Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers
ABSTRACT Background Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double‐blind, cross‐over study was conducted to as...
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| Veröffentlicht in: | Addiction (Abingdon, England) England), 2010-04, Vol.105 (4), p.709-718 |
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| creator | Comer, Sandra D. Sullivan, Maria A. Vosburg, Suzanne K. Manubay, Jeanne Amass, Leslie Cooper, Ziva D. Saccone, Phillip Kleber, Herbert D. |
| description | ABSTRACT
Background Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double‐blind, cross‐over study was conducted to assess the intravenous abuse potential of buprenorphine/naloxone compared with buprenorphine in buprenorphine‐maintained injection drug users (IDUs).
Methods Intravenous heroin users (n = 12) lived in the hospital for 8–9 weeks and were maintained on each of three different sublingual buprenorphine doses (2 mg, 8 mg, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intravenous placebo, naloxone, heroin and low and high doses of buprenorphine and buprenorphine/naloxone were examined. Every participant received each test dose under the three buprenorphine maintenance dose conditions.
Results Intravenous buprenorphine/naloxone was self‐administered less frequently than buprenorphine or heroin (P |
| doi_str_mv | 10.1111/j.1360-0443.2009.02843.x |
| format | Article |
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Background Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double‐blind, cross‐over study was conducted to assess the intravenous abuse potential of buprenorphine/naloxone compared with buprenorphine in buprenorphine‐maintained injection drug users (IDUs).
Methods Intravenous heroin users (n = 12) lived in the hospital for 8–9 weeks and were maintained on each of three different sublingual buprenorphine doses (2 mg, 8 mg, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intravenous placebo, naloxone, heroin and low and high doses of buprenorphine and buprenorphine/naloxone were examined. Every participant received each test dose under the three buprenorphine maintenance dose conditions.
Results Intravenous buprenorphine/naloxone was self‐administered less frequently than buprenorphine or heroin (P < 0.0005). Participants were most likely to self‐administer drug intravenously when maintained on the lowest sublingual buprenorphine dose. Subjective ratings of ‘drug liking’ and ‘desire to take the drug again’ were lower for buprenorphine/naloxone than for buprenorphine or heroin (P = 0.0001). Participants reported that they would pay significantly less money for buprenorphine/naloxone than for buprenorphine or heroin (P < 0.05). Seven adverse events were reported; most were mild and transient.
Conclusions These data suggest that although the buprenorphine/naloxone combination has intravenous abuse potential, that potential is lower than it is for buprenorphine alone, particularly when participants received higher maintenance doses and lower buprenorphine/naloxone challenge doses. Buprenorphine/naloxone may be a reasonable option for managing the risk for buprenorphine misuse during opioid dependence treatment.</description><identifier>ISSN: 0965-2140</identifier><identifier>EISSN: 1360-0443</identifier><identifier>DOI: 10.1111/j.1360-0443.2009.02843.x</identifier><identifier>PMID: 20403021</identifier><identifier>CODEN: ADICE5</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Abuse liability ; Addiction ; Addictive behaviors ; Administration, Sublingual ; Adult ; Adult and adolescent clinical studies ; Analysis of Variance ; Behavior, Addictive ; Biological and medical sciences ; breakpoint ; Buprenorphine - administration & dosage ; Buprenorphine - adverse effects ; buprenorphine/naloxone ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug abuse ; Drug addiction ; Drug Combinations ; drug liking ; Drug use ; Female ; Heroin ; Heroin Dependence - economics ; Heroin Dependence - rehabilitation ; Humans ; intravenous ; Male ; Medical care ; Medical sciences ; Middle Aged ; Naloxone - administration & dosage ; Naloxone - adverse effects ; Narcotic Antagonists - administration & dosage ; Narcotic Antagonists - adverse effects ; Narcotics - administration & dosage ; Narcotics - adverse effects ; opioid dependence ; Patient Preference ; progressive-ratio ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Self Administration ; Substance abuse treatment ; Substance Abuse, Intravenous - rehabilitation ; Substance Withdrawal Syndrome - drug therapy ; Young Adult</subject><ispartof>Addiction (Abingdon, England), 2010-04, Vol.105 (4), p.709-718</ispartof><rights>2010 The Authors. Journal compilation © 2010 Society for the Study of Addiction</rights><rights>2015 INIST-CNRS</rights><rights>Journal compilation © 2010 Society for the Study of Addiction</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6573-27ab116b04180753a5c319c3ea0a0a8e3dd8f4bf1c837017140895532762535f3</citedby><cites>FETCH-LOGICAL-c6573-27ab116b04180753a5c319c3ea0a0a8e3dd8f4bf1c837017140895532762535f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1360-0443.2009.02843.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1360-0443.2009.02843.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22541302$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20403021$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Comer, Sandra D.</creatorcontrib><creatorcontrib>Sullivan, Maria A.</creatorcontrib><creatorcontrib>Vosburg, Suzanne K.</creatorcontrib><creatorcontrib>Manubay, Jeanne</creatorcontrib><creatorcontrib>Amass, Leslie</creatorcontrib><creatorcontrib>Cooper, Ziva D.</creatorcontrib><creatorcontrib>Saccone, Phillip</creatorcontrib><creatorcontrib>Kleber, Herbert D.</creatorcontrib><title>Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers</title><title>Addiction (Abingdon, England)</title><addtitle>Addiction</addtitle><description>ABSTRACT
Background Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double‐blind, cross‐over study was conducted to assess the intravenous abuse potential of buprenorphine/naloxone compared with buprenorphine in buprenorphine‐maintained injection drug users (IDUs).
Methods Intravenous heroin users (n = 12) lived in the hospital for 8–9 weeks and were maintained on each of three different sublingual buprenorphine doses (2 mg, 8 mg, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intravenous placebo, naloxone, heroin and low and high doses of buprenorphine and buprenorphine/naloxone were examined. Every participant received each test dose under the three buprenorphine maintenance dose conditions.
Results Intravenous buprenorphine/naloxone was self‐administered less frequently than buprenorphine or heroin (P < 0.0005). Participants were most likely to self‐administer drug intravenously when maintained on the lowest sublingual buprenorphine dose. Subjective ratings of ‘drug liking’ and ‘desire to take the drug again’ were lower for buprenorphine/naloxone than for buprenorphine or heroin (P = 0.0001). Participants reported that they would pay significantly less money for buprenorphine/naloxone than for buprenorphine or heroin (P < 0.05). Seven adverse events were reported; most were mild and transient.
Conclusions These data suggest that although the buprenorphine/naloxone combination has intravenous abuse potential, that potential is lower than it is for buprenorphine alone, particularly when participants received higher maintenance doses and lower buprenorphine/naloxone challenge doses. Buprenorphine/naloxone may be a reasonable option for managing the risk for buprenorphine misuse during opioid dependence treatment.</description><subject>Abuse liability</subject><subject>Addiction</subject><subject>Addictive behaviors</subject><subject>Administration, Sublingual</subject><subject>Adult</subject><subject>Adult and adolescent clinical studies</subject><subject>Analysis of Variance</subject><subject>Behavior, Addictive</subject><subject>Biological and medical sciences</subject><subject>breakpoint</subject><subject>Buprenorphine - administration & dosage</subject><subject>Buprenorphine - adverse effects</subject><subject>buprenorphine/naloxone</subject><subject>Cross-Over Studies</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug abuse</subject><subject>Drug addiction</subject><subject>Drug Combinations</subject><subject>drug