Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Dosing antepartum
研究概览
简要总结
This study will assesses the efficacy of buprenorphine/naloxone vs buprenorphine on maternal withdrawal symptoms and drug cravings.
This is a randomized controlled trial to a cohort of pregnant women seeking medication-assisted treatment for opioid use disorders. Half of participants will receive buprenorphine, while the other half of participants receive a combination of buprenorphine/naloxone
详细描述
Buprenorphine and Buprenