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临床试验/NCT03678792
NCT03678792撤回3 期

Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals

University of Alabama at Birmingham1 个研究点 分布在 1 个国家开始时间: 2019年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
试验地点
1
主要终点
Time to detoxification regimen completion

研究概览

简要总结

Despite an increased focus on treating opioid use disorder there are relatively few studies that compare the length of time required for detoxification with medications other than buprenorphine. Morphine and tramadol have shorter half-lives than buprenorphine and can be used for opioid detoxification. The proposed protocol aims to address this gap by directly comparing the length of treatment required for detoxification from opioids in a patient-centered manner with oral morphine, tramadol, or buprenorphine-naloxone as well as comparing the severity of withdrawal experienced by patients in each group. The investigators predict that treatment with oral morphine or tramadol will result in a faster completion of detoxification and initiation of naltrexone maintenance.

详细描述

Opioid dependent individuals will be recruited for participation in the study. Upon recruitment into the randomized trial each participant will be started on an induction dosage of medication intended to suppress withdrawal (either buprenorphine-naloxone, morphine, or tramadol). Participants will remain on the induction dose for at least 24 hrs. Severity of withdrawal will be assessed twice a day using the Clinical Opiate Withdrawal Scale (COWS) and the Subjective Opiate Withdrawal Scale (SOWS). Each morning, participants will be given the option to progress on the tapering protocol (see below for individual regimens). Time to complete detoxification and initiation of naltrexone treatment will be measured. At completion of the study each participant will complete a 7-iten Detoxification Treatment Satisfaction questionnaire.

Taper Schedule Dosing Buprenorphine-Naloxone (Suboxone): Patients will get 4mg when withdrawal symptoms start. Patients can receive the first 8mg dose as early as 6hrs later, and at that point will start on an 8mg twice-a-day schedule. Each morning the patient will be assessed regarding their ability to progress to the next stage of the taper. Buprenorphine-naloxone will be tapered 2mg/day.

Tramadol: At enrollment the patients will receive a 100mg dose and can receive another 100mg every 6 hrs for 24 hrs. Each morning the patient will be assessed regarding their ability to progress to the next stage of the taper. Patients will then be tapered on the following schedule 100mg every 8 hrs, 50mg every 6 hrs, 50mg every 8 hrs, 50mg ever 12 hrs, and one final daily dose of 50mg.

Morphine: Patients receive 30mg every 4 hours for 24 hrs from when withdrawal symptoms start. Each morning the patient will be assessed regarding their ability to progress to the next stage of the taper. Patients will then be tapered on the following schedule: 30 mg every 6 hours, 30 mg every 8 hours, 30 mg every 12 hours, and one final daily 30 mg dose.

As Needed Medications: Patients in all groups will have access to the following medications as needed gabapentin 400mg every 8 hrs, loperamide 2mg every 3 hrs, odansetron 4mg every 6 hrs, ibuprofen 600mg ever 8 hrs, and hydroxyzine 25-50mg nightly.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
治疗
盲法
开放(无盲法)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • 18-65 years of age
  • Meeting DSM-V criteria for opioid use disorder
  • Current use of opiates
  • Displaying evidence of opioid withdrawal
  • Having no significant current medical/psychiatric illness
  • English speaking

排除标准

  • Use of methadone or buprenorphine exclusively
  • Pregnancy
  • Hypotensive
  • History of seizures
  • Physical dependence on alcohol and/or benzodiazepines that requires treatment

研究组 & 干预措施

Buprenorphine-Naloxone

Other

Standard of Care

干预措施: Buprenorphine/naloxone (Drug)

Morphine

Experimental

干预措施: Morphine (Drug)

Tramadol

Experimental

干预措施: Tramadol (Drug)

结局指标

主要结局

Time to detoxification regimen completion

时间窗: Five to twenty days

Will be measured from first to last dose of tapering medication

Time to naltrexone test dose

时间窗: 12 to 30 days

Measured from first dose of tapering medication to naltrexone test dose

次要结局

  • Subjective Opiate Withdrawal Scale(Five to twenty days)
  • Clinical Opiate Withdrawal Scale(Five to twenty days)
  • Total use of 'as needed medications' during detoxification(Five to twenty days)
  • Treatment Satisfaction Survey(One day)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Karen Cropsey

Principle Investigator

University of Alabama at Birmingham

研究点 (1)

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标识符

NCT 编号
NCT03678792
其他研究编号
IRB-300001612

日期

首次提交
(8年前)
首次发布
(8年前)
主要完成日期
研究完成日期
(5年前)
最近核实
最近更新
(6年前)

监管与共享

FDA 监管药物
是
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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