Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone
Aims To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open‐label sublingual buprenorphine/naloxone tablets (BNX). Design Randomized, double‐blind, placebo‐controlled trial. Subjects...
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| Veröffentlicht in: | Addiction (Abingdon, England) England), 2013-12, Vol.108 (12), p.2141-2149 |
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| container_title | Addiction (Abingdon, England) |
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| creator | Rosenthal, Richard N. Ling, Walter Casadonte, Paul Vocci, Frank Bailey, Genie L. Kampman, Kyle Patkar, Ashwin Chavoustie, Steven Blasey, Christine Sigmon, Stacey Beebe, Katherine L. |
| description | Aims
To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open‐label sublingual buprenorphine/naloxone tablets (BNX).
Design
Randomized, double‐blind, placebo‐controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open‐label BNX (12–16 mg/day) (n = 119).
Setting
Twenty addiction treatment centers.
Participants
Adult out‐patients (ages 18–65) with DSM‐IV‐TR opioid dependence.
Measurements
The primary efficacy end‐point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).
Findings
The BI CDF was significantly different from placebo (P |
| doi_str_mv | 10.1111/add.12315 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4669043</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1463036325</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5105-5b1a776f0f9022369d13ed1f3a4182c14b0e1893ef7c3f7bad846681265c7cd63</originalsourceid><addsrcrecordid>eNpdkk1v1DAQhiMEoqVw4A8gSwiJS7r-iO2EQ6WyhRZRARKgcrMce9K6JHawE2i58c_xdpelYB9s6X3m9cx4iuIxwfskr4W2dp9QRvidYpcwgUtcVexusYsbwUtKKrxTPEjpEmMs66a6X-xQ1pCGN3y3-PVyHiP4EMcL5wG5Yey1nxLqQkRTBD0N4CcUOhRGF5xFFkbwFryBFyhqb8PgfoJFJgyjji4Fj6aAsoeBNqCsozS3vfPns-5Re_uphdd9uAoeHhb3Ot0neLQ594rPr199Wp6Up--P3ywPT0vDCeYlb4mWUnS4azClTDSWMLCkY7oiNTWkajGQumHQScM62WpbV0LUhApupLGC7RUHa99xbgewJtcVda_G6AYdr1XQTv2reHehzsN3lW0aXLFs8HxjEMO3GdKkBpcM9LlhEOakSCUYZoJRntGn_6GXYY654hXF67wlppl6cjujbSp_ficDzzaATkb3XW64cekvJxtKMV5xizX3w_VwvdUJVqvxUHk81M14qMOjo5tLjijXES5NcLWN0PGrEpJJrs7eHau3H-UJOVt-UF_Yb7ohvl0</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1458585702</pqid></control><display><type>article</type><title>Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone</title><source>MEDLINE</source><source>Wiley Journals</source><creator>Rosenthal, Richard N. ; Ling, Walter ; Casadonte, Paul ; Vocci, Frank ; Bailey, Genie L. ; Kampman, Kyle ; Patkar, Ashwin ; Chavoustie, Steven ; Blasey, Christine ; Sigmon, Stacey ; Beebe, Katherine L.</creator><creatorcontrib>Rosenthal, Richard N. ; Ling, Walter ; Casadonte, Paul ; Vocci, Frank ; Bailey, Genie L. ; Kampman, Kyle ; Patkar, Ashwin ; Chavoustie, Steven ; Blasey, Christine ; Sigmon, Stacey ; Beebe, Katherine L.</creatorcontrib><description>Aims
To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open‐label sublingual buprenorphine/naloxone tablets (BNX).
Design
Randomized, double‐blind, placebo‐controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open‐label BNX (12–16 mg/day) (n = 119).
Setting
Twenty addiction treatment centers.
Participants
Adult out‐patients (ages 18–65) with DSM‐IV‐TR opioid dependence.
Measurements
The primary efficacy end‐point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).
Findings
The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician‐rated (P < 0.0001) and patient‐rated (P < 0.0001) withdrawal, lower patient‐ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant‐site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non‐inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (−10.7, 6.2)].
