NCT01882361已完成2 期
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Opiate positive urine tests
研究概览
简要总结
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
详细描述
1.2.1 Primary and Secondary Outcome Measures
Primary outcomes are:
- Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
- Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-negative men and women 18 years of age or older who meet the Diagnostic and Statistical Manual of Mental Disorders 4th edition-Text Revision (DSM- IV-TR) criteria for opioid dependence
- •Must be voluntarily seeking treatment for opioid dependence, with injection heroin as the drug and administration route of choice
- •Must report sharing injection equipment during the past year
- •Must have successfully completed inpatient detoxification at the Federal Medical Research Center for Psychiatry and Narcology (FMRCPN)
- •Must have no current evidence of physiologic dependence
- •Must have a stable address in Moscow with a telephone number where they can be reached
- •If female, must have a negative pregnancy test and use of medically acceptable contraception if of childbearing age
- •Must be able to provide informed consent as judged by the ability to read the consent and correctly answer 9 out of 10 questions about the study on a quiz
排除标准
- •No current condition of psychosis (schizophrenia,paranoid disorder, mania)
- •No history of major psychiatric disorders such as Schizophrenia, Major Depression with suicidal attempts, Bipolar I, uncontrolled epilepsy or other seizure disorder
- •No current dependence (within the past year) to drugs other than prescription opiates or heroin, caffeine, marijuana, or nicotine based on the Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM -IV-TR) criteria
- •No current alcohol dependence or alcohol use disorder that would preclude successful completion of study procedures
- •No current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
- •No cognitive impairment with inability to read and understand the consent
- •No significant laboratory abnormality such as haemoglobin <10, hepatic transaminase levels >3 times upper limit of normal or serum creatinine that is >1.5 times upper limit of normal
- •No legal charges with impending incarceration
- •No concurrent participation in another treatment study
- •Cannot be scheduled for surgery or be likely to require opioids for pain control in next 2 years
- •Not currently taking naltrexone or currently receiving other treatment (pharmacological or behavioral) for drug dependence or currently receiving psychoactive medication
- •Cannot have had receipt of any approved or investigational depot product administered into the gluteal muscle within 6 months before screening
- •Cannot be on any excluded medication at screening or be anticipating the use of an excluded medication during the study period
- •Cannot have participated in a clinical trial of a pharmacological agent within 30 days prior to screening
研究组 & 干预措施
injectable naltrexone
Active Comparator
One dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial.
干预措施: injectable naltrexone (Drug)
placebo injection for naltrexone
Placebo Comparator
placebo comparator injection starting at week 24 in a 48-week trial.
干预措施: placebo comparator (Drug)
结局指标
主要结局
Opiate positive urine tests
时间窗: 12 months
Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition
次要结局
- HIV sex risk(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at BirthHIV InfectionsNCT00102960National Institute of Allergy and Infectious Diseases (NIAID)377
已完成
3 期
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken ZidovudineHIV InfectionsNCT00002371Bristol-Myers Squibb80
已完成
不适用
A Study to Compare the Effectiveness of Two Anti-HIV Drug CombinationsHIV InfectionsNCT00002430Merck Sharp & Dohme LLC220
Unknown
3 期
Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis TreatmentHuman Immunodeficiency Virus InfectionsTuberculosisNCT00332306Tuberculosis Research Centre, India180
已完成
不适用
Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study ParticipantsHIV InfectionsNCT00386035National Institute of Allergy and Infectious Diseases (NIAID)883