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Evidence-Based Project, Part 2: Advanced Levels of Clinical Inquiry and Systematic Reviews Patrick Cannon Walden University Essent of Evidence-Based Pract-Spring 2023 Dr. Doris Hill April 2 nd , 2023

Clinical Issue: • With the advent of Fentanyl and other synthetic opiates available to people, the need for new and improved addiction recovery methods are needed more than ever. • Tactics to lessen the withdrawal symptoms and withdrawal period should be emphasized so we can keep patients in treatment. • Secondly, interventions to help patients stay clean after fully detoxing are needed to lessen the percentage of relapse. • The CDC reports that 107,375 Americans passed away from drug overdoses and drug poisonings in the year that ended in January 2022. Synthetic opioids like fentanyl were involved in a startling 67 percent of the fatalities. (Fentanyl Awareness. DEA, 2023). • When treating patients with active opioid use disorder, and patients who are on medicine for an opioid use disorder, the treatment of opioid withdrawal is a significant therapeutic problem in today’s day and age. Nowadays, treatment with partial agonists, such as buprenorphine, opioid receptor agonists, such as methadone, and 2-adrenergic receptor agonists(eg, clonidine and lofexidine) are regarded as the gold standard of care for medically controlled withdrawal. Two more modern medications that are also utilized for treatment include tramadol (which antagonizes the -opioid receptor) and tizanidine (which antagonizes the -2 agonism) (Srivastava, A. B., 2020).

PICOT Question • PICOT QUESTION: What are some alternative or conjunctive therapies to lessen or more effectively manage opiate withdrawal in the addiction recovery population during the withdrawal period? • This question developed out of a great need in the community but still encompasses many options to try. One size fits all doesn’t work for this population so many alternatives need to be tested and tried for efficacy. • Databases Used: CINAHL Plus with Full Text, Embase, MEDLINE with Full Text, and PubMed • The best case scenario was to find multiple systematic reviews on the topic and to be able to sift through them to find those I considered interesting. Because systematic reviews are at the top of the evidence pyramid, they have the highest level of evidence but are also rarer (Walden University Library. (n.d.-h). Quick Answers). • A systematic review is a type of article that examines research as a whole on a set of precisely stated criteria in order to answer a clinical question. Clinical trial and observational study data are routinely used to decide on the inclusion criteria. Reviews can be often updated, and assessments are carried out in accordance with strict rules (Walden University Library. (n.d.-i). Systematic review). • The efficacy of systematic reviews is tied in part to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) group, which primarily consists of Cochrane writers. A systematic will gather and then review all reports that have been published on the specified question or topic. It will then use a number of inclusion and exclusion criteria to gather the reports that should be included in the review, and it will then synthesize the results. Utilizing statistics to interpret the data requires a stringent review including meta-analysis (Selcuk, A.A, 2019).

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Doughty, B., Morgenson, D., & Brooks, T. (2019). Lofexidine: a newly FDA-approved, nonopioid treatment for opioid withdrawal. Annals of Pharmacotherapy, 53(7), 746-753. • Level 1 Evidence: The human studies published in English that dealt with human pharmacology, pharmacokinetics, pharmacodynamics, dosage, efficacy, and safety with regard to opioid withdrawal were the only ones that were included in the literature search. For inclusion, all phases of the trials for lofexidine as an opioid withdrawal therapy were examined. • How effective lofexidine was over placebo for this indication was shown in multiple randomized controlled trials and a Cochrane review. It has also been demonstrated that the efficacy of lofexidine is on par with other first- and second-line pharmacological interventions that are suggested. • In order to inform healthcare professionals in the usage of lofexidine for its new use for opiate withdrawal, this article encompasses studies that led to the drug's newly FDA-approved indication as well as other current literature released since its last major review. • This is an excellent study for the addiction recovery world due to the studies used being those in particular that were about its usage as an opioid dependence treatment. Some of the studies used were those that helped it achieve FDA approval, so they were extremely thorough as well.

Baker, T. E., & Chang, G. (2016). The use of auricular acupuncture in opioid use disorder: a systematic literature review. The American Journal on Addictions, 25(8), 592-602. • Level 1 Evidence: 4 randomized controlled trials met inclusion parameters, this systematic review is the first of its kind narrowing in on randomized trials using the NADA protocol with usage for opiate use disorder. • The exploration of complementary interventions, such as acupuncture, is a result of the addiction recovery movement's need for tailored, holistic, culturally sensitive care. • Despite countless worldwide studies, there is still no universal agreement on its effectiveness in OUD, largely because of methodological problems with earlier experiments. The National Acupuncture Detoxification Association (NADA) created an operationalized manual auricular acupuncture procedure in response to these problems, and it has subsequently grown to be the most popular in the US. • This study is interesting in the fact that it was the first of its kind using the NADA guidelines and serves as a guide for further research as well for further studies down the line. The usage of randomized trials and its narrowed vision on the usage for opiate use disorder allows for specific data to be drawn from it about it usage for this ailment.