Conclusions
Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non‐inferior to sublingual buprenorphine/naloxone tablets.</description><identifier>ISSN: 0965-2140</identifier><identifier>EISSN: 1360-0443</identifier><identifier>DOI: 10.1111/add.12315</identifier><identifier>PMID: 23919595</identifier><identifier>CODEN: ADICE5</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Addiction ; Addictive behaviors ; Addicts ; Administration, Sublingual ; Adolescent ; Adult ; Adult and adolescent clinical studies ; Adults ; Aged ; Biological and medical sciences ; Buprenorphine ; Buprenorphine - administration & dosage ; Buprenorphine - adverse effects ; Desintoxication. Drug withdrawal ; Double-Blind Method ; Drug addiction ; Drug Implants ; Female ; Humans ; maintenance therapy ; Male ; Medical sciences ; Medical treatment ; Middle Aged ; Naloxone - administration & dosage ; Naloxone - adverse effects ; Narcotic Antagonists - administration & dosage ; Narcotic Antagonists - adverse effects ; Narcotics ; Opiate Substitution Treatment - methods ; opioid dependence ; Opioid-Related Disorders - drug therapy ; Patients ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Sample surveys ; Substance abuse treatment ; Tablets ; Transplants & implants ; treatment adherence ; Treatment Outcome ; Treatments ; Young Adult</subject><ispartof>Addiction (Abingdon, England), 2013-12, Vol.108 (12), p.2141-2149</ispartof><rights>2013 Society for the Study of Addiction</rights><rights>2015 INIST-CNRS</rights><rights>2013 Society for the Study of Addiction.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5105-5b1a776f0f9022369d13ed1f3a4182c14b0e1893ef7c3f7bad846681265c7cd63</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fadd.12315$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fadd.12315$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27922005$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23919595$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosenthal, Richard N.</creatorcontrib><creatorcontrib>Ling, Walter</creatorcontrib><creatorcontrib>Casadonte, Paul</creatorcontrib><creatorcontrib>Vocci, Frank</creatorcontrib><creatorcontrib>Bailey, Genie L.</creatorcontrib><creatorcontrib>Kampman, Kyle</creatorcontrib><creatorcontrib>Patkar, Ashwin</creatorcontrib><creatorcontrib>Chavoustie, Steven</creatorcontrib><creatorcontrib>Blasey, Christine</creatorcontrib><creatorcontrib>Sigmon, Stacey</creatorcontrib><creatorcontrib>Beebe, Katherine L.</creatorcontrib><title>Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone</title><title>Addiction (Abingdon, England)</title><addtitle>Addiction</addtitle><description>Aims
To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open‐label sublingual buprenorphine/naloxone tablets (BNX).
Design
Randomized, double‐blind, placebo‐controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open‐label BNX (12–16 mg/day) (n = 119).
Setting
Twenty addiction treatment centers.
Participants
Adult out‐patients (ages 18–65) with DSM‐IV‐TR opioid dependence.
Measurements
The primary efficacy end‐point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).
Findings
The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician‐rated (P < 0.0001) and patient‐rated (P < 0.0001) withdrawal, lower patient‐ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant‐site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non‐inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (−10.7, 6.2)].
