Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Active as of 2024-11-22 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 179637</b></p><a name="179637"> </a><a name="hc179637"> </a><a name="179637-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 8; Last updated: 2024-07-18 17:54:49+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>url</b>: <a href="Citation-179637.html">Citation 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</a></p><p><b>identifier</b>: FEvIR Object Identifier/179637, <code>https://pubmed.ncbi.nlm.nih.gov</code>/18508207, <a href="http://terminology.hl7.org/6.1.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.3</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-11-22 11:53:36+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</div><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html#citation-classification-type-fevir-platform-use">Citation Classification Type fevir-platform-use</a>: FEvIR Platform Use</td><td><span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier medline-base}">Medline Base</span></td></tr></table><p><b>jurisdiction</b>: <span title="Codes:{http://unstats.un.org/unsd/methods/m49/m49.htm 001}">World</span></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>approvalDate</b>: 2008-12-16</p><p><b>lastReviewDate</b>: 2021-10-20</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type citation-source}">Citation Source</span></p><p><b>classifier</b>: <span title="Codes:">MEDLINE</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type medline-owner}">MEDLINE Citation Owner</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value NLM}">National Library of Medicine, Index Section</span></p></blockquote><p><b>currentState</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type medline-medline}">Medline Citation Status of Medline</span>, <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-publication-status-ppublish}">PubMed PublicationStatus of ppublish</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-received}">PubMed Pubstatus of Received</span></p><p><b>period</b>: ?? --> 2007-11-22</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-revised}">PubMed Pubstatus of Revised</span></p><p><b>period</b>: ?? --> 2008-04-08</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-accepted}">PubMed Pubstatus of Accepted</span></p><p><b>period</b>: ?? --> 2008-04-09</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --> 2008-05-30 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-medline}">PubMed Pubstatus of Medline</span></p><p><b>period</b>: ?? --> 2008-12-17 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --> 2008-05-30 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pmc-release}">PubMed Pubstatus of PMC release</span></p><p><b>period</b>: ?? --> 2009-09-01</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/18508207, mid/NIHMS61453, <code>https://www.ncbi.nlm.nih.gov/pmc/</code>/PMC2613766, <code>https://doi.org</code>/10.1016/j.drugalcdep.2008.04.002, pii/S0376-8716(08)00140-3</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/title-type primary}">Primary title</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><div><p><strong>CONTEXT:</strong> Lofexidine is an alpha-2-adrenergic receptor agonist that is approved in the United Kingdom for the treatment of opioid withdrawal symptoms. Lofexidine has been reported to have more significant effects on decreasing opioid withdrawal symptoms with less hypotension than clonidine.
<strong>OBJECTIVE:</strong> To demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo.
<strong>DESIGN:</strong> An inpatient, Phase 3, placebo-controlled, double-blind, randomized multi-site trial with three phases: (1) opioid agonist stabilization phase (days 1-3), (2) detoxification/medication or placebo phase (days 4-8), and (3) post detoxification/medication phase (days 9-11).
<strong>SUBJECTS:</strong> Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo.
<strong>MAIN OUTCOME MEASURE:</strong> Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (second opioid detoxification treatment day).
<strong>RESULTS:</strong> Due to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (least squares means 19.5+/-2.1 versus 30.9+/-2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01).
<strong>CONCLUSIONS:</strong> Lofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Aghajanian GK. Central noradrenergic neurons: a locus for the functional interplay between alpha-2 adrenoceptors and opiate receptors. J Clin Psychiatry. 1982;43(6 Pt 2):20–24.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/6282816/">https://pubmed.ncbi.nlm.nih.gov/6282816/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/6282816</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Aghajanian GK. Tolerance of locus coeruleus neurones to morphine and suppression of withdrawal response by clonidine. Nature. 1978;276(5684):186–188.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/216919/">https://pubmed.ncbi.nlm.nih.gov/216919/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/216919</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Aigner A, Schmidt U. Lofexidine, a new, antihypertensive imidazoline derivative. Clinical profile of action with single-drug treatment and in combination with hydrochlorothiazide. Arzneimittelforschung. 1982;32(8a):976–983.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/6890373/">https://pubmed.ncbi.nlm.nih.gov/6890373/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/6890373</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Akhurst JS. The use of lofexidine by drug dependency units in the United Kingdom. Eur Addict Res. 1999;5(1):43–49.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/10085500/">https://pubmed.ncbi.nlm.nih.gov/10085500/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/10085500</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Arnsten AF, Cai JX, Goldman-Rakic PS. The alpha-2 adrenergic agonist guanfacine improves memory in aged monkeys without sedative or hypotensive side effects: evidence for alpha-2 receptor subtypes. J. Neurosci. 1998;8(11):4287–4298.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/2903226/">https://pubmed.ncbi.nlm.nih.gov/2903226/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/2903226</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Aston-Jones G, Hirata H, Akaoka H. Local opiate withdrawal in locus coeruleus in vivo. Brain Res. 1997;765(2):331–336.