Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone
海洛因成瘾者对艾滋病毒治疗的依从性:口服纳曲酮与缓释纳曲酮
基本信息
- 批准号:8288300
- 负责人:
- 金额:$ 38.28万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2009
- 资助国家:美国
- 起止时间:2009-09-18 至 2015-06-30
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAgonistAlcohol or Other Drugs useAppointments and SchedulesBehaviorBuprenorphineCD4 Lymphocyte CountCounselingDevelopmentDiseaseDouble-Blind MethodDrug FormulationsDrug Metabolic DetoxicationDrug usageHIVHIV therapyHeroinHeroin DependenceImplantLawsLeadMaintenanceMaintenance TherapyMeasuresMediatingMedicalMethadoneMethodsNaltrexoneObsessive compulsive behaviorOpiate AddictionOpioidOralPatientsPharmaceutical PreparationsPlacebosPlasmaRandomizedRelapseResearchResistanceRisk BehaviorsRussiaScienceSymptomsTabletsTestingTimeTreatment FailureTreatment outcomeUniversitiesUrineViral Load resultWorkaddictionantiretroviral therapycomparative efficacydrug seeking behaviorexperiencehigh risk behaviorimprovedinterestmeetingspreventprimary outcomeprogramsresponsesecondary outcometherapy adherencetreatment responsetrial comparingviral resistance
项目摘要
Relapse to opioid addiction in patients with HIV contributes to drug-seeking behavior, non-adherence to
antiretroviral therapy (ART), treatment failure, and the development of viral resistance. Successful addiction
treatment should do the opposite. Opioid addicted patients receiving ART are often maintained on methadone
or buprenorphine, but these medications are subject to regulatory limitations, do not always stop opioid use,
are not available in many settings, and not acceptable to all patients.
Naltrexone maintenance is another option that could be useful as it blocks opioid effects and prevents
relapse if taken as directed. It has been available as a 50 mg tablet that is taken daily and was initially met
with enthusiasm by clinicians; however enthusiasm waned when most patients stopped taking it and relapsed.
Efforts to develop long-acting formulations that might overcome these problems were realized only very
recently, and sustained release formulations are now available and have renewed interest in using it for opioid
addiction treatment. These formulations may also facilitate adherence to ART in opioid addicted patients by
preventing relapse. Accordingly, this project aims to test whether an implantable formulation that slowly
releases naltrexone and blocks opioid effects for 3 months (IN) is more effective than 50 mg/day oral
naltrexone (ON) for improving ART adherence and treatment outcome in opioid addicted patients who are
beginning their first episode of ART.
Russia is an ideal place to study IN since it has an approved product, most HIV patients are heroin addicts,
Russian law does not permit agonist treatment, patient interest in naltrexone is high, and the collaborating
research team at Pavlov Medical University has extensive experience with IN and ON. To test the hypothesis that
IN results in better HIV treatment outcome than ON, we propose a 48-week, randomized, double blind, double-
dummy trial comparing IN with ON in 200 recently detoxified heroin addicts beginning their first episode of ART in
St. Petersburg. The primary outcomes will be the proportion of patients with a viral load of <400 copies at 24 and
48 weeks. We hypothesize that IN will work better than ON because it will be associated with less relapse and
more adherence.
HIV患者阿片类药物成瘾的复发有助于寻求药物的行为,
抗逆转录病毒治疗(ART),治疗失败,以及病毒耐药性的发展。成功成瘾
治疗应该做相反的事情。接受抗逆转录病毒疗法的阿片类药物成瘾患者通常维持美沙酮治疗
或丁丙诺啡,但这些药物受到监管限制,并不总是停止阿片类药物的使用,
在许多情况下是不可用的,并且不是所有患者都能接受的。
纳洛酮维持是另一种可能有用的选择,因为它可以阻断阿片类药物的作用,
如果按照指示服用,复发。它已作为一个50毫克的片剂,每天服用,最初是满足
临床医生的热情;然而,当大多数患者停止服用并复发时,热情减弱。
开发可能克服这些问题的长效制剂的努力只是在很短的时间内才实现。
最近,持续释放制剂现在是可用的,并且重新引起了将其用于阿片样物质的兴趣。
戒毒治疗这些制剂还可以通过以下方式促进阿片类药物成瘾患者对ART的依从性:
防止复发。因此,该项目旨在测试一种植入式制剂,
释放纳洛酮并阻断阿片类药物作用3个月(IN)比50 mg/天口服更有效
纳洛酮(ON)用于改善阿片类药物成瘾患者的ART依从性和治疗结果,
开始他们的第一集艺术。
俄罗斯是研究IN的理想场所,因为它有一个批准的产品,大多数艾滋病毒患者是海洛因成瘾者,
俄罗斯法律不允许激动剂治疗,患者对纳洛酮的兴趣很高,
巴甫洛夫医科大学的一个研究小组在IN和ON方面有着丰富的经验。为了验证这一假设,
IN的艾滋病毒治疗结果比ON更好,我们建议进行一项为期48周的、随机、双盲、双盲研究,
在200名最近戒毒的海洛因成瘾者中进行了比较IN和ON的模拟试验,
圣彼得堡。主要结果将是24岁时病毒载量<400拷贝的患者比例,
48周我们假设IN比ON效果更好,因为它与较少的复发相关,
更多的坚持。
项目成果
期刊论文数量(2)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Depression, substance use, viral load, and CD4+ count among patients who continued or left antiretroviral therapy for HIV in St. Petersburg, Russian Federation.
