Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (Morphine-ADER Injection-Molded Tablets) vs Extended-Release Morphine Administered Intranasally in Nondependent Recreational Opioid Users
Abstract Objective. To compare the relative human abuse potential after insufflation of manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine ER tablets. Methods. A randomized, double-blind, double-dummy, active- and placeb...
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| creator | Webster, Lynn R. Smith, Michael D. Lawler, John Lindhardt, Karsten Dayno, Jeffrey M. |
| description | Abstract
Objective. To compare the relative human abuse potential after insufflation of manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine ER tablets.
Methods. A randomized, double-blind, double-dummy, active- and placebo-controlled five-way crossover study was performed with adult volunteers who were experienced, nondependent, recreational opioid users. After intranasal (IN) administration of manipulated high-volume (HV) morphine-ADER-IMT (60 mg), participants were randomized (1:1:1:1) to receive IN manipulated low-volume (LV) morphine ER (60 mg), IN manipulated LV morphine-ADER-IMT, intact oral morphine-ADER-IMT (60 mg), and placebo in crossover fashion. Pharmacodynamic and pharmacokinetic assessments included peak effect of drug liking (Emax; primary endpoint) using drug liking visual analog scale (VAS) score, Emax using overall drug liking, and take drug again (TDA) VASs scores, and mean abuse quotient (AQ), a pharmacokinetic parameter associated with drug liking.
Results. Forty-six participants completed the study. After insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT, drug liking Emax was significantly lower (P |
| doi_str_mv | 10.1093/pm/pnw219 |
| format | Article |
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Objective. To compare the relative human abuse potential after insufflation of manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine ER tablets.
Methods. A randomized, double-blind, double-dummy, active- and placebo-controlled five-way crossover study was performed with adult volunteers who were experienced, nondependent, recreational opioid users. After intranasal (IN) administration of manipulated high-volume (HV) morphine-ADER-IMT (60 mg), participants were randomized (1:1:1:1) to receive IN manipulated low-volume (LV) morphine ER (60 mg), IN manipulated LV morphine-ADER-IMT, intact oral morphine-ADER-IMT (60 mg), and placebo in crossover fashion. Pharmacodynamic and pharmacokinetic assessments included peak effect of drug liking (Emax; primary endpoint) using drug liking visual analog scale (VAS) score, Emax using overall drug liking, and take drug again (TDA) VASs scores, and mean abuse quotient (AQ), a pharmacokinetic parameter associated with drug liking.
Results. Forty-six participants completed the study. After insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT, drug liking Emax was significantly lower (P < 0.0001) compared with IN morphine ER. Overall drug liking and TDA Emax values were significantly lower (P < 0.0001) after insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT compared with IN morphine ER. Mean AQ was lower after insufflation of HV (9.2) and LV (2.3) morphine-ADER-IMT or ingestion of oral morphine-ADER-IMT (5.5) compared with insufflation of LV morphine ER (37.2).
Conclusions. All drug liking, take drug again, and abuse quotient endpoints support a significantly lower abuse potential with insufflation of manipulated morphine-ADER-IMT compared with manipulated and insufflated non-AD ER morphine.</description><identifier>ISSN: 1526-2375</identifier><identifier>EISSN: 1526-4637</identifier><identifier>DOI: 10.1093/pm/pnw219</identifier><identifier>PMID: 27651510</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Abuse-Deterrent Formulations - methods ; Administration, Intranasal ; Administration, Oral ; Adult ; Analgesics, Opioid - administration & dosage ; Analgesics, Opioid - pharmacokinetics ; Cross-Over Studies ; Delayed-Action Preparations - administration & dosage ; Delayed-Action Preparations - pharmacokinetics ; Double-Blind Method ; Drug abuse ; Female ; Humans ; Injection ; Male ; Morphine ; Morphine - administration & dosage ; Morphine - pharmacokinetics ; Narcotics ; Opioid-Related Disorders - prevention & control ; Opioids ; OPIOIDS & SUBSTANCE USE DISORDERS SECTION ; Pharmacodynamics ; Tablets</subject><ispartof>Pain medicine (Malden, Mass.), 2017-09, Vol.18 (9), p.1695-1705</ispartof><rights>2016 American Academy of Pain Medicine. 2016</rights><rights>2016 American Academy of Pain Medicine.</rights><rights>Copyright © 2016 American Academy of Pain Medicine</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c458t-4b4f971786e82cced0939a60cc69c6cbc2169ee0d230a724c16cc406f261c0563</citedby><cites>FETCH-LOGICAL-c458t-4b4f971786e82cced0939a60cc69c6cbc2169ee0d230a724c16cc406f261c0563</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,777,781,882,1579,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27651510$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Webster, Lynn R.</creatorcontrib><creatorcontrib>Smith, Michael D.</creatorcontrib><creatorcontrib>Lawler, John</creatorcontrib><creatorcontrib>Lindhardt, Karsten</creatorcontrib><creatorcontrib>Dayno, Jeffrey M.</creatorcontrib><title>Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (Morphine-ADER Injection-Molded Tablets) vs Extended-Release Morphine Administered Intranasally in Nondependent Recreational Opioid Users</title><title>Pain medicine (Malden, Mass.)</title><addtitle>Pain Med</addtitle><description>Abstract
Objective. To compare the relative human abuse potential after insufflation of manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine ER tablets.
Methods. A randomized, double-blind, double-dummy, active- and placebo-controlled five-way crossover study was performed with adult volunteers who were experienced, nondependent, recreational opioid users. After intranasal (IN) administration of manipulated high-volume (HV) morphine-ADER-IMT (60 mg), participants were randomized (1:1:1:1) to receive IN manipulated low-volume (LV) morphine ER (60 mg), IN manipulated LV morphine-ADER-IMT, intact oral morphine-ADER-IMT (60 mg), and placebo in crossover fashion. Pharmacodynamic and pharmacokinetic assessments included peak effect of drug liking (Emax; primary endpoint) using drug liking visual analog scale (VAS) score, Emax using overall drug liking, and take drug again (TDA) VASs scores, and mean abuse quotient (AQ), a pharmacokinetic parameter associated with drug liking.
Results. Forty-six participants completed the study. After insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT, drug liking Emax was significantly lower (P < 0.0001) compared with IN morphine ER. Overall drug liking and TDA Emax values were significantly lower (P < 0.0001) after insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT compared with IN morphine ER. Mean AQ was lower after insufflation of HV (9.2) and LV (2.3) morphine-ADER-IMT or ingestion of oral morphine-ADER-IMT (5.5) compared with insufflation of LV morphine ER (37.2).
Conclusions. All drug liking, take drug again, and abuse quotient endpoints support a significantly lower abuse potential with insufflation of manipulated morphine-ADER-IMT compared with manipulated and insufflated non-AD ER morphine.</description><subject>Abuse-Deterrent Formulations - methods</subject><subject>Administration, Intranasal</subject><subject>Administration, Oral</subject><subject>Adult</subject><subject>Analgesics, Opioid - administration & dosage</subject><subject>Analgesics, Opioid - pharmacokinetics</subject><subject>Cross-Over Studies</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Delayed-Action Preparations - pharmacokinetics</subject><subject>Double-Blind Method</subject><subject>Drug abuse</subject><subject>Female</subject><subject>Humans</subject><subject>Injection</subject><subject>Male</subject><subject>Morphine</subject><subject>Morphine - administration & dosage</subject><subject>Morphine - pharmacokinetics</subject><subject>Narcotics</subject><subject>Opioid-Related Disorders - prevention & control</subject><subject>Opioids</subject><subject>OPIOIDS & SUBSTANCE USE DISORDERS SECTION</subject><subject>Pharmacodynamics</subject><subject>Tablets</subject><issn>1526-2375</issn><issn>1526-4637</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9Ut2K1DAULqK46-qFLyABvdgB6yZpm05vhDIzugO7rgy71yFNTt0MbVKTdHXf2YcwZX5QBK8S8v2ecJLkNcEfCK6yi6G_GMwPSqonySkpKEtzlpVP93ealcVJ8sL7LcaE5fPseXJCS1aQguDT5Nfl2AuD6mb0gL7aACZo0SHbosNruoQAzkUAndfL2Xu0-hlZClS6gQ5ElJ2vNjN0bd1wr000cVaNMqCFMEorESJ-wNJ6udqgtdmCDNqa9Np20QfdiqaD4Gfowf9rfvStVa-N9rFLlKxNcMIIL7ruEWmDvtgoGiZlrLkB6UBMCXGSm0FbrdCdB-dfJs9a0Xl4tT_PkrtPq9vFZXp183m9qK9SmRfzkOZN3lYlKecM5lRKUPGPK8GwlKySTDaSElYBYEUzLEqaS8KkzDFrKSMSFyw7Sz7ufIex6UFJmNp2fHC6F-6RW6H534jR9_ybfeBFDJpnOBq83Rs4-30EH_jWji6O4zkltKRFQbMpZrZjSWe9d9AeEwjm02Lwoee7xYjcN39WOjIPmxAJ73YEOw7_8fkNi-TFBg</recordid><startdate>20170901</startdate><enddate>20170901</enddate><creator>Webster, Lynn R.</creator><creator>Smith, Michael D.</creator><creator>Lawler, John</creator><creator>Lindhardt, Karsten</creator><creator>Dayno, Jeffrey M.</creator><general>Oxford University Press</general><scope>TOX</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>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>5PM</scope></search><sort><creationdate>20170901</creationdate><title>Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (Morphine-ADER Injection-Molded Tablets) vs Extended-Release Morphine Administered Intranasally in Nondependent Recreational Opioid Users</title><author>Webster, Lynn R. ; Smith, Michael D. ; Lawler, John ; Lindhardt, Karsten ; Dayno, Jeffrey M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c458t-4b4f971786e82cced0939a60cc69c6cbc2169ee0d230a724c16cc406f261c0563</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Abuse-Deterrent Formulations - methods</topic><topic>Administration, Intranasal</topic><topic>Administration, Oral</topic><topic>Adult</topic><topic>Analgesics, Opioid - administration & dosage</topic><topic>Analgesics, Opioid - pharmacokinetics</topic><topic>Cross-Over Studies</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Delayed-Action Preparations - pharmacokinetics</topic><topic>Double-Blind Method</topic><topic>Drug abuse</topic><topic>Female</topic><topic>Humans</topic><topic>Injection</topic><topic>Male</topic><topic>Morphine</topic><topic>Morphine - administration & dosage</topic><topic>Morphine - pharmacokinetics</topic><topic>Narcotics</topic><topic>Opioid-Related Disorders - prevention & control</topic><topic>Opioids</topic><topic>OPIOIDS & SUBSTANCE USE DISORDERS SECTION</topic><topic>Pharmacodynamics</topic><topic>Tablets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Webster, Lynn R.</creatorcontrib><creatorcontrib>Smith, Michael D.</creatorcontrib><creatorcontrib>Lawler, John</creatorcontrib><creatorcontrib>Lindhardt, Karsten</creatorcontrib><creatorcontrib>Dayno, Jeffrey M.</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pain medicine (Malden, Mass.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Webster, Lynn R.</au><au>Smith, Michael D.</au><au>Lawler, John</au><au>Lindhardt, Karsten</au><au>Dayno, Jeffrey M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (Morphine-ADER Injection-Molded Tablets) vs Extended-Release Morphine Administered Intranasally in Nondependent Recreational Opioid Users</atitle><jtitle>Pain medicine (Malden, Mass.)</jtitle><addtitle>Pain Med</addtitle><date>2017-09-01</date><risdate>2017</risdate><volume>18</volume><issue>9</issue><spage>1695</spage><epage>1705</epage><pages>1695-1705</pages><issn>1526-2375</issn><eissn>1526-4637</eissn><abstract>Abstract
Objective. To compare the relative human abuse potential after insufflation of manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine ER tablets.
Methods. A randomized, double-blind, double-dummy, active- and placebo-controlled five-way crossover study was performed with adult volunteers who were experienced, nondependent, recreational opioid users. After intranasal (IN) administration of manipulated high-volume (HV) morphine-ADER-IMT (60 mg), participants were randomized (1:1:1:1) to receive IN manipulated low-volume (LV) morphine ER (60 mg), IN manipulated LV morphine-ADER-IMT, intact oral morphine-ADER-IMT (60 mg), and placebo in crossover fashion. Pharmacodynamic and pharmacokinetic assessments included peak effect of drug liking (Emax; primary endpoint) using drug liking visual analog scale (VAS) score, Emax using overall drug liking, and take drug again (TDA) VASs scores, and mean abuse quotient (AQ), a pharmacokinetic parameter associated with drug liking.
Results. Forty-six participants completed the study. After insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT, drug liking Emax was significantly lower (P < 0.0001) compared with IN morphine ER. Overall drug liking and TDA Emax values were significantly lower (P < 0.0001) after insufflation of HV morphine-ADER-IMT and LV morphine-ADER-IMT compared with IN morphine ER. Mean AQ was lower after insufflation of HV (9.2) and LV (2.3) morphine-ADER-IMT or ingestion of oral morphine-ADER-IMT (5.5) compared with insufflation of LV morphine ER (37.2).
Conclusions. All drug liking, take drug again, and abuse quotient endpoints support a significantly lower abuse potential with insufflation of manipulated morphine-ADER-IMT compared with manipulated and insufflated non-AD ER morphine.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>27651510</pmid><doi>10.1093/pm/pnw219</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Abuse-Deterrent Formulations - methods Administration, Intranasal Administration, Oral Adult Analgesics, Opioid - administration & dosage Analgesics, Opioid - pharmacokinetics Cross-Over Studies Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - pharmacokinetics Double-Blind Method Drug abuse Female Humans Injection Male Morphine Morphine - administration & dosage Morphine - pharmacokinetics Narcotics Opioid-Related Disorders - prevention & control Opioids OPIOIDS & SUBSTANCE USE DISORDERS SECTION Pharmacodynamics Tablets |
| title | Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (Morphine-ADER Injection-Molded Tablets) vs Extended-Release Morphine Administered Intranasally in Nondependent Recreational Opioid Users |
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