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临床试验/NCT00249496
NCT00249496已完成不适用

Therapeutic Workplace Maintenance Study

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Percentage of Monthly Urine Samples That Are Negative for Cocaine

研究概览

简要总结

This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence & Employment, or an Employment Only group. Participants in the Abstinence & Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.

详细描述

STUDY PARTICIPANTS This study was approved by the Western Institutional Review Board. Participants were recruited in methadone clinics throughout Baltimore. Recruitment began in October 2003, and the study was completed in August 2007. Of the 251 individuals assessed for eligibility, 128 met these criteria and were invited to participate in the study.

SETTING The study was conducted at the Center for Learning and Health, Johns Hopkins School of Medicine, Baltimore, MD. The workplace included a sign-in station, a urinalysis laboratory, and three workrooms. The workrooms contained 47 computer workstations.

PRE-RANDOMIZATION PROCEDURES Intake Assessment At intake, participants signed informed consent and completed an interview. Urine samples were collected and tested for cocaine, opiates, benzodiazepines, methadone, and amphetamines. A questionnaire was administered to assess participants' capacity to operate a keyboard. The Composite International Diagnostic Interview (CIDI), 2nd ed. was administered to assess drug dependence. Other assessment tools included the Addiction Severity Index - Lite (ASI-Lite), the Risk Assessment Battery (RAB), the Wide Range Achievement Test (WRAT-3), and a reading assessment. Participants were paid $30 in vouchers for completing the interview.

Workroom and Urinalysis Procedures Eligible participants were enrolled in phase 1 and could work in the workplace from 10 AM-12 PM and 1 PM-3 PM every weekday for 6 months. During this phase, participants worked on computerized training programs designed to teach them to become data entry operators. On Monday, Wednesday and Friday, participants provided a urine sample under observation. Breath samples were tested for alcohol. Urine samples were tested for opiates and cocaine and participants received graphs showing current and prior drug test results. Participants earned a base pay of $8.00 per hour in vouchers. Additionally, participants could earn approximately $2.00 per hour in vouchers in productivity pay for working on training programs. Earnings accumulated in the participant's account until exchanged for a gift card or other approved goods and services.

Initially, participants could attend the workplace independent of their urinalysis results. This "workplace induction" continued for at least 4 weeks and until the participant worked for at least 5 min on 15 workdays. After workplace induction, participants were required to provide evidence of cocaine abstinence to work and to maintain maximum pay. Specifically, participants gained access to their workrooms if urinary benzoylecgonine concentration was <300 ng/mL or at least 20% lower per day since the last sample submitted. Participants who provided a cocaine-positive urine sample could not work until they provided a new sample that met the criteria. Upon return to work, the rate of base pay was reduced to $1.00 per hour. Base pay was then increased by $1.00 per hour every day that a participant provided a sample that met the criteria and worked at least 5 minutes until reaching $8.00 per hour. Missing samples were treated as positive. After a participant provided cocaine-negative samples for three consecutive weeks, the abstinence contingency was extended to opiates (ie, urinary benzoylecgonine and morphine concentrations of <300 ng/mL, or decreases in benzoylecgonine and morphine concentrations by at least 20% per day since the last sample submitted). After providing cocaine- and opiate-negative samples for three consecutive weeks the contingency was expanded to include alcohol if the participant had provided alcohol positive (≥0.003 ng/L) samples during the opiate and cocaine contingency period. This stepped contingency program is described in detail elsewhere.

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

  • Applicants in methadone treatment may be eligible to participate in Phase 1 of the study.
  • Applicants will be blind to the full details of the eligibility criteria.
  • Unemployed
  • Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program
  • Met DSM-IV criteria for cocaine dependence
  • Were receiving welfare benefits in Baltimore, MD
  • Received a score of less than or equal to 80% correct on a reading assessment
  • Exclusion Criteria
  • Being at imminent risk for suicide
  • Reported hallucinations
  • Being incarcerated or otherwise under constant monitoring
  • Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month
  • Having physical limitations that prevented typing

排除标准

  • 未提供

结局指标

主要结局

Percentage of Monthly Urine Samples That Are Negative for Cocaine

时间窗: 1 year

The percentage of urine samples collected at monthly assessments that are negative for cocaine.

次要结局

  • HIV Risk Behaviors(1 year)
  • Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine(1 year)
  • Percentage of 30-day Assessment Urine Samples Negative for Opiates(1 year)
  • Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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