Shah, K., Stout, B., & Caskey, H. (2020). Tramadol for the management of opioid withdrawal: a systematic review of randomized clinical trials. Cureus, 12(7). • Level 1 Evidence: All stages of clinical trials were used, as well as clinical and comparative studies that were investigated. After reviewing and narrowing down from 35, 9 studies were chosen for this systematic review • Usage of the terms "Tramadol" in combination with "Opioid Withdrawal" and "Opioid Detox," is how the research pieces were searched for in this systematic review • All studies were searched for and screened for compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards by the two independent authors (K Shah and H Caskey). • Tramadol has been around and used in medicine for years so the data available on it is very common but this study narrowed in on its use as a treatment for opioid withdrawal. Results were sifted through strictly and an emphasis was put on those papers that had to deal with opiate usage and tramadol to narrow the results.

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Elias, A. M., Pepin, M. J., & Brown, J. N. (2019). Adjunctive memantine for opioid use disorder treatment: a systematic review. Journal of Substance Abuse Treatment, 107, 38-43. • Level 1 Evidence: 6 randomized controlled studies were considered for analysis, 1 with memantine as the sole drug being used and 5 with memantine combined with either naltrexone, buprenorphine, or methadone. • Studies that used memantine in the treatment of opiate usage disorder were selected for consideration if they were prospective controlled studies. Excluded from consideration were animal studies, non-English articles, case studies, retrospective trials, unfinished research, human laboratory research, as well as studies with those who were not actively seeking detox or who were going through acute withdrawal. • Study size as well as duration, authors, publication date, patient demographics, memantine and comparative medicine treatment regimens, adjunct therapy, clinical outcomes, and reported adverse drug effects were all collected using a systematic data extraction process. Each author separately utilized the Jadad scale to assess the strength of the evidence in each study, and the group as a whole agreed on the final scores. • The Jadad scale is used to decide whether the random control trials are sufficiently double-blinded, correctly randomized, and describe the criteria and amount of those that dropped out from the studies. A trial's score will range from 0 to 5, with a higher number deeming a higher level of research. • Again, the collective usage of controlled and randomized studies allows for very accurate results and clean data. The studies pulled for this systematic review were thoroughly vetted and concise in the fact this narrows down on this drugs usage for opioid use disorder.

References Baker, T. E., & Chang, G. (2016). The use of auricular acupuncture in opioid use disorder: a systematic literature review. The American Journal on Addictions, 25(8), 592-602. Doughty, B., Morgenson, D., & Brooks, T. (2019). Lofexidine: a newly FDA-approved, nonopioid treatment for opioid withdrawal. Annals of Pharmacotherapy, 53(7), 746-753. Elias, A. M., Pepin, M. J., & Brown, J. N. (2019). Adjunctive memantine for opioid use disorder treatment: a systematic review. Journal of Substance Abuse Treatment, 107, 38-43. Fentanyl awareness. DEA. (n.d.). Retrieved March 21, 2023, from https://www.dea.gov/fentanylawareness Selçuk A. A. (2019). A Guide for Systematic Reviews: PRISMA. Turkish archives of otorhinolaryngology, 57(1), 57–58. https://doi.org/10.5152/tao.2019.4058 Shah, K., Stout, B., & Caskey, H. (2020). Tramadol for the management of opioid withdrawal: a systematic review of randomized clinical trials. Cureus, 12(7). Srivastava, A. B., Mariani, J. J., & Levin, F. R. (2020). New directions in the treatment of opioid withdrawal. Lancet (London, England), 395(10241), 1938–1948. https://doi.org/10.1016/S0140-6736(20)30852-7 Walden University Library. (n.d.-h). Quick Answers: How do I find a systematic review article related to health, medicine, or nursing? Retrieved September 6, 2019, from https://academicanswers.waldenu.edu/faq/72670 Walden University Library. (n.d.-i). Systematic review. Retrieved January 22, 2020, from https://academicguides.waldenu.edu/library/healthevidence/types#s-lg-box-1520654

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