Treatment-as-Usual (TAU) Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With National Institute on Drug Abuse (NIDA) CTN-0051
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 5
- 主要终点
- Negative UDSs at Week 1
研究概览
简要总结
This is an observational, "ancillary study" intended to describe opioid use among opioid use disorder patients following their discharge into the community from inpatient detoxification and/or short-term residential treatment programs affiliated with parent study CTN-0051, which assessed the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.
详细描述
Participant recruitment will begin after recruitment for CTN-0051 has been completed. Opioid use disorder patients will be recruited prior to leaving detoxification and/or short-term residential programs. Screening and baseline data (focused on demographics, diagnosis and service utilization) will be collected prior to discharge, and follow-up data (focused on opioid use) will be collected at weeks 1, 4 and 8 following discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •18 years or older;
- •Meet DSM-5 criteria for opioid-use disorder (heroin or prescription opioids);
- •Have used opioids other than as specifically prescribed within thirty days prior to consent
- •Seeking treatment for opioid dependence;
- •Able to provide written informed consent;
- •Able to speak English sufficiently to understand the study procedures.
排除标准
- •Serious medical, psychiatric or substance use disorder that, in the opinion of the Site PI, would make participation hazardous to the participant, compromise study findings or prevent the participant from completing the study;
- •Suicidal or homicidal ideation that requires immediate attention;
- •Maintenance on methadone at doses of 30mg or greater at the time of signing consent;
- •Presence of pain of sufficient severity as to require ongoing pain management with opioids;
- •Pending legal action or other reasons that might prevent an individual from completing the study;
- •If female, currently pregnant or breastfeeding or planning on conception;
- •Prior participation in parent trial CTN-0051
结局指标
主要结局
Negative UDSs at Week 1
时间窗: week 1
Number of negative UDSs at Week 1
Negative UDSs at Week 4
时间窗: week 4
Number of negative UDSs at Week 4
Positive UDSs at Week 4
时间窗: week 4
Number of positive UDSs at Week 4
Time to First Use
时间窗: Up to Week 8 Post Discharge
Days to first opioid use from Timeline Followback
Missing UDSs at Week 4
时间窗: week 4
Number of missing UDSs at Week 4
Days of Opioid Use
时间窗: Up to Week 8 Post Discharge
Days of use up 8 weeks post discharge
Negative UDSs at Week 8
时间窗: week 8
Number of negative UDSs at Week 8
Positive Urine Drug Screen (UDS) at Week 1
时间窗: week 1
Number of positive UDSs at Week 1
Missing UDSs at Week 1
时间窗: week 1
Number of missing UDSs at Week 1
Time to Regular Use
时间窗: Up to Week 8 Post Discharge
Days to regular opioid use from Timeline Followback
Missing UDSs at Week 8
时间窗: week 8
Number of missing UDSs at Week 8
Positive UDSs at Week 8
时间窗: week 8
Number of positive UDSs at Week 8
次要结局
未报告次要终点