liking</subject><subject>Drug use</subject><subject>Female</subject><subject>Heroin</subject><subject>Heroin Dependence - economics</subject><subject>Heroin Dependence - rehabilitation</subject><subject>Humans</subject><subject>intravenous</subject><subject>Male</subject><subject>Medical care</subject><subject>Medical sciences</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 - administration & dosage</subject><subject>Narcotics - adverse effects</subject><subject>opioid dependence</subject><subject>Patient Preference</subject><subject>progressive-ratio</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Self Administration</subject><subject>Substance abuse treatment</subject><subject>Substance Abuse, Intravenous - rehabilitation</subject><subject>Substance Withdrawal Syndrome - drug therapy</subject><subject>Young Adult</subject><issn>0965-2140</issn><issn>1360-0443</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkt9v0zAQxy0EYmXwL6AICfGU7vwrTh5Aqja2IU3AA2iIF8tJHeqS2p3djPZ9f_gutBTKCySKc_J97us73xGSURhTfE7mY8oLyEEIPmYA1RhYieb6ARntHQ_JCKpC5owKOCJPUpoDgCor8ZgcMRDAgdERuZvUfbJZ50ztOrfaZKHNnF9Fc2t96FNW98uIVlzOnLcn3nRhHbzNjJ8eujL04Or84Xa-MKiGn50eyM5sDMia4fCYnpJHremSfbb7H5PP528_nV7mVx8u3p1OrvKmkIrnTJma0qIGQUtQkhvZcFo13BrAt7R8Oi1bUbe0KbkCqrDwspKSM1UwyWXLj8mbre6yrxd22tgho04vo1uYuNHBOH3o8W6mv4VbzUVZMaVQ4NVOIIab3qaVXrjU2K4z3mJZWokClOB4-_8muaqwGRLJF3-R89BHvOmkaVVh3bRgCJVbqIkhpWjbfdIU9DASeq6Hzuuh83oYCf1zJPQaQ5__WfQ-8NcMIPByB5jUmK6Nxjcu_eaYFBRB5F5vuR-us5v_TkBPzs4GC-PzbbxLK7vex5v4XReKK6mv31_oj9eX6ktx_hXF7gHoi-PN</recordid><startdate>201004</startdate><enddate>201004</enddate><creator>Comer, Sandra D.</creator><creator>Sullivan, Maria A.</creator><creator>Vosburg, Suzanne K.</creator><creator>Manubay, Jeanne</creator><creator>Amass, Leslie</creator><creator>Cooper, Ziva D.</creator><creator>Saccone, Phillip</creator><creator>Kleber, Herbert D.</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>AAYXX</scope><scope>CITATION</scope><scope>7QG</scope><scope>7TK</scope><scope>8BJ</scope><scope>FQK</scope><scope>JBE</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7U1</scope><scope>7U2</scope><scope>C1K</scope><scope>5PM</scope></search><sort><creationdate>201004</creationdate><title>Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers</title><author>Comer, Sandra D. ; Sullivan, Maria A. ; Vosburg, Suzanne K. ; Manubay, Jeanne ; Amass, Leslie ; Cooper, Ziva D. ; Saccone, Phillip ; Kleber, Herbert D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6573-27ab116b04180753a5c319c3ea0a0a8e3dd8f4bf1c837017140895532762535f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Abuse liability</topic><topic>Addiction</topic><topic>Addictive behaviors</topic><topic>Administration, Sublingual</topic><topic>Adult</topic><topic>Adult and adolescent clinical studies</topic><topic>Analysis of Variance</topic><topic>Behavior, Addictive</topic><topic>Biological and medical sciences</topic><topic>breakpoint</topic><topic>Buprenorphine - administration & dosage</topic><topic>Buprenorphine - adverse effects</topic><topic>buprenorphine/naloxone</topic><topic>Cross-Over Studies</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug abuse</topic><topic>Drug addiction</topic><topic>Drug Combinations</topic><topic>drug liking</topic><topic>Drug use</topic><topic>Female</topic><topic>Heroin</topic><topic>Heroin Dependence - economics</topic><topic>Heroin Dependence - rehabilitation</topic><topic>Humans</topic><topic>intravenous</topic><topic>Male</topic><topic>Medical care</topic><topic>Medical sciences</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 - administration & dosage</topic><topic>Narcotics - adverse effects</topic><topic>opioid dependence</topic><topic>Patient Preference</topic><topic>progressive-ratio</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. Psychiatry</topic><topic>Self Administration</topic><topic>Substance abuse treatment</topic><topic>Substance Abuse, Intravenous - rehabilitation</topic><topic>Substance Withdrawal Syndrome - drug therapy</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Comer, Sandra D.</creatorcontrib><creatorcontrib>Sullivan, Maria A.</creatorcontrib><creatorcontrib>Vosburg, Suzanne K.