Starting Treatment With Agonist Replacement Therapies Follow-up Study
START Follow-up Study (NIDA CTN Protocol 0050)
The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269) about 2 to 5 years since they were originally recruited from 8 substance abuse treatment clinics (located in 5 states) to participate in a prior clinical trial study called "START" (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be conducted over 5 years and will involve three follow-up interviews with START participants.
The specific aims of the START Follow-up Study are as follows.
- To determine longer-term outcomes of Suboxone versus methadone treatment received in the START
- To investigate patient and treatment factors associated with post-START treatment access, utilization, and outcomes among Suboxone and methadone patients
- To explore other correlates of the long-term outcomes among START patients.
研究概览
地位
条件
详细说明
The primary outcome is the trajectory of opioid use since START entry, operationalized as number of days using opioids per month over the follow-up period since START enrollment. Other long-term outcomes of interest will include alcohol and other drug use, mental and physical health, quality of life, criminal justice status, HIV/HCV risk behaviors, and mortality. Treatment access and utilization factors of interest will include: predisposing personal factors, treatment experiences, and perceptions and attitudes toward treatment. Other correlates of interest will include cognitive functioning, mental health functioning, and social support.
2.2 Hypotheses There will be no differences in long-term outcomes of participants randomized to Suboxone treatment versus methadone treatment. To assess this outcome, trajectories of opioid use (operationalized as number of days using opioids per month over the follow-up period since START enrollment) will be analyzed. Other secondary long-term outcomes of interest will also be analyzed and will include alcohol and other drug use, mental and physical health, quality of life, criminal justice status, HIV/HCV risk behaviors, and mortality. Participants with greater access and utilization of treatment, fewer predisposing personal factors, greater social support, and more positive perceptions and attitudes toward treatment, will be more likely to be a member of the low or decreasing drug use trajectories.
2.3 Study Design This longitudinal, observational study will involve contacting the study participants from the original START study for future assessments. The study is expected to be completed in five years.
The follow-up study will consist of three interviews of the START study participants, beginning approximately 2 to 5 years after initial enrollment in the START study and will assess these participants over a 5-year period to provide long-term outcome data 7 to 10 years after START enrollment. This study information will be supplemented by (electronic) medical and other administrative records, as available. An intent-to-treat design will be adopted to include all 1,269 study participants enrolled in START.
Figure 1 presents a summary of the timeline for the conduct of project activities. There will be three participant interviews over the five years of the project. After receiving IRB approval for the conduct of the study, the START community treatment provider (CTP) or Node staff will contact their START participants, obtain participant consent to take part in the follow-up study, and conduct the initial assessment. This assessment will take place in the clinic if possible and by phone if the participant is not able to come in person.
By agreeing to take part in this study the participant will agree to:
- Updating their locator information initially and throughout the duration of the study;
- Sharing of clinic and survey data with the lead research team (UCLA);
- Completing various assessments and providing urine and oral fluid/blood specimens for lab assessments;
- Providing access to administrative records (e.g., medical records, criminal justice records);
- Being contacted by the study staff for 2 more interviews in person or by phone (consented prior to each interview).
Local CTP or Node staff will conduct the Visit 1 interview in Years 1-2 of the START follow-up study. Enrollment for the Visit 1 interview will remain open for the life of the study to allow sites that are able to continue to seek participants for Visit 1 beyond Year 2 of the study to do so. The Lead Node staff will conduct the Visit 2 interview by telephone approximately 12 months after the completion of Visit 1. The Lead Node and/or CTP staff will conduct another participant interview approximately 12-18 months after Visit 2 is completed. If a study participant is found late in the study progress for Visit 1, the following visits, 2 and 3 will occur sooner than originally planned, but as far apart as possible. All assessments are completed by the end of Year 5 of the START follow-up study.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
California
-
Los Angeles、California、美国、90016
- Matrix Institute on Addictions
-
Sacramento、California、美国、95838
- Bi-Valley Medical Clinic, Inc.
-
San Francisco、California、美国、94102
- BAART Programs
-
-
Connecticut
-
Hartford、Connecticut、美国、06120
- Hartford Dispensary
-
New Haven、Connecticut、美国、06510
- Yale University School of Medicine
-
-
Oregon
-
Portland、Oregon、美国、97214
- CODA, Inc.
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19137
- NET Steps
-
-
Washington
-
Seattle、Washington、美国、98134
- Evergreen Treatment Services
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- To be eligible to participate in the study, individuals must have participated in CTN-0027 START.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Opioid use as determined by the Timeline Follow Back measure
大体时间:from 2006-2009 to 2011-2016
|
Opiate use over approximately ten years time period
|
from 2006-2009 to 2011-2016
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
mortality
大体时间:from 2006-2009 to 2011-2016
|
Rate of mortality over approximately ten years time period
|
from 2006-2009 to 2011-2016
|
合作者和调查者
调查人员
- 首席研究员:Yih-Ing Hser, Ph.D.、University of California, Los Angeles
出版物和有用的链接
一般刊物
- Hser YI, Zhu Y, Fei Z, Mooney LJ, Evans EA, Kelleghan A, Matthews A, Yoo C, Saxon AJ. Long-term follow-up assessment of opioid use outcomes among individuals with comorbid mental disorders and opioid use disorder treated with buprenorphine or methadone in a randomized clinical trial. Addiction. 2022 Jan;117(1):151-161. doi: 10.1111/add.15594. Epub 2021 Jun 22.
- Evans EA, Yoo C, Huang D, Saxon AJ, Hser YI. Effects of access barriers and medication acceptability on buprenorphine-naloxone treatment utilization over 2 years: Results from a multisite randomized trial of adults with opioid use disorder. J Subst Abuse Treat. 2019 Nov;106:19-28. doi: 10.1016/j.jsat.2019.08.002. Epub 2019 Aug 7.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.