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临床试验/NCT01632982
NCT01632982Unknown不适用

Providing Psychosocial Interventions to Substance Abusers Via Mobile Technology

National Development and Research Institutes, Inc.2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
219
试验地点
2
主要终点
opioid use

研究概览

简要总结

This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention; and (3) a mobile-based control condition on the primary outcomes of treatment retention and opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.

详细描述

This study will develop and implement a mobile technology-delivered psychosocial intervention for opioid-dependent adults in methadone maintenance treatment (MMT). This novel therapeutic system promises to be cost-effective and to enable the provision of flexible, on-demand therapeutic support outside of the formal treatment setting. The specific aims of this investigation are as follows: Aim 1: The investigators will develop a novel, interactive, evidence-based psychosocial intervention delivered via mobile phones, designed to promote skills acquisition and reduce illicit drug use. Specifically, our Mobile Therapeutic System (MTS) will offer key elements of a psychosocial intervention for substance use disorders of known efficacy (the Community Reinforcement Approach). Participants will be provided with unlimited daily prompts to encourage use of the program and will be able to access the application at any time and as much as they choose, within their natural environments. Our iterative development process will include input from focus groups with clients in methadone treatment (n=24), input from experts in the field, and feedback testing of a beta-version of the mobile phone-based program with clients in methadone treatment (n=30). Aim 2: The investigators will evaluate the efficacy of this mobile tool with participants entering MMT during the first three months of their treatment (n=219). The investigators will evaluate the relative preliminary efficacy of (1) standard treatment, (2) standard treatment plus MTS and (3) a mobile-based control condition on the primary outcomes of retention and opioid use (via urine toxicology) and secondary outcomes of other substance use (via urine toxicology and self-report), readiness to change drug use behavior, coping skills, opioid craving, HIV risk behavior, and psychosocial functioning during the 3-month intervention phase. Durability of effects will be examined at 1 and 3 month follow-ups. Aim 3: The investigators will perform an economic analysis of MTS in community-based MMT. The investigators will estimate the incremental costs and the incremental cost-effectiveness ratio (ICER) of MTS relative to standard care and the mobile control group. The primary ICER will be the incremental costs per increased abstinence time (the clinical measure of effectiveness) and the secondary ICER will be incremental costs per increased quality adjusted life year (QALY) (the economic measure of effectiveness). Cost data will be vital to future translational projects to disseminate effective mobile interventions in community systems. If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.

研究设计

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

入排标准

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

入选标准

  • client enrolled in the study site's methadone maintenance program
  • within the first month of initiating methadone maintenance treatment
  • 18 years of age or older
  • sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone- delivered interventions

排除标准

  • entering treatment at the study site with the intention of receiving a methadone-assisted withdrawal only
  • evidence of an active psychiatric disorder requiring immediate intervention (e.g., suicidality, psychosis)
  • evidence of significant mental illness that may preclude participation

研究组 & 干预措施

standard treatment

Other

the standard drug counseling offered to patients in methadone maintenance treatment at the study site

干预措施: standard treatment (Behavioral)

Mobile Therapeutic System (MTS)

Experimental

The Mobile Therapeutic System (MTS) is a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment

干预措施: standard treatment (Behavioral)

Mobile Therapeutic System (MTS)

Experimental

The Mobile Therapeutic System (MTS) is a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment

干预措施: MTS (Mobile Therapeutic System) (Behavioral)

mobile control

Active Comparator

a mobile phone-based application that directs participants to the NIDA website's home page

干预措施: standard treatment (Behavioral)

mobile control

Active Comparator

a mobile phone-based application that directs participants to the NIDA website's home page

干预措施: mobile control (Behavioral)

结局指标

主要结局

opioid use

时间窗: 6 months

participants' illicit use of opioids, as measured by urine toxicology and self-report (self-report data collected via the timeline follow-back calendar assessment \[TLFB\])

treatment retention

时间窗: 6 months

participants' retention in methadone maintenance treatment (MMT)

次要结局

  • HIV risk behavior(6 months)
  • other substance use(6 months)
  • heroin/opioid craving(6 months)
  • psychiatric and psychosocial functioning(6 months)
  • coping skills(6 months)
  • readiness to change drug use(6 months)

研究者

发起方
National Development and Research Institutes, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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