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临床试验/NCT00292136
NCT00292136已完成不适用

Real Time Assessment of Drug Craving, Use, and Abstinence During Outpatient: A Development and Feasibility Study

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2003年8月15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
230
试验地点
1

研究概览

简要总结

Background:

  • The treatment of addiction often hinges on preventing relapse into drug-using behaviors, which occurs at high rates even after prolonged abstinence. Research has shown that constant reporting through personal data-collection devices, such as electronic diaries, can help prevent relapse and reinforce abstinence. This constant reporting is known as Ecological Momentary Assessment (EMA).
  • The researchers here at NIDA have already completed two major arms of the study, focusing on patterns of craving and drug use during methadone maintenance, and on whether electronic diaries could help remind outpatients to complete treatment tasks. An ongoing arm of the study is examining connections among drug craving/use, stress, and geographical location.

Objective:

  • To investigate the role of stress associated with geographical location in drug craving and use.

Eligibility:

  • Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine and/or heroin).

Design:

  • The study will last 28 weeks. After the initial screening, participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study.
  • After 3 weeks of methadone treatment, participants will have 15 weeks of EMA in which they will record both event-triggered cravings and daily responses (3 per day). EMA will consist of event-triggered recordings (initiated by participants whenever they use heroin or cocaine, or whenever they feel an urge to do so) and random-signal-triggered recordings (3 per day). During EMA, participants will begin a voucher-based program to encourage abstinence from heroin and cocaine.
  • Participants will also carry global positioning system (GPS) units to record their locations during these 15 weeks, and will complete questionnaires about stress levels at specific intervals during the study.
  • At the end of the study, participants will have the choice of transferring to a community clinic or undergoing an 8-week taper from methadone.

详细描述

Background. We have already completed the original, major arm of this protocol (a natural-history study of craving and lapse). Still open for enrollment is the second minor arm (a within-subject trial of PDA-based treatment-task reminders). In the third arm there will be enhanced assessment of mood, stress, and geographical location to further study craving and lapse. All arms of the study have developed from either or both of two aspects of the original arm: (1) Our growing appreciation of the technical possibilities of electronic data collection in participants daily environments, and (2) our growing interest in having participants provide descriptive data about the day-to-day experience of addiction and recovery.

The major completed arm of the protocol has provided a wealth of descriptive data on drug craving and lapse via Ecological Momentary Assessment (EMA), in which participants carry handheld data-collection devices (electronic diaries, EDs) on which they report, in real time, their activities and moods. Beyond data monitoring, EDs can be used to complement behavioral interventions. The data-collection devices can be additionally programmed to prompt completion of therapist-assigned homework exercises; by extending support outside the therapy session, clinical outcome may be improved. Furthermore, there is an evidenced association between completion of homework exercises and therapeutic outcome. Adapting existing homework assignments to make them more engaging may increase homework completion and, in turn, general compliance with therapy (Arm 2). The rationale for the third arm of the study is to broaden the perspective of the examination of the natural history of drug cravings and lapses by refining our assessments of geographical location and the stressors associated with it. In doing so, we intend to investigate determinants of addiction that are not reducible to individual-level traits but are instead reflective of broader socioeconomic problems manifested in differences among neighborhoods.

Scientific goals. Arm 1) To investigate the relationships between putative triggers and drug craving and lapse; Arm 2) To investigate interactive effects of electronic-diary reminders, and simplified therapy-assigned homework tasks, on homework completion and therapeutic outcome; Arm 3) Using refinements in our assessment methods, to investigate the role of stress associated with geographical location in drug craving and use.

Participant population. Arm 2: 35 cocaine-abusing opioid-dependent outpatients. Arm 3: 50 cocaine-abusing opioid-dependent outpatients (separate from those in Arm 2). Target enrollment for both arms will include 40% women and 60% minorities (mostly African-American).

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研究设计

研究类型
Observational
时间视角
Prospective

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

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

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