Conclusions
Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non‐inferior to sublingual buprenorphine/naloxone tablets.</description><subject>Addiction</subject><subject>Addictive behaviors</subject><subject>Addicts</subject><subject>Administration, Sublingual</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Adult and adolescent clinical studies</subject><subject>Adults</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Buprenorphine</subject><subject>Buprenorphine - administration & dosage</subject><subject>Buprenorphine - adverse effects</subject><subject>Desintoxication. Drug withdrawal</subject><subject>Double-Blind Method</subject><subject>Drug addiction</subject><subject>Drug Implants</subject><subject>Female</subject><subject>Humans</subject><subject>maintenance therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Middle Aged</subject><subject>Naloxone - administration & dosage</subject><subject>Naloxone - adverse effects</subject><subject>Narcotic Antagonists - administration & dosage</subject><subject>Narcotic Antagonists - adverse effects</subject><subject>Narcotics</subject><subject>Opiate Substitution Treatment - methods</subject><subject>opioid dependence</subject><subject>Opioid-Related Disorders - drug therapy</subject><subject>Patients</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Sample surveys</subject><subject>Substance abuse treatment</subject><subject>Tablets</subject><subject>Transplants & implants</subject><subject>treatment adherence</subject><subject>Treatment Outcome</subject><subject>Treatments</subject><subject>Young Adult</subject><issn>0965-2140</issn><issn>1360-0443</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkk1v1DAQhiMEoqVw4A8gSwiJS7r-iO2EQ6WyhRZRARKgcrMce9K6JHawE2i58c_xdpelYB9s6X3m9cx4iuIxwfskr4W2dp9QRvidYpcwgUtcVexusYsbwUtKKrxTPEjpEmMs66a6X-xQ1pCGN3y3-PVyHiP4EMcL5wG5Yey1nxLqQkRTBD0N4CcUOhRGF5xFFkbwFryBFyhqb8PgfoJFJgyjji4Fj6aAsoeBNqCsozS3vfPns-5Re_uphdd9uAoeHhb3Ot0neLQ594rPr199Wp6Up--P3ywPT0vDCeYlb4mWUnS4azClTDSWMLCkY7oiNTWkajGQumHQScM62WpbV0LUhApupLGC7RUHa99xbgewJtcVda_G6AYdr1XQTv2reHehzsN3lW0aXLFs8HxjEMO3GdKkBpcM9LlhEOakSCUYZoJRntGn_6GXYY654hXF67wlppl6cjujbSp_ficDzzaATkb3XW64cekvJxtKMV5xizX3w_VwvdUJVqvxUHk81M14qMOjo5tLjijXES5NcLWN0PGrEpJJrs7eHau3H-UJOVt-UF_Yb7ohvl0</recordid><startdate>201312</startdate><enddate>201312</enddate><creator>Rosenthal, Richard N.</creator><creator>Ling, Walter</creator><creator>Casadonte, Paul</creator><creator>Vocci, Frank</creator><creator>Bailey, Genie L.</creator><creator>Kampman, Kyle</creator><creator>Patkar, Ashwin</creator><creator>Chavoustie, Steven</creator><creator>Blasey, Christine</creator><creator>Sigmon, Stacey</creator><creator>Beebe, Katherine L.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QG</scope><scope>7TK</scope><scope>8BJ</scope><scope>FQK</scope><scope>JBE</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>5PM</scope></search><sort><creationdate>201312</creationdate><title>Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone</title><author>Rosenthal, Richard N. ; Ling, Walter ; Casadonte, Paul ; Vocci, Frank ; Bailey, Genie L. ; Kampman, Kyle ; Patkar, Ashwin ; Chavoustie, Steven ; Blasey, Christine ; Sigmon, Stacey ; Beebe, Katherine L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5105-5b1a776f0f9022369d13ed1f3a4182c14b0e1893ef7c3f7bad846681265c7cd63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Addiction</topic><topic>Addictive behaviors</topic><topic>Addicts</topic><topic>Administration, Sublingual</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Adult and adolescent clinical studies</topic><topic>Adults</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Buprenorphine</topic><topic>Buprenorphine - administration & dosage</topic><topic>Buprenorphine - adverse effects</topic><topic>Desintoxication. Drug withdrawal</topic><topic>Double-Blind Method</topic><topic>Drug addiction</topic><topic>Drug Implants</topic><topic>Female</topic><topic>Humans</topic><topic>maintenance therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Middle Aged</topic><topic>Naloxone - administration & dosage</topic><topic>Naloxone - adverse effects</topic><topic>Narcotic Antagonists - administration & dosage</topic><topic>Narcotic Antagonists - adverse effects</topic><topic>Narcotics</topic><topic>Opiate Substitution Treatment - methods</topic><topic>opioid dependence</topic><topic>Opioid-Related Disorders - drug therapy</topic><topic>Patients</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. Psychiatry</topic><topic>Sample surveys</topic><topic>Substance abuse treatment</topic><topic>Tablets</topic><topic>Transplants & implants</topic><topic>treatment adherence</topic><topic>Treatment Outcome</topic><topic>Treatments</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rosenthal, Richard N.