A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of methamphetamine dependence
Methamphetamine dependence is an increasing public health problem in the United States. No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the...
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description | Methamphetamine dependence is an increasing public health problem in the United States. No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the rewarding effects of d-amphetamine in animal and human laboratory studies, we decided to test whether it would be superior to placebo at reducing methamphetamine use. In a preliminary, multi-site, randomized, double-blind, 8-wk controlled trial, 150 methamphetamine-dependent men and women received ondansetron (0.25 mg, 1 mg, or 4 mg b.i.d.) or placebo. Participants were assessed on several measures of methamphetamine use including urine methamphetamine level up to three times per week. As a psychosocial adjunct to the medication condition, cognitive behavioural therapy also was administered three times per week. Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events. Nevertheless, none of the ondansetron doses was superior to placebo at decreasing any of the measures of methamphetamine use, withdrawal, craving, or clinical severity of methamphetamine dependence. Our preliminary results do not support the utility of ondansetron, at the doses tested, as a treatment for methamphetamine dependence. These findings should be viewed in light of the possibility that a less intensive cognitive behavioural therapy regimen might have yielded more positive results in this initial phase II trial exploring for the efficacy of ondansetron. |
doi_str_mv | 10.1017/S1461145707007778 |
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No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the rewarding effects of d-amphetamine in animal and human laboratory studies, we decided to test whether it would be superior to placebo at reducing methamphetamine use. In a preliminary, multi-site, randomized, double-blind, 8-wk controlled trial, 150 methamphetamine-dependent men and women received ondansetron (0.25 mg, 1 mg, or 4 mg b.i.d.) or placebo. Participants were assessed on several measures of methamphetamine use including urine methamphetamine level up to three times per week. As a psychosocial adjunct to the medication condition, cognitive behavioural therapy also was administered three times per week. Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events. Nevertheless, none of the ondansetron doses was superior to placebo at decreasing any of the measures of methamphetamine use, withdrawal, craving, or clinical severity of methamphetamine dependence. Our preliminary results do not support the utility of ondansetron, at the doses tested, as a treatment for methamphetamine dependence. These findings should be viewed in light of the possibility that a less intensive cognitive behavioural therapy regimen might have yielded more positive results in this initial phase II trial exploring for the efficacy of ondansetron.</description><identifier>ISSN: 1461-1457</identifier><identifier>EISSN: 1469-5111</identifier><identifier>DOI: 10.1017/S1461145707007778</identifier><identifier>PMID: 17470315</identifier><language>eng</language><publisher>Cambridge, UK: Cambridge University Press</publisher><subject>Adolescent ; Adult ; Amphetamine-Related Disorders - drug therapy ; Amphetamine-Related Disorders - psychology ; Amphetamine-Related Disorders - therapy ; Central Nervous System Stimulants - urine ; Cognitive Therapy ; Combined Modality Therapy ; Data analysis ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug abuse ; Drug use ; Female ; Health services ; Humans ; Male ; Methamphetamine ; Methamphetamine - urine ; Ondansetron - adverse effects ; Ondansetron - therapeutic use ; Physical examinations ; Psychiatric Status Rating Scales ; Sample size ; Serotonin Antagonists - adverse effects ; Serotonin Antagonists - therapeutic use ; Substance Abuse Detection ; Substance abuse treatment ; Treatment Outcome</subject><ispartof>The international journal of neuropsychopharmacology, 2008-02, Vol.11 (1), p.1-14</ispartof><rights>Copyright © Collegium Internationale Neuropsychopharmacologicum 2007</rights><rights>Copyright Cambridge University Press Feb 2008</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-b40360d5ede444cd260b5f62981ca5176dff6f19e942f83b7b99d53740338cf03</citedby><cites>FETCH-LOGICAL-c413t-b40360d5ede444cd260b5f62981ca5176dff6f19e942f83b7b99d53740338cf03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17470315$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Johnson, Bankole A.</creatorcontrib><creatorcontrib>Ait-Daoud, Nassima</creatorcontrib><creatorcontrib>Elkashef, Ahmed M.</creatorcontrib><creatorcontrib>Smith, Edwina V.</creatorcontrib><creatorcontrib>Kahn, Roberta</creatorcontrib><creatorcontrib>Vocci, Francis</creatorcontrib><creatorcontrib>Li, Shou-Hua</creatorcontrib><creatorcontrib>Bloch, Daniel A.</creatorcontrib><creatorcontrib>Methamphetamine Study Group</creatorcontrib><creatorcontrib>the Methamphetamine Study Group</creatorcontrib><title>A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of methamphetamine dependence</title><title>The international journal of neuropsychopharmacology</title><addtitle>Int J Neuropsychopharmacol</addtitle><description>Methamphetamine dependence is an increasing public health problem in the United States. No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the rewarding effects of d-amphetamine in animal and human laboratory studies, we decided to test whether it would be superior to placebo at reducing methamphetamine use. In a preliminary, multi-site, randomized, double-blind, 8-wk controlled trial, 150 methamphetamine-dependent men and women received ondansetron (0.25 mg, 1 mg, or 4 mg b.i.d.) or placebo. Participants were assessed on several measures of methamphetamine use including urine methamphetamine level up to three times per week. As a psychosocial adjunct to the medication condition, cognitive behavioural therapy also was administered three times per week. Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events. Nevertheless, none of the ondansetron doses was superior to placebo at decreasing any of the measures of methamphetamine use, withdrawal, craving, or clinical severity of methamphetamine dependence. Our preliminary results do not support the utility of ondansetron, at the doses tested, as a treatment for methamphetamine dependence. These findings should be viewed in light of the possibility that a less intensive cognitive behavioural therapy regimen might have yielded more positive results in this initial phase II trial exploring for the efficacy of ondansetron.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Amphetamine-Related Disorders - drug therapy</subject><subject>Amphetamine-Related Disorders - psychology</subject><subject>Amphetamine-Related Disorders - therapy</subject><subject>Central Nervous System Stimulants - urine</subject><subject>Cognitive Therapy</subject><subject>Combined Modality Therapy</subject><subject>Data analysis</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug abuse</subject><subject>Drug use</subject><subject>Female</subject><subject>Health services</subject><subject>Humans</subject><subject>Male</subject><subject>Methamphetamine</subject><subject>Methamphetamine - urine</subject><subject>Ondansetron - adverse effects</subject><subject>Ondansetron - therapeutic use</subject><subject>Physical examinations</subject><subject>Psychiatric Status Rating Scales</subject><subject>Sample size</subject><subject>Serotonin Antagonists - adverse effects</subject><subject>Serotonin Antagonists - therapeutic use</subject><subject>Substance Abuse Detection</subject><subject>Substance abuse treatment</subject><subject>Treatment Outcome</subject><issn>1461-1457</issn><issn>1469-5111</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kc1O3TAQhS1UVCjtA3RTWV2T1hM7cbJEiJ9KSCxK15F_xtygxE5tZ3F5k74tvpcrsahY2Z5zvjPWDCFfgf0ABvLnbxAtgGgkk4xJKbsjclpKfdUAwIf9HaqdfkI-pfTEWC0a3n4kJyCFZByaU_Lvgi4Rp3EevYpbGpW3YR6f0Z5TG1Y9YaWn0ZfXMimDOlQm-BzDNKGlKa92S4OjeYM0KYd5SwtP0bnRKLOXgrfKJyyIp6PfO3NElWf0eafPmDdqXjaYVfkCUosLeove4Gdy7NSU8MvhPCN_rq8eLm-ru_ubX5cXd5URwHOlBeMtsw1aFEIYW7dMN66t-w6MakC21rnWQY-9qF3HtdR9bxsuC8Y74xg_I99fc5cY_q6Y8vAU1uhLy6Gua97VkvXFBK8mE0NKEd2wxHEuExuADbtdDP_tojDfDsGrntG-EYfhFwM_hKpZx9E-4lvr92NfADLQlfY</recordid><startdate>20080201</startdate><enddate>20080201</enddate><creator>Johnson, Bankole A.</creator><creator>Ait-Daoud, Nassima</creator><creator>Elkashef, Ahmed M.</creator><creator>Smith, Edwina V.</creator><creator>Kahn, Roberta</creator><creator>Vocci, Francis</creator><creator>Li, Shou-Hua</creator><creator>Bloch, Daniel A.</creator><general>Cambridge University Press</general><general>Oxford University Press</general><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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</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>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope></search><sort><creationdate>20080201</creationdate><title>A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of methamphetamine dependence</title><author>Johnson, Bankole A. ; Ait-Daoud, Nassima ; Elkashef, Ahmed M. ; Smith, Edwina V. ; Kahn, Roberta ; Vocci, Francis ; Li, Shou-Hua ; Bloch, Daniel A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-b40360d5ede444cd260b5f62981ca5176dff6f19e942f83b7b99d53740338cf03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Amphetamine-Related Disorders - 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No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the rewarding effects of d-amphetamine in animal and human laboratory studies, we decided to test whether it would be superior to placebo at reducing methamphetamine use. In a preliminary, multi-site, randomized, double-blind, 8-wk controlled trial, 150 methamphetamine-dependent men and women received ondansetron (0.25 mg, 1 mg, or 4 mg b.i.d.) or placebo. Participants were assessed on several measures of methamphetamine use including urine methamphetamine level up to three times per week. As a psychosocial adjunct to the medication condition, cognitive behavioural therapy also was administered three times per week. Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events. Nevertheless, none of the ondansetron doses was superior to placebo at decreasing any of the measures of methamphetamine use, withdrawal, craving, or clinical severity of methamphetamine dependence. Our preliminary results do not support the utility of ondansetron, at the doses tested, as a treatment for methamphetamine dependence. These findings should be viewed in light of the possibility that a less intensive cognitive behavioural therapy regimen might have yielded more positive results in this initial phase II trial exploring for the efficacy of ondansetron.</abstract><cop>Cambridge, UK</cop><pub>Cambridge University Press</pub><pmid>17470315</pmid><doi>10.1017/S1461145707007778</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adolescent Adult Amphetamine-Related Disorders - drug therapy Amphetamine-Related Disorders - psychology Amphetamine-Related Disorders - therapy Central Nervous System Stimulants - urine Cognitive Therapy Combined Modality Therapy Data analysis Dose-Response Relationship, Drug Double-Blind Method Drug abuse Drug use Female Health services Humans Male Methamphetamine Methamphetamine - urine Ondansetron - adverse effects Ondansetron - therapeutic use Physical examinations Psychiatric Status Rating Scales Sample size Serotonin Antagonists - adverse effects Serotonin Antagonists - therapeutic use Substance Abuse Detection Substance abuse treatment Treatment Outcome |
title | A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of methamphetamine dependence |
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