NCT01153477已完成2 期
Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Time Line Follow Back
研究概览
简要总结
The purpose of this challenge grant is to conduct an initial test of a new, enhanced version of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been modified to include the elements of our existing continuing care intervention plus patient-centered changes to boost patient involvement and community linkages. The investigators will recruit 150 cocaine dependent patients in publicly funded, community-based programs and randomize them to treatment as usual or the TMAC-E and follow them for 12 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) qualify for a DSM-IV diagnosis of cocaine dependence, with some cocaine use in the prior 6 months;
- •(2) be 18 to 75 years of age;
- •(3) have no current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
- •(4) have no acute medical problem requiring immediate inpatient treatment;
- •(5) not be in methadone or other modes of Drug and Alcohol treatment, other than Intensive Outpatient Program;
- •(6) be willing to be randomized and participate in research;
- •(7) because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.
排除标准
- •have a current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
- •have acute medical problem requiring immediate inpatient treatment;
- •are in methadone or other modes of DA treatment, other than IOP;
- •or cannot provide names of people who can get messages to them for follow up, in the event we cannot locate the participant at their original address and number. Also, if they are court mandated to treatment or otherwise considered a prisoner, they will be ineligible for the study as we have not applied for Subpart C approval.
结局指标
主要结局
Time Line Follow Back
时间窗: 12 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
次要结局
未报告次要终点
研究者
研究点 (2)
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