</creatorcontrib><creatorcontrib>Ling, Walter</creatorcontrib><creatorcontrib>Casadonte, Paul</creatorcontrib><creatorcontrib>Vocci, Frank</creatorcontrib><creatorcontrib>Bailey, Genie L.</creatorcontrib><creatorcontrib>Kampman, Kyle</creatorcontrib><creatorcontrib>Patkar, Ashwin</creatorcontrib><creatorcontrib>Chavoustie, Steven</creatorcontrib><creatorcontrib>Blasey, Christine</creatorcontrib><creatorcontrib>Sigmon, Stacey</creatorcontrib><creatorcontrib>Beebe, Katherine L.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Animal Behavior Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>International Bibliography of the Social Sciences (IBSS)</collection><collection>International Bibliography of the Social Sciences</collection><collection>International Bibliography of the Social Sciences</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Addiction (Abingdon, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rosenthal, Richard N.</au><au>Ling, Walter</au><au>Casadonte, Paul</au><au>Vocci, Frank</au><au>Bailey, Genie L.</au><au>Kampman, Kyle</au><au>Patkar, Ashwin</au><au>Chavoustie, Steven</au><au>Blasey, Christine</au><au>Sigmon, Stacey</au><au>Beebe, Katherine L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone</atitle><jtitle>Addiction (Abingdon, England)</jtitle><addtitle>Addiction</addtitle><date>2013-12</date><risdate>2013</risdate><volume>108</volume><issue>12</issue><spage>2141</spage><epage>2149</epage><pages>2141-2149</pages><issn>0965-2140</issn><eissn>1360-0443</eissn><coden>ADICE5</coden><abstract>Aims
To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open‐label sublingual buprenorphine/naloxone tablets (BNX).
Design
Randomized, double‐blind, placebo‐controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open‐label BNX (12–16 mg/day) (n = 119).
Setting
Twenty addiction treatment centers.
Participants
Adult out‐patients (ages 18–65) with DSM‐IV‐TR opioid dependence.
Measurements
The primary efficacy end‐point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).
Findings
The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician‐rated (P < 0.0001) and patient‐rated (P < 0.0001) withdrawal, lower patient‐ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant‐site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non‐inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (−10.7, 6.2)].
Conclusions
Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non‐inferior to sublingual buprenorphine/naloxone tablets.</abstract><cop>Oxford</cop><pub>Blackwell Publishing Ltd</pub><pmid>23919595</pmid><doi>10.1111/add.12315</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0965-2140 |
| ispartof | Addiction (Abingdon, England), 2013-12, Vol.108 (12), p.2141-2149 |
| issn | 0965-2140 1360-0443 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4669043 |
| source | MEDLINE; Wiley Journals |
| subjects | Addiction Addictive behaviors Addicts Administration, Sublingual Adolescent Adult Adult and adolescent clinical studies Adults Aged Biological and medical sciences Buprenorphine Buprenorphine - administration & dosage Buprenorphine - adverse effects Desintoxication. Drug withdrawal Double-Blind Method Drug addiction Drug Implants Female Humans maintenance therapy Male Medical sciences Medical treatment Middle Aged Naloxone - administration & dosage Naloxone - adverse effects Narcotic Antagonists - administration & dosage Narcotic Antagonists - adverse effects Narcotics Opiate Substitution Treatment - methods opioid dependence Opioid-Related Disorders - drug therapy Patients Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Sample surveys Substance abuse treatment Tablets Transplants & implants treatment adherence Treatment Outcome Treatments Young Adult |
| title | Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone |
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