A Pilot Study Comparing a Low-dose Versus a High-dose Sublingual Buprenorphine Induction Dosing Scheme in Fentanyl Using Patients With Opioid Use Disorder (OUD)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- pharmacotherapy adherence
研究概览
简要总结
This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week.
详细描述
This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week. Thereafter, they will be treated according to the MATClinics usual schedule of clinic visits. The number and timing of visits may vary according to whether the participant is still using illicit opioids. Follow-up visits for the study will be at one and three months.The primary objective is to determine whether patients randomly assigned to low versus high dose induction regimens are more likely to complete the 7-day induction period. Secondary outcomes are the number of patients who develop precipitated withdrawal or other adverse events, experience subjective opioid withdrawal symptoms, use adjunctive medications (hydroxyzine, loperamide, dicyclomine, clonidine, ibuprofen, methocarbamol, trazodone, ondansetron) provided by the clinic, recommendation of the medication induction scheme to other patients, and treatment retention at 1- and 3- months post induction.
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
- 是
入选标准
- •Adult male or female (≥ 18 years of age) persons with a DSM-5 diagnosis of OUD;
- •Must have a fentanyl positive urine test;
- •Able to come to the clinic every day for the first week of treatment.
排除标准
- •No exclusionary medical history or mental health issues as determined by the admitting provider; e.g., patients with untreated or unstable serious mental illness, including psychotic disorders;
- •Alcohol withdrawal requiring pharmacological management;
- •Urine positive for buprenorphine, benzodiazepines, or methadone;
- •Enrolled in a methadone treatment program in the past 14 days;
- •Inability to pass a study enrollment quiz.
研究组 & 干预措施
high dose
High dose: Participants randomized to the high dose group will receive on day 1 in the clinic an initial dose of 2 mg of buprenorphine/naloxone, followed by a 6 mg dose an hour later, followed by an 8 mg dose an hour later, followed by an 8 mg dose an hour later. On day 2 they will receive a 12 mg dose in the clinic and a 12 mg dose as take-home medication. On days 3 through 7 they will report to the clinic and receive their 12 mg morning dose and a 12 mg dose as a take-home for evening dosing. Thereafter, dosing adjustments can be made in the first three months of the trial.
干预措施: buprenorphine/naloxone (Drug)
low dose
Low dose: Participants randomized to the low dose group will receive 0.5 mg of buprenorphine/naloxone on day 1, 0.5 mg bid on day 2, 1.0 mg bid on day 3, 2.0 mg bid on day 4, 4.0 mg bid on day 5, 4.0 mg tid on day 6, and 8 mg bid on day 7. Thereafter, dosing adjustments can be made in the first three months of the trial.
干预措施: buprenorphine/naloxone (Drug)
结局指标
主要结局
pharmacotherapy adherence
时间窗: out of 7 days
number of days adherent to dose induction regiment
次要结局
- Subjective Opiate Withdrawal Scale (SOWS)(1-7 days)
- Clinical Opiate Withdrawl Scale (COWS)(1-7 days)
- Time Line Follow-Back (TLFB) Self-reported illicit opioid use(baseline, 1-7 days, 1 month, 3 month)
- Adjunctive medications(1-7 days)
- Concomitant medications checklist(1-7 days, 1 month, 3 month)
- Adverse events (AEs) reporting form(baseline, 1-7 days, 1 month, 3 month)
- Illicit opioid urine test results(baseline, 1-7 days, 1 month, 3month)