俄罗斯联邦圣彼得堡继续或停止接受 HIV 抗逆转录病毒治疗的患者的抑郁、物质使用、病毒载量和 CD4 计数。
- DOI:10.1080/09540121.2014.959464
- 发表时间:2015
- 期刊:
- 影响因子:1.7
- 作者:Pecoraro,Anna;Mimiaga,Matthew;O'Cleirigh,Conall;Safren,StevenA;Blokhina,Elena;Verbitskaya,Elena;Yaroslavtseva,Tatiana;Ustinov,Andrey;Lioznov,DmitryA;Zvartau,Edwin;Krupitsky,Evgeny;Woody,GeorgeE
- 通讯作者:Woody,GeorgeE
Proactive coping and spirituality among patients who left or remained in antiretroviral treatment in St Petersburg, Russian Federation.
俄罗斯联邦圣彼得堡离开或继续接受抗逆转录病毒治疗的患者的积极应对和灵性。
- DOI:10.1080/09540121.2015.1096895
- 发表时间:2016
- 期刊:
- 影响因子:1.7
- 作者:Pecoraro,Anna;Pacciolla,Aureliano;O'Cleirigh,Conall;Mimiaga,Matthew;Kwiatek,Piotr;Blokhina,Elena;Verbitskaya,Elena;Krupitsky,Evgeny;Woody,GeorgeE
- 通讯作者:Woody,GeorgeE
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GEORGE Edward WOODY其他文献
GEORGE Edward WOODY的其他文献
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{{ truncateString('GEORGE Edward WOODY', 18)}}的其他基金
Opioid Relaps & HIV Risk: 48 vs. 24 Weeks of ER Injectable Naltrexone
阿片类药物复发
- 批准号:
8717625 - 财政年份:2012
- 资助金额:
$ 38.28万 - 项目类别:
Opioid Relaps & HIV Risk: 48 vs. 24 Weeks of ER Injectable Naltrexone
阿片类药物复发
- 批准号:
8519398 - 财政年份:2012
- 资助金额:
$ 38.28万 - 项目类别:
Opioid Relaps & HIV Risk: 48 vs. 24 Weeks of ER Injectable Naltrexone
阿片类药物复发
- 批准号:
9116813 - 财政年份:2012
- 资助金额:
$ 38.28万 - 项目类别:
Opioid Relaps & HIV Risk: 48 vs. 24 Weeks of ER Injectable Naltrexone
阿片类药物复发
- 批准号:
8310620 - 财政年份:2012
- 资助金额:
$ 38.28万 - 项目类别:
Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone
海洛因成瘾者对艾滋病毒治疗的依从性:口服纳曲酮与缓释纳曲酮
- 批准号:
7756239 - 财政年份:2009
- 资助金额:
$ 38.28万 - 项目类别:
Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors
Suboxone 和美沙酮可降低 Subutex 注射器中的 HIV 风险
- 批准号:
7684519 - 财政年份:2009
- 资助金额:
$ 38.28万 - 项目类别:
Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone
海洛因成瘾者对艾滋病毒治疗的依从性:口服纳曲酮与缓释纳曲酮
- 批准号:
8143927 - 财政年份:2009
- 资助金额:
$ 38.28万 - 项目类别:
Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone
海洛因成瘾者对艾滋病毒治疗的依从性:口服纳曲酮与缓释纳曲酮
- 批准号:
8092869 - 财政年份:2009
- 资助金额:
$ 38.28万 - 项目类别:
Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone
海洛因成瘾者对艾滋病毒治疗的依从性:口服纳曲酮与缓释纳曲酮
- 批准号:
8298404 - 财政年份:2009
- 资助金额:
$ 38.28万 - 项目类别:
Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone
海洛因成瘾者对艾滋病毒治疗的依从性:口服纳曲酮与缓释纳曲酮
- 批准号:
7934539 - 财政年份:2009
- 资助金额:
$ 38.28万 - 项目类别:
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