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    v: Generated Narrative: Citation 179637 version: 21; Last updated: 2025-10-13 12:34:35+0000; Language: en Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/Citation/179637 identifier: FEvIR Object Identifier/179637, https://pubmed.ncbi.nlm.nih.gov/18508207 title: 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal. status: Active author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: Computable Publishing LLC contact: support@computablepublishing.com description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Medline Base copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/ approvalDate: 2008-12-16 lastReviewDate: 2021-10-20 classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2007-11-22 statusDate activity: PubMed Pubstatus of Revised period: ?? --> 2008-04-08 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2008-04-09 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2008-05-30 09:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2008-12-17 09:00:00+0000 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2008-05-30 09:00:00+0000 statusDate activity: PubMed Pubstatus of PMC release period: ?? --> 2009-09-01 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 Text * Primary title A Phase 3…
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    v: **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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