Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 4
- 主要终点
- OUD treatment entry (number [%] of participants who enter OUD treatment)
研究概览
简要总结
This study will examine the effectiveness of opioid use disorder (OUD) treatment linkage strategies for patients identified at sexual health clinics and through community outreach and referrals. This 3-arm RCT will compare Usual Care vs. Patient Navigation vs. Patient Navigation + Buprenorphine Initiation (UC vs. PN vs. PN+BUP).
详细描述
This study, entitled Opioid Use Disorder Treatment Linkage at Strategic Touchpoints using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people with untreated OUD, recruiting from sexual health clinics and through community outreach and referrals. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with buprenorphine initiation (PN+BUP).
The UC Arm will include standard services at the sexual health clinic / city health department (if applicable), enhanced with brief overdose prevention education (including access to naloxone).
The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment.
The PN+BUP Arm will include all PN Arm services, with the addition of meeting with a study clinician to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community.
Research assessments consisting of a structured interview battery and biomarkers for drug use and sexually transmitted infections will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Age 18 or older
- •Opioid use in the past 30 days
- •DSM-5 diagnostic criteria for OUD with physiological dependence
- •Willing to try buprenorphine treatment.
排除标准
- •current enrollment in OUD treatment with buprenorphine, methadone, or extended-release naltrexone
- •clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists)
- •regular use of illicit long-acting opioid agonists (e.g., methadone; due to potential challenges with dose induction)
- •heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction
- •high dose or intravenous benzodiazepine misuse
- •pregnancy (due to special needs; will be treated outside of the study)
- •unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation)
- •inability to provide informed consent (e.g., failure to pass consent quiz)
研究组 & 干预措施
Patient Navigation + Buprenorphine Initiation (PN+BUP)
The PN+BUP Arm will include all PN Arm services, with the addition of meeting with a study clinician to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. The standard buprenorphine bridge prescription will be for buprenorphine/naloxone film: 8/2mg, up to 16mg per day, 7 day supply.
干预措施: Patient Navigation (Behavioral)
Patient Navigation (PN)
The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment.
干预措施: Patient Navigation (Behavioral)
Patient Navigation + Buprenorphine Initiation (PN+BUP)
The PN+BUP Arm will include all PN Arm services, with the addition of meeting with a study clinician to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. The standard buprenorphine bridge prescription will be for buprenorphine/naloxone film: 8/2mg, up to 16mg per day, 7 day supply.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
OUD treatment entry (number [%] of participants who enter OUD treatment)
时间窗: 1 month
The primary outcome for the trial is OUD treatment entry by 1 month post-enrollment, defined as admission to a buprenorphine provider (either office-based care or a specialty OUD program), or other licensed OUD treatment program (e.g., methadone, medical detox followed by behavioral treatment).
次要结局
- OUD treatment retention(6 months)
- Opioid use (self-report)(6 months)
- Opioid use (urine test)(6 months)
- Cocaine use (self-report)(6 months)
- Cocaine use (urine test)(6 months)
- OUD diagnostic criteria(6 months)
- Opioid overdose(6 months)
- New Diagnoses of HIV/STIs(6 months)
- Adherence to recommended HIV/STI treatment(6 months)
- Sex Risk Behaviors(6 months)
- Drug Risk Behaviors(6 months)