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/9313908/">https://pubmed.ncbi.nlm.nih.gov/9313908/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/9313908</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Bearn J, Gossop M, Strang J. Randomised double-blind comparison of lofexidine and methadone in the in-patient treatment of opiate withdrawal. Drug Alcohol Depend. 1996;43(1–2):87–91.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/8957147/">https://pubmed.ncbi.nlm.nih.gov/8957147/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/8957147</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Bearn J, Gossop M, Strang J. Accelerated lofexidine treatment regimen compared with conventional lofexidine and methadone treatment for in-patient opiate detoxification. Drug Alcohol Depend. 1998;50:227–232.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/9649976/">https://pubmed.ncbi.nlm.nih.gov/9649976/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/9649976</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Buccafusco JJ, Marshall DC. Dorsal root lesions block the expression of morphine withdrawal elicited from the rat spinal cord. Neurosci Lett. 1985;59(3):319–324.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/4058799/">https://pubmed.ncbi.nlm.nih.gov/4058799/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/4058799</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Carnwath T, Hardman J. Randomised double-blind comparison of lofexidine and clonidine in the out-patient treatment of opiate withdrawal. Drug Alcohol Depend. 1998;50(3):251–254.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/9649979/">https://pubmed.ncbi.nlm.nih.gov/9649979/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/9649979</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Freedman JE, Aghajanian GK. Opiate and alpha 2-adrenoceptor responses of rat amygdaloid neurons: co-localization and interactions during withdrawal. J Neurosci. 1985;5(11):3016–3024.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/2997411/">https://pubmed.ncbi.nlm.nih.gov/2997411/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/2997411</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Gold MS, Pottash AC, Sweeney DR, Extein I, Annitto WJ. Opiate detoxification with lofexidine. Drug Alcohol Depend. 1981;8(4):307–315.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/7338185/">https://pubmed.ncbi.nlm.nih.gov/7338185/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/7338185</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Gonzalez G, Oliveto A, Kosten TR. Combating opiate dependence: a comparison among the available pharmacological options. Expert Opin Pharmacother. 2004;5(4):713–725.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/15102558/">https://pubmed.ncbi.nlm.nih.gov/15102558/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/15102558</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Gossop M. Clonidine and the treatment of the opiate withdrawal syndrome. Drug Alcohol Depend. 1988;21(3):253–259.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/3048954/">https://pubmed.ncbi.nlm.nih.gov/3048954/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/3048954</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Gossop M. The development of a short opiate withdrawal scale. Addict Behav. 1990;15(5):487–490.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/2248123/">https://pubmed.ncbi.nlm.nih.gov/2248123/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/2248123</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Gowing LR, Farrell M, Ali RL, White JM. Alpha 2-adrenergic agonists in opioid withdrawal. Addiction. 2002;97(1):49–58.</p>
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Type</span></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>artifactAssessment</b>: Classifier added by Computable Publishing LLC</p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type citation-subset}">Citation subset</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#citationsubset IM}">IM</span></p></blockquote><blockquote><p><b>contributorship</b></p><p><b>complete</b>: true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor0">Yu E</a></p><p><b>forenameInitials</b>: E</p><p><b>affiliation</b>: University of Pennsylvania & Philadelphia Veterans Affairs Medical Center, Philadelphia VAMC 116, University & Woodland Avenues, Philadelphia, PA 19104, USA. yu_e@mail.trc.upenn.edu <yu_e@mail.trc.upenn.edu></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor1">Miotto K</a></p><p><b>forenameInitials</b>: K</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor2">Akerele E</a></p><p><b>forenameInitials</b>: E</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor3">Montgomery A</a></p><p><b>forenameInitials</b>: A</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor4">Elkashef A</a></p><p><b>forenameInitials</b>: A</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor5">Walsh R</a></p><p><b>forenameInitials</b>: R</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor6">Montoya I</a></p><p><b>forenameInitials</b>: I</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor7">Fischman MW</a></p><p><b>forenameInitials</b>: MW</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor8">Collins J</a></p><p><b>forenameInitials</b>: J</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor9">McSherry F</a></p><p><b>forenameInitials</b>: F</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor10">Boardman K</a></p><p><b>forenameInitials</b>: K</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor11">Davies DK</a></p><p><b>forenameInitials</b>: DK</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor12">O'Brien CP</a></p><p><b>forenameInitials</b>: CP</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor13">Ling W</a></p><p><b>forenameInitials</b>: W</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor14">Kleber H</a></p><p><b>forenameInitials</b>: H</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179637/contributor15">Herman BH</a></p><p><b>forenameInitials</b>: BH</p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor0</b></p><a