</creatorcontrib><creatorcontrib>Manubay, Jeanne</creatorcontrib><creatorcontrib>Amass, Leslie</creatorcontrib><creatorcontrib>Cooper, Ziva D.</creatorcontrib><creatorcontrib>Saccone, Phillip</creatorcontrib><creatorcontrib>Kleber, Herbert D.</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>CrossRef</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>Risk Abstracts</collection><collection>Safety Science and Risk</collection><collection>Environmental Sciences and Pollution Management</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>Comer, Sandra D.</au><au>Sullivan, Maria A.</au><au>Vosburg, Suzanne K.</au><au>Manubay, Jeanne</au><au>Amass, Leslie</au><au>Cooper, Ziva D.</au><au>Saccone, Phillip</au><au>Kleber, Herbert D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers</atitle><jtitle>Addiction (Abingdon, England)</jtitle><addtitle>Addiction</addtitle><date>2010-04</date><risdate>2010</risdate><volume>105</volume><issue>4</issue><spage>709</spage><epage>718</epage><pages>709-718</pages><issn>0965-2140</issn><eissn>1360-0443</eissn><coden>ADICE5</coden><abstract>ABSTRACT
Background Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double‐blind, cross‐over study was conducted to assess the intravenous abuse potential of buprenorphine/naloxone compared with buprenorphine in buprenorphine‐maintained injection drug users (IDUs).
Methods Intravenous heroin users (n = 12) lived in the hospital for 8–9 weeks and were maintained on each of three different sublingual buprenorphine doses (2 mg, 8 mg, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intravenous placebo, naloxone, heroin and low and high doses of buprenorphine and buprenorphine/naloxone were examined. Every participant received each test dose under the three buprenorphine maintenance dose conditions.
Results Intravenous buprenorphine/naloxone was self‐administered less frequently than buprenorphine or heroin (P < 0.0005). Participants were most likely to self‐administer drug intravenously when maintained on the lowest sublingual buprenorphine dose. Subjective ratings of ‘drug liking’ and ‘desire to take the drug again’ were lower for buprenorphine/naloxone than for buprenorphine or heroin (P = 0.0001). Participants reported that they would pay significantly less money for buprenorphine/naloxone than for buprenorphine or heroin (P < 0.05). Seven adverse events were reported; most were mild and transient.
Conclusions These data suggest that although the buprenorphine/naloxone combination has intravenous abuse potential, that potential is lower than it is for buprenorphine alone, particularly when participants received higher maintenance doses and lower buprenorphine/naloxone challenge doses. Buprenorphine/naloxone may be a reasonable option for managing the risk for buprenorphine misuse during opioid dependence treatment.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>20403021</pmid><doi>10.1111/j.1360-0443.2009.02843.x</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Addiction (Abingdon, England), 2010-04, Vol.105 (4), p.709-718 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Abuse liability Addiction Addictive behaviors Administration, Sublingual Adult Adult and adolescent clinical studies Analysis of Variance Behavior, Addictive Biological and medical sciences breakpoint Buprenorphine - administration & dosage Buprenorphine - adverse effects buprenorphine/naloxone Cross-Over Studies Dose-Response Relationship, Drug Double-Blind Method Drug abuse Drug addiction Drug Combinations drug liking Drug use Female Heroin Heroin Dependence - economics Heroin Dependence - rehabilitation Humans intravenous Male Medical care Medical sciences Middle Aged Naloxone - administration & dosage Naloxone - adverse effects Narcotic Antagonists - administration & dosage Narcotic Antagonists - adverse effects Narcotics - administration & dosage Narcotics - adverse effects opioid dependence Patient Preference progressive-ratio Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Self Administration Substance abuse treatment Substance Abuse, Intravenous - rehabilitation Substance Withdrawal Syndrome - drug therapy Young Adult |
| title | Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers |
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