling pathways. Method We used phospho-flow cytometry to study intracellular signaling in immune cells of patients with chronic opioid exposure. PBMCs were stimulated with cytokines (IFN-α, IFN-γ, IL-2, IL-6, IL-7, IL-10, IL-21), then stained to analyze 6 lymphocyte subsets and monocytes for phosphorylated STATs (signal transducers and activators of transcription), in particular p-STATs 1, 3 and 5. Results After one month of opioid exposure as compared to baseline, IL-2 stimulation of B cells resulted in significantly elevated pSTAT3 levels whereas IFN-γ stimulation resulted in significantly reduced pSTAT5 levels. CD4+ T cell subsets showed reduced pSTAT3 induction in response to multiple cytokine stimuli, and reduced pSTAT1 and pSTAT5 induction with IFN-γ. Similar reductions in pSTAT3 and pSTAT5 induction were seen in CD8+CD45RA+ T cells with several cytokine stimuli. In monocytes, IL-7 and IL-21 stimulation resulted in significantly decreased pSTAT1 levels. No significant changes in pSTAT signaling was found in non-B non-T cells after stimulation with various cytokines. In addition, acute opioid withdrawal via intravenous naloxone resulted in significantly increased pSTAT1 and pSTAT5 levels after IFN-γ stimulation in CD8+ T cells. Conclusion One month of opioid exposure significantly reduced cytokine-induced levels of phospho-STAT signaling. These findings suggest that chronic opioid exposure suppresses immune signaling pathways.