Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 6
- 主要终点
- Number of Participants With Retention in Medication Treatment for OUD
研究概览
简要总结
This study seeks to test a new model of care (ID/LAB) in which opioid use disorder (OUD) is managed by infectious disease (ID) specialists and hospitalists concurrent with management of the OUD-related infections, using long-acting injectable buprenorphine (LAB), followed by referral as soon as possible after hospital discharge to community resources for long term treatment of OUD.
详细描述
There are three specific aims that this study will use to assess a new model of care aimed at treating opioid use disorder (OUD). These aims address whether treatment is maintained by patients, if patients' opioid use outcomes improve and to determine if adherence to treatment for infectious disease results in fewer re-hospitalizations and emergency room visits, as well as improved quality of life.
The specific aims:
Aim1: The primary outcome will be a binary indicator of whether a patient is enrolled in and receiving effective medication treatment for OUD (buprenorphine, methadone, or injection naltrexone) at 12 weeks (3 months) after randomization.
Aim 2: Evidence of improved opioid use outcomes (lower days of using opioids, negative urine opioids).
Aim 3: Have higher rates of completion of the antimicrobial regimen for their infectious disease, decreased re-hospitalizations and emergency room presentations related to either their infectious disease or OUD over the 12-week follow-up period, and improved measures of quality of life.
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
- •Adults able to provide written informed consent in English or Spanish;
- •Current hospitalization with a suspected or known bacterial or viral (HIV/HCV/HBV) infection including but not limited to bacteremia, Candidal fungemia, osteomyelitis, endophthalmitis, septic thrombophlebitis, infected pseudoaneurysm, endocarditis, skin/soft tissue infection (SSTI), or septic arthritis;
- •Current moderate-to-severe OUD (DSM-5);
- •Willing to accept assignment to either ID/LAB or TAU, and to participate in research follow-up visits.
排除标准
- •Severe medical or psychiatric disability making participation unsafe (e.g. imminent suicide risk);
- •Pregnancy, planning conception, or breast-feeding for female participants;
- •Allergy, hypersensitivity or medical contraindication to buprenorphine;
- •Moderate-severe liver impairment in the judgment of the study investigator;
- •Preexisting enrollment on methadone or buprenorphine (SL-B) maintenance AND intending to remain on methadone or buprenorphine maintenance upon discharge (patients already under effective treatment for OUD do not represent the target population of untreated OUD patients entering hospitals, nor would we want to disrupt established effective treatment).
- •Inability or unwillingness of subject to give informed consent.
研究组 & 干预措施
ID/LAB
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
干预措施: ID/LAB (Other)
TAU
Treatment as Usual (TAU).
干预措施: TAU (Other)
结局指标
主要结局
Number of Participants With Retention in Medication Treatment for OUD
时间窗: 12 weeks
Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.
次要结局
- Total Days of Using Opioids(24 weeks)
- Treatment Completion Rate(24 weeks)
- Re-hospitalization/Emergency Room Visits(24 weeks)
- Negative Urine Screens: Opioids(24 weeks)
- Quality of Life Measure of Social and Occupational Functioning(24 weeks)
- Negative Urine Screens: Opioids(4 weeks)
- Negative Urine Screens: Opioids(8 weeks)
- Negative Urine Screens: Opioids(12 weeks)
- Re-hospitalization/Emergency Room Visits(12 weeks)
- Quality of Life Measure of Social and Occupational Functioning(12 weeks)
- Days of Using Opioids(4 weeks)
- Days of Using Opioids(From Week 4 to 8)
- Days of Using Opioids(From Week 8 to 12)
- Days of Using Opioids(24 weeks)
- Negative Urine Screens: Opioids(1 week)
- Treatment Completion(12 weeks)
- Mean Modified PEG Pain Scale Score(4 weeks)
- Mean Modified PEG Pain Scale Score(8 weeks)
- Mean Modified PEG Pain Scale Score(12 weeks)
- Mean Modified PEG Pain Scale Score(24 weeks)
- Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior(4 Weeks)
- Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior(8 Weeks)
- Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior(12 Weeks)
- Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior(24 Weeks)
- Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior(4 Weeks)
- Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior(8 Weeks)
- Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior(12 Weeks)
- Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior(24 Weeks)
- Treatment Satisfaction(12 Weeks)
- Treatment Satisfaction(24 Weeks)
- Unplanned Medical Discharge(baseline)
- Cure of Index Infection(12 Weeks)
- Number of Participants With Hepatitis C (HCV) Detectable Viral Load(12 Weeks)
- Number of Participants With Detectable HIV Viral Load(up to 12 Weeks)
- Mean Days Injecting Drugs(4 weeks)
- Mean Days Injecting Drugs(8 weeks)
- Mean Days Injecting Drugs(12 weeks)
- Mean Days Injecting Drugs(24 weeks)
- Mean Days Other Drug Use(4 weeks)
- Mean Days Other Drug Use(8 weeks)
- Mean Days Other Drug Use(12 weeks)
- Mean Days Other Drug Use(24 weeks)
- Urine Toxicology: Positive Screens(4 weeks)
- Urine Toxicology: Positive Screens(8 weeks)
- Urine Toxicology: Positive Screens(12 weeks)
- Urine Toxicology: Positive Screens(24 weeks)