Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Urinalysis-confirmed abstinence from opioids at 3 month follow up
研究概览
简要总结
The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.
详细描述
This study will help to inform best practices for providing psychosocial treatment within the context of office-based opioid treatment (OBOT) with buprenorphine. We will use a staged approach to develop and evaluate an adaptive approach to the provision of adjunctive psychosocial treatment that includes medication management by a buprenorphine provider and linkage to CRSs and CBT depending on the needs of the patient. The specific aims of the proposal are listed below.
Aim 1: Work collaboratively with our multidisciplinary team to develop specific protocols for the CRS and CBT interventions and establish algorithms based on behavioral criteria to determine when each intervention should be implemented. As a part of this aim, we will also develop standard procedures for delivering each intervention and train interventionists [i.e., CRSs and Licensed Professional Counselors (LPCs)] to deliver them with fidelity.
Aim 2: Conduct a two-group randomized study to evaluate the efficacy of the adaptive intervention relative to TAU. Outcomes to be examined will include urinalysis-confirmed opioid use, retention in buprenorphine- based OBOT, quality of life, and psychosocial functioning through one year post-study entry.
Aim 3: Conduct a qualitative evaluation of the intervention and develop a strategic plan for its dissemination. We will conduct focus groups with clinic staff and relevant stakeholders to determine the utility and acceptability of the adaptive intervention. In addition, we will hold an expert roundtable to identify mechanisms for increasing sustainability and enhancing adoption by other office-based buprenorphine programs to inform the development of the strategic plan.
Aim 4: Establish a training program in clinical research for minority students. Eight undergraduate students from a historically minority higher education institution will be selected to participate in 9-month internships during which they will receive comprehensive and pragmatic training in the full range of clinical research from study design to dissemination.
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
- •Have initiated office-based buprenorphine treatment for OUD at the FQHC within the last 4 weeks;
- •Not require an inpatient level of care as determined by the healthcare provider; and
- •Be capable of providing valid contact information and informed consent.
排除标准
- •Patient is under the age of 18;
- •Co-morbid psychiatric disorder indicating the need for more intensive residential treatment
- •Patient is unable to provide informed consent.
- •Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.
结局指标
主要结局
Urinalysis-confirmed abstinence from opioids at 3 month follow up
时间窗: 3 months post study entry
Participants will provide a urine specimen at the 3 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Urinalysis-confirmed abstinence from opioids at 6 month follow up
时间窗: 6 months post study entry
Participants will provide a urine specimen at the 6 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Urinalysis-confirmed abstinence from opioids at 12 month follow up
时间窗: 12 months post study entry
Participants will provide a urine specimen at the 12 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Urinalysis-confirmed abstinence from opioids at 9 month follow up
时间窗: 9 months post study entry
Participants will provide a urine specimen at the 9 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
次要结局
- Retention in buprenorphine-based OBOT(Through 12 months post-study entry)
- Quality of life assessment(Through 12 months post-study entry)
- Psychosocial functioning/Multidimensional problem severity(Through 12 months post-study entry)
- Abstinence from or reductions in use of other (non-opioid) psychoactive substances(Through 12 months post-study entry)
- Treatment satisfaction(Through 12 months post-study entry)