Generated Narrative: Citation 179637

url: Citation 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.

identifier: FEvIR Object Identifier/https://fevir.net/FOI/179637, https://pubmed.ncbi.nlm.nih.gov/18508207, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.3

version: 2.0.0-ballot

title: 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.

status: Active

date: 2024-12-19 14:29:51+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

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jurisdiction: World

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approvalDate: 2008-12-16

lastReviewDate: 2021-10-20

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period: ?? --> 2008-04-08

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citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/18508207, mid/NIHMS61453, https://www.ncbi.nlm.nih.gov/pmc//PMC2613766, https://doi.org/10.1016/j.drugalcdep.2008.04.002, pii/S0376-8716(08)00140-3

Titles

-	Type	Language	Text
*	Primary title	English	A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.

Abstracts

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Text

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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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affiliation: 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>

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Generated Narrative: Practitioner #contributor0

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name: Herbert Kleber

Generated Narrative: Practitioner #contributor15

name: Barbara H Herman

Generated Narrative: ArtifactAssessment #meshHeading0

artifact: Citation 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.

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