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临床试验/NCT04024059
NCT04024059已完成不适用

Contingency Management to Enhance Office-Based Buprenorphine Treatment

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2020年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
375
试验地点
2
主要终点
Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples

研究概览

简要总结

Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period.

详细描述

Opioid use has increased to epidemic levels in the United States and has been associated with a dramatic increase in overdose deaths. Buprenorphine is a safe, well-tolerated, and evidence-based medication for opioid use disorder that can be prescribed in office-based treatment settings. Office-based buprenorphine could be an effective way to expand treatment for opioid use disorder, and thereby combat the opioid epidemic. However, office-based buprenorphine has three limitations that must be addressed to facilitate the safe and effective expansion of buprenorphine treatment: 1) Many patients discontinue buprenorphine treatment prematurely, 2) some patients divert buprenorphine for illicit use, and 3) many patients continue to use illicit opioids during buprenorphine treatment. This project will address these limitations by using a psychosocial approach known as Contingency Management. Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period. If the proposed intervention is effective, it could encourage medical professionals to prescribe buprenorphine, and improve patients' access to and success in office-based buprenorphine treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Opioid use disorder
  • Enrolled in buprenorphine treatment

排除标准

  • Unwilling or unable to use a smartphone

结局指标

主要结局

Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples

时间窗: 12 weeks

This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.

Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples

时间窗: 12 weeks

This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.

次要结局

  • Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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