Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods
In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can...
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| Veröffentlicht in: | Journal of substance abuse treatment 2019-06, Vol.101, p.50-54 |
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| creator | Oviedo-Joekes, Eugenia Palis, Heather Guh, Daphne Marchand, Kirsten Brissette, Suzanne Harrison, Scott MacDonald, Scott Lock, Kurt Anis, Aslam H. Marsh, David C. Schechter, Martin T. |
| description | In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can attract and retain patients.
This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.
A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of −3.9; 95% CI = −8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.
As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone.
•High retention rates observed in the clinical trial were maintained with open label.•Daily hydromorphone doses did not differ in open label vs. double blind treatment.•Hydromorphone offered open-label can retain patients into treatment. |
| doi_str_mv | 10.1016/j.jsat.2019.03.012 |
| format | Article |
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This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.
A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of −3.9; 95% CI = −8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.
As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone.
•High retention rates observed in the clinical trial were maintained with open label.•Daily hydromorphone doses did not differ in open label vs. double blind treatment.•Hydromorphone offered open-label can retain patients into treatment.</description><identifier>ISSN: 0740-5472</identifier><identifier>EISSN: 1873-6483</identifier><identifier>DOI: 10.1016/j.jsat.2019.03.012</identifier><identifier>PMID: 31174713</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Analgesics ; Clinical research ; Clinical trials ; Double-blind studies ; Hydromorphone ; Inferiority ; Injectable hydromorphone ; Injectable opioid agonist treatment ; Narcotics ; Opioid use disorder ; Opioids ; Retention</subject><ispartof>Journal of substance abuse treatment, 2019-06, Vol.101, p.50-54</ispartof><rights>2019 Elsevier Inc.</rights><rights>Copyright © 2019 Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 2019</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-93dfc3d33be2b65d244feda47d2709c641a4e947fca0dc161d3c379217f49f393</citedby><cites>FETCH-LOGICAL-c410t-93dfc3d33be2b65d244feda47d2709c641a4e947fca0dc161d3c379217f49f393</cites><orcidid>0000-0002-8769-1785</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jsat.2019.03.012$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,30999,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31174713$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Oviedo-Joekes, Eugenia</creatorcontrib><creatorcontrib>Palis, Heather</creatorcontrib><creatorcontrib>Guh, Daphne</creatorcontrib><creatorcontrib>Marchand, Kirsten</creatorcontrib><creatorcontrib>Brissette, Suzanne</creatorcontrib><creatorcontrib>Harrison, Scott</creatorcontrib><creatorcontrib>MacDonald, Scott</creatorcontrib><creatorcontrib>Lock, Kurt</creatorcontrib><creatorcontrib>Anis, Aslam H.</creatorcontrib><creatorcontrib>Marsh, David C.</creatorcontrib><creatorcontrib>Schechter, Martin T.</creatorcontrib><title>Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods</title><title>Journal of substance abuse treatment</title><addtitle>J Subst Abuse Treat</addtitle><description>In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can attract and retain patients.
This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.
A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of −3.9; 95% CI = −8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.
As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone.