name="179637/contributor0"> </a><a name="hc179637/contributor0"> </a><a name="179637/contributor0-en-US"> </a><p><b>name</b>: Elmer Yu </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor1</b></p><a name="179637/contributor1"> </a><a name="hc179637/contributor1"> </a><a name="179637/contributor1-en-US"> </a><p><b>name</b>: Karen Miotto </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor2</b></p><a name="179637/contributor2"> </a><a name="hc179637/contributor2"> </a><a name="179637/contributor2-en-US"> </a><p><b>name</b>: Evaristo Akerele </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor3</b></p><a name="179637/contributor3"> </a><a name="hc179637/contributor3"> </a><a name="179637/contributor3-en-US"> </a><p><b>name</b>: Ann Montgomery </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor4</b></p><a name="179637/contributor4"> </a><a name="hc179637/contributor4"> </a><a name="179637/contributor4-en-US"> </a><p><b>name</b>: Ahmed Elkashef </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor5</b></p><a name="179637/contributor5"> </a><a name="hc179637/contributor5"> </a><a name="179637/contributor5-en-US"> </a><p><b>name</b>: Robert Walsh </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor6</b></p><a name="179637/contributor6"> </a><a name="hc179637/contributor6"> </a><a name="179637/contributor6-en-US"> </a><p><b>name</b>: Ivan Montoya </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor7</b></p><a name="179637/contributor7"> </a><a name="hc179637/contributor7"> </a><a name="179637/contributor7-en-US"> </a><p><b>name</b>: Marian W Fischman </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor8</b></p><a name="179637/contributor8"> </a><a name="hc179637/contributor8"> </a><a name="179637/contributor8-en-US"> </a><p><b>name</b>: Joseph Collins </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor9</b></p><a name="179637/contributor9"> </a><a name="hc179637/contributor9"> </a><a name="179637/contributor9-en-US"> </a><p><b>name</b>: Frances McSherry </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor10</b></p><a name="179637/contributor10"> </a><a name="hc179637/contributor10"> </a><a name="179637/contributor10-en-US"> </a><p><b>name</b>: Kathy Boardman </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor11</b></p><a name="179637/contributor11"> </a><a name="hc179637/contributor11"> </a><a name="179637/contributor11-en-US"> </a><p><b>name</b>: David K Davies </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor12</b></p><a name="179637/contributor12"> </a><a name="hc179637/contributor12"> </a><a name="179637/contributor12-en-US"> </a><p><b>name</b>: Charles P O'Brien </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor13</b></p><a name="179637/contributor13"> </a><a name="hc179637/contributor13"> </a><a name="179637/contributor13-en-US"> </a><p><b>name</b>: Walter Ling </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor14</b></p><a name="179637/contributor14"> </a><a name="hc179637/contributor14"> </a><a name="179637/contributor14-en-US"> </a><p><b>name</b>: Herbert Kleber </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor15</b></p><a name="179637/contributor15"> </a><a name="hc179637/contributor15"> </a><a name="179637/contributor15-en-US"> </a><p><b>name</b>: Barbara H Herman </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #meshHeading0</b></p><a name="179637/meshHeading0"> </a><a name="hc179637/meshHeading0"> </a><a name="179637/meshHeading0-en-US"> </a><p><b>artifact</b>: <a href="#hc179637">Citation 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D000316}">Adrenergic alpha-Agonists</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000009}">adverse effects</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000627}">therapeutic use</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49488}">Yes</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D000328}">Adult</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D000701}">Analgesics, Opioid</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is Major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D003000}">Clonidine</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000009}">adverse effects</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000031}">analogs & derivatives</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49488}">Yes</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000627}">therapeutic use</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D003625}">Data Collection</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D004311}">Double-Blind Method</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D005260}">Female</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D006801}">Humans</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D008297}">Male</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D008875}">Middle Aged</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D011569}">Psychiatric Status Rating Scales</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: 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value="**CONTEXT:** Lofexidine is an alpha-2-adrenergic receptor agonist that is approved in the United Kingdom for the treatment of opioid withdrawal symptoms. Lofexidine has been reported to have more significant effects on decreasing opioid withdrawal symptoms with less hypotension than clonidine.
**OBJECTIVE:** To demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo.
**DESIGN:** An inpatient, Phase 3, placebo-controlled, double-blind, randomized multi-site trial with three phases: (1) opioid agonist stabilization phase (days 1-3), (2) detoxification/medication or placebo phase (days 4-8), and (3) post detoxification/medication phase (days 9-11).
**SUBJECTS:** Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo.
**MAIN OUTCOME MEASURE:** Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (second opioid detoxification treatment day).
**RESULTS:** Due to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (least squares means 19.5+/-2.1 versus 30.9+/-2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01).
**CONCLUSIONS:** Lofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification."/>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-22
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