Emergency-Department Initiated Buprenorphine: Impact on Quality of Life Factors

Background: Emergency department (ED)-initiated medications for opioid use disorder (MOUD) have emerged as an effective strategy against the opioid epidemic. Opioid use disorder (OUD) patients engaged in ED-initiated MOUD programs have higher retention in treatment programs and improved outcomes with regard to overdose rates and mortality. It is unclear however, how engagement in ED-initiated MOUD programs might affect quality of life (QoL). We sought to describe demographic characteristics and QoL factors reported by patients engaged in ED-initiated MOUD and referral services. Methods: An ED MOUD-initiation program was launched in July 2019, with subsequent referral to definitive services. Enrolled patients were interviewed at intake, 3-months, and 6-months to ascertain QoL indices via the Government Performance and Results Act (GPRA) measures. Descriptive statistics and Fisher’s Exact were utilized to assess the data. Results: Through 12/2020, 89 participants were enrolled. The majority were white (85.4%), male (61.8%), and between the ages of 25-44 (75.3%). To-date, 31 participants (43.7% eligible) have completed 3-month follow-up and 28 (45.2% eligible) have competed 6-month follow-up. With regards to assessed QoL factors, over half demonstrated significant improvement, including 5 of 7 psychosocial factors, to include satisfaction with personal relationships, QoL self-rating, satisfaction with personal health, energy for everyday life, and satisfaction with self (p <.05). Financial needs met was the only objective QoL factor to demonstrate significant improvement during the follow-up time period. While not significant, homelessness also decreased, specifically 14 (15.7%) identified as homeless at intake as compared to one (3.7%) at 6-month follow-up. Additional trends toward decreased violence exposure and increased employment rates were also noted.Conclusions: In addition to decreasing illicit opioid drug use, maintenance of ED-initiated MOUD may positively impact broad QoL measures.

TumorSelect® Technology Enhancing the Safety and Efficacy of Cancer Chemotherapy

Veiled Therapeutics has developed an anticancer technology, TumorSelect® Technology, which combines proprietary anticancer prodrugs and nanotechnology, which takes advantage from current knowledge of human physiology. Tumors have a voracious appetite for cholesterol which facilitates tumor growth and fuels their proliferation. We have transformed this need into a stealth delivery system to disguise and deliver anticancer drugs with the assistance of both the human body and the tumor cell. Veiled’s designer prodrugs are assembled within pseudo-LDL nanoparticulates which carry them to tumor tissues where they are taken up, internalized and transformed into active drug and kill the cancer cells. This three-prong approach delivers the anticancer drug selectively to the tumors and thereby avoids or reduces the severe side effect toxicities associated with current chemotherapy. Reduction of side effect toxicity of cancer therapy by our technology will improve patient quality of life, patient retention in treatment regimes, more rapid patient recovery post treatment, and overall patient benefit.A. BackgroundThe costs of cancer, measured in terms of mortality, morbidity, direct costs of treatment, and costs of lost productivity are high.B. MethodsART-207 was synthesized; a pseudo-LDL lipid nanodispersion was formed; and mouse xenograft studies were performed. C. ResultsPreclinical toxicity, efficacy, and distribution data clearly show significant advantages of TumorSelect® paclitaxel over conventional Cremophor® formulations of paclitaxel. These advantages include:· Increased suppression of tumor growth and regrowth· Lower toxicity· Increased survival· Higher number of tumor free animals· Significantly lower concentrations of paclitaxel in non-target tissues· Significantly higher concentrations of paclitaxel in tumor tissueThus, data obtained demonstrated targeted drug delivery and support LDL-receptor dependent mechanism of selective cellular uptake by tumor tissue of TumorSelect® formulated paclitaxel.D. ConclusionsNon-target tissue concentrations of paclitaxel are significantly lower in non-tumored and tumored mice injected with formulated TumorSelect® paclitaxel compared with the mice injected with Cremophor® EL/EtOH (ethanol) paclitaxel (<20%).Tumor concentrations of paclitaxel are significantly higher in tumors of mice injected with formulated TumorSelect® paclitaxel compared with the mice injected with Cremophor® EL/EtOH paclitaxel (194%).Plasma and heart concentrations of paclitaxel are significantly lower in tumored vs. non-tumored animals injected with formulated TumorSelect® paclitaxel (<80%).Selective cellular uptake of TumorSelect® paclitaxel by tumors actively expressing LDL-receptors has been demonstrated.Tumor suppression observed was sustained for 63 days after Q1Dx5 dosing with TumorSelect® paclitaxel.TumorSelect® technology represents a potential major improvement in the clinical treatment of cancer through enhanced efficacy due to tumor-facilitated targeted delivery and reduced patient toxicity with its associated deleterious side effects.

Service evaluation of long acting buprenorphine subcutaneous injection (BUVIDAL) in the west Lothian community addictions service

Aims1. To establish if long acting buprenorphine subcutaneous injection retains patients in treatment.2. To obtain the patient opinion of long acting buprenorphine subcutaneous injection and ascertain if it improved other aspects of their life for example relationships and employment.MethodInformation was gathered from TRAK, the patient record recording system, and Illy, the prescribing system. This allowed data to be gathered on previous opiate substitute treatments and when the patient was commenced on the long acting buprenorphine injection. A patient questionnaire was used to obtain qualitative data on the patient's view of this treatment option.ResultWest Lothian Community Addictions Service starting offering long acting buprenorphine injection as a treatment option in March 2020. Since then there has been a consistent demand from patients to be commenced on this treatment. On 31st January 2021 39/53 (73.6%) of patients who had been commenced on long acting buprenorphine for 6 months had been retained on this treatment. Moreover, 3 patients were lost to treatment due to transfer to Her Majesty's Prison. Patients who were commenced on this treatment option were both new to treatment and those who had previously been difficult to retain on methadone or sublingual buprenorphine. The questionnaire supported the antidotal feedback that patients found this treatment option to be hugely beneficial.ConclusionLong acting buprenorphine injection has been well tolerated by patients and there has been a clear demand for this treatment option from patients accessing the service. It appears that the clarity of mind, that is associated with buprenorphine, has not been a barrier to retention in treatment. We have found the retention rate of the patients on this treatment option has been higher than the median 6 month retention for either methadone or buprenorphine, compared to a recent systematic review. In addition, it has helped patients consider employment, improve relationships and maintain a level of stability that they may not have previously achieved on either methadone or sublingual buprenorphine.

Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)”

Opioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.