•High retention rates observed in the clinical trial were maintained with open label.•Daily hydromorphone doses did not differ in open label vs. double blind treatment.•Hydromorphone offered open-label can retain patients into treatment.</description><subject>Analgesics</subject><subject>Clinical research</subject><subject>Clinical trials</subject><subject>Double-blind studies</subject><subject>Hydromorphone</subject><subject>Inferiority</subject><subject>Injectable hydromorphone</subject><subject>Injectable opioid agonist treatment</subject><subject>Narcotics</subject><subject>Opioid use disorder</subject><subject>Opioids</subject><subject>Retention</subject><issn>0740-5472</issn><issn>1873-6483</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>7QJ</sourceid><recordid>eNp9kU1v1DAQhi1ERZfCH-CALHHpJam_GseIC1qVglSJSzlbjj1hHSV2sJ2i_nu82tIDBw6juTzvq9E8CL2jpKWEdldTO2VTWkaoaglvCWUv0I72kjed6PlLtCNSkOZaSHaOXuc8EUIYI_0rdM4plUJSvkPLfQJTFggF__blgH2YwBYzzIAPjy7FJab1EAN8xPu4rCb58BMnKJX3MVQau7gd4WH2wWFTJ64Q8GwGmHF57l4h-ejyG3Q2mjnD26d9gX58ubnff23uvt9-23--a6ygpDSKu9Fyx_kAbOiuHRNiBGeEdEwSZTtBjQAl5GgNcZZ21HHLpWJUjkKNXPELdHnqXVP8tUEuevHZwjybAHHLmnFBCJdM0Yp--Aed4pZCvU4zJhTtlexFpdiJsinmnGDUa_KLSY-aEn2UoSd9lKGPMjThusqoofdP1duwgHuO_P1-BT6dAKi_ePCQdLYeggXnU7WgXfT_6_8DREGcIg</recordid><startdate>20190601</startdate><enddate>20190601</enddate><creator>Oviedo-Joekes, Eugenia</creator><creator>Palis, Heather</creator><creator>Guh, Daphne</creator><creator>Marchand, Kirsten</creator><creator>Brissette, Suzanne</creator><creator>Harrison, Scott</creator><creator>MacDonald, Scott</creator><creator>Lock, Kurt</creator><creator>Anis, Aslam H.</creator><creator>Marsh, David C.</creator><creator>Schechter, Martin T.</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QJ</scope><scope>K7.</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-8769-1785</orcidid></search><sort><creationdate>20190601</creationdate><title>Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods</title><author>Oviedo-Joekes, Eugenia ; Palis, Heather ; Guh, Daphne ; Marchand, Kirsten ; Brissette, Suzanne ; Harrison, Scott ; MacDonald, Scott ; Lock, Kurt ; Anis, Aslam H. ; Marsh, David C. ; Schechter, Martin T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-93dfc3d33be2b65d244feda47d2709c641a4e947fca0dc161d3c379217f49f393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Analgesics</topic><topic>Clinical research</topic><topic>Clinical trials</topic><topic>Double-blind studies</topic><topic>Hydromorphone</topic><topic>Inferiority</topic><topic>Injectable hydromorphone</topic><topic>Injectable opioid agonist treatment</topic><topic>Narcotics</topic><topic>Opioid use disorder</topic><topic>Opioids</topic><topic>Retention</topic><toplevel>online_resources</toplevel><creatorcontrib>Oviedo-Joekes, Eugenia</creatorcontrib><creatorcontrib>Palis, Heather</creatorcontrib><creatorcontrib>Guh, Daphne</creatorcontrib><creatorcontrib>Marchand, Kirsten</creatorcontrib><creatorcontrib>Brissette, Suzanne</creatorcontrib><creatorcontrib>Harrison, Scott</creatorcontrib><creatorcontrib>MacDonald, Scott</creatorcontrib><creatorcontrib>Lock, Kurt</creatorcontrib><creatorcontrib>Anis, Aslam H.</creatorcontrib><creatorcontrib>Marsh, David C.</creatorcontrib><creatorcontrib>Schechter, Martin T.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>ProQuest Criminal Justice (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of substance abuse treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Oviedo-Joekes, Eugenia</au><au>Palis, Heather</au><au>Guh, Daphne</au><au>Marchand, Kirsten</au><au>Brissette, Suzanne</au><au>Harrison, Scott</au><au>MacDonald, Scott</au><au>Lock, Kurt</au><au>Anis, Aslam H.</au><au>Marsh, David C.</au><au>Schechter, Martin T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods</atitle><jtitle>Journal of substance abuse treatment</jtitle><addtitle>J Subst Abuse Treat</addtitle><date>2019-06-01</date><risdate>2019</risdate><volume>101</volume><spage>50</spage><epage>54</epage><pages>50-54</pages><issn>0740-5472</issn><eissn>1873-6483</eissn><abstract>In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can attract and retain patients.
This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.
A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of −3.9; 95% CI = −8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.
As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone.
•High retention rates observed in the clinical trial were maintained with open label.•Daily hydromorphone doses did not differ in open label vs. double blind treatment.•Hydromorphone offered open-label can retain patients into treatment.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31174713</pmid><doi>10.1016/j.jsat.2019.03.012</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-8769-1785</orcidid></addata></record> |
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| subjects | Analgesics Clinical research Clinical trials Double-blind studies Hydromorphone Inferiority Injectable hydromorphone Injectable opioid agonist treatment Narcotics Opioid use disorder Opioids Retention |
| title | Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods |
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