跳至主要内容
临床试验/NCT02143063
NCT02143063已完成不适用

Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

UConn Health8 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
274
试验地点
8
主要终点
Longest Duration of Abstinence From Cocaine

研究概览

简要总结

Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care, standard care plus traditional twice weekly reinforcement, or standard care plus adaptive variable interval reinforcement.

详细描述

Reinforcement interventions have pronounced effects on reducing cocaine use. We developed and evaluated a low-cost reinforcement intervention, systematically moving it through the Stages of development to dissemination and broad clinical implementation. In an ongoing project, reinforcement interventions are yielding benefits when reinforcers are provided at treatment initiation and for longer durations. However, less than half of patients remain engaged for 12 weeks with traditional reinforcement interventions, which require frequent attendance for monitoring and reinforcing abstinence. Interventions that extend into aftercare and that are acceptable to and efficacious in preventing long-term relapse are critically needed.

Reinforcement interventions are efficacious during periods they are in effect, and pilot data show that variable interval (VI) reinforcement schedules, once behavior change occurs, hold potential for maintaining gains when administered infrequently. Assessing methods to extend benefits of these interventions is of paramount scientific and clinical concern. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. In this intervention, reinforcement will be available for 24 weeks, on a progressive VI schedule, that adapts according to patient status. Patients who maintain abstinence earn maximum reinforcers as infrequently as every three weeks on average, while frequency of monitoring and reinforcing abstinence will increase in those who relapse until abstinence is re-instated.

To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care (SC), SC+traditional twice weekly reinforcement, or SC+adaptive VI reinforcement. Evaluations will be completed at baseline and throughout 18 months to assess objective and self-reported indices of drug use, psychosocial problems, and HIV risk behaviors. Primary hypotheses are (1) the adaptive VI reinforcement intervention will improve outcomes relative to standard care during the treatment period and throughout follow-up, and (2) the adaptive VI reinforcement intervention will improve outcomes relative to the traditional reinforcement system. This study will also evaluate the roles of cognitive control and treatment outcome. Patients with better cognitive control are expected to maintain longer durations of abstinence across conditions. If these measures differentially relate to outcomes across treatments, such results suggest the potential of pairing reinforcement interventions to individuals most likely to benefit from them; they may also indicate possible markers of response in a treatment-specific manner. If cognitive indices mediate treatment response, future studies can refine interventions to improve cognitive processes and long-term outcomes.

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

  • be age 18 years or older
  • have a cocaine use disorder diagnosis
  • be willing to sign informed consent and able to pass an informed consent quiz

排除标准

  • serious, uncontrolled psychiatric illness
  • in recovery from pathological gambling
  • do not speak English

结局指标

主要结局

Longest Duration of Abstinence From Cocaine

时间窗: baseline through 6 months

Longest duration of consecutive cocaine-negative urine toxicology tests

次要结局

  • Longest Duration of Abstinence From All Substances Tested(baseline through 6 months)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Alessi

Associate Professor

UConn Health

研究点 (8)

Loading locations...

相似试验

Extending Long-term Outcomes Through an Adaptive... | 临床试验