Drug Treatment for Transplant Candidates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Abstinence
研究概览
简要总结
The purpose of this study is to test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.
详细描述
Participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at St. Luke's-Roosevelt Hospital Center (renal), Columbia Presbyterian Hospital (renal/liver) and Virginia Commonwealth University Medical Center (liver). Baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at St. Luke's. Participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. The telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.
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
- 否
入选标准
- •End stage liver or renal disease
- •Having used drugs or alcohol during the past 6 months
- •Turned down for transplant due to current or recent substance use
- •Access to telephone
排除标准
- •Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
- •Moderate to severe hepatic encephalopathy
- •Non-English speaking
研究组 & 干预措施
TAU
Treatment As Usual
干预措施: TAU (Other)
结局指标
主要结局
Abstinence
时间窗: 3 month time frame
次要结局
- Stage of Change, illness response, psychological stress(3 month time frame)