Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Successful induction of bup/nx with low levels of withdrawal
研究概览
简要总结
The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.
详细描述
This is a randomized, controlled, open-label superiority trial involving 50 individuals with OUD. Participants will be randomized into two arms: rapid micro-induction and standard induction (based on the American Society of Addiction Medicine Practice Guidelines and product monograph) of bup/nx.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria;
- •Individuals seeking Opioid Agonist Treatment (OAT);
- •Be 19 years of age or older;
- •Be willing and able to adhere to the study protocol and follow-up schedule;
- •Be able to provide written informed consent to participate in the clinical trial.
- •If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study.
排除标准
- •Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment;
- •Anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone;
- •Positive pregnancy test for women of childbearing potential;
- •Methadone use in the past 5 days;
- •Buprenorphine use in the past 5 days;
- •Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;
- •Anticipation that the patient may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion;
- •Unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study.
研究组 & 干预措施
Rapid Micro-Induction
On Day 1, participants will receive 0.5mg bup/nx sublingually (SL) every 3 hours (Q3H) - total daily dose of 4mg. On Day 2, they will receive 1mg bup/nx SL Q3H - total daily dose of 8mg. On Day 3, they will receive 8mg bup/nx SL once and 1-4mg bup/nx SL Q3H as needed (PRN) for withdrawal symptoms and/or craving and/or pain - maximum daily dose of 32mg. Afterwards, their day 3 total dose will be consolidated to once daily dosing - maximum daily dose of 32mg. On Days 1 and 2, participants will concurrently receive 1-48mg hydromorphone orally, intravenously, subcutaneously, or intramuscularly (PO/IV/SC/IM) Q1 to 3H PRN for withdrawal symptoms and/or craving and/or pain, titrated to effect (start at lower end of dosing range). Hydromorphone will be discontinued on Days 3 onwards.
干预措施: Buprenorphine/naloxone (Drug)
Rapid Micro-Induction
On Day 1, participants will receive 0.5mg bup/nx sublingually (SL) every 3 hours (Q3H) - total daily dose of 4mg. On Day 2, they will receive 1mg bup/nx SL Q3H - total daily dose of 8mg. On Day 3, they will receive 8mg bup/nx SL once and 1-4mg bup/nx SL Q3H as needed (PRN) for withdrawal symptoms and/or craving and/or pain - maximum daily dose of 32mg. Afterwards, their day 3 total dose will be consolidated to once daily dosing - maximum daily dose of 32mg. On Days 1 and 2, participants will concurrently receive 1-48mg hydromorphone orally, intravenously, subcutaneously, or intramuscularly (PO/IV/SC/IM) Q1 to 3H PRN for withdrawal symptoms and/or craving and/or pain, titrated to effect (start at lower end of dosing range). Hydromorphone will be discontinued on Days 3 onwards.
干预措施: Hydromorphone (Drug)
Standard Induction
Day 1 is initiated when participants score 11 or above on the Clinical Opiate Withdrawal Scale (COWS), and when they have been abstinent from short-acting opioids for at least 6-12 hours or from long-acting opioids for 24-72 hours. On Day 1, participants will start with 2 or 4mg bup/nx SL. If their COWS score increases, bup/nx will be held. If their COWS score remains the same or decreases, additional dosing can be done in increments of 2mg bup/nx SL every 2 hours (Q2H) as needed (PRN). On Day 2, dosing will be consolidated to once daily dosing. The maximum total daily dose for Day 1 and 2 is 32mg.
干预措施: Buprenorphine/naloxone (Drug)
结局指标
主要结局
Successful induction of bup/nx with low levels of withdrawal
时间窗: Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
This is defined as the following: participants who remain in treatment until they have received a total daily dose of ≥ 8mg of bup/nx (successful induction), and score ≤ 12 on the COWS (low levels of withdrawal) from baseline to when they reach that dose.
次要结局
- Client satisfaction(Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm))
- Physical health(Baseline (both arms))
- Treatment retention(Day 7)
- Appearance of adverse events(Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm))
- Illicit drug use(Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm))
- Drug use behaviour(Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm))
- Craving(Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm))
- Pain(Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm))
研究者
Nickie Mathew
Clinical Associate Professor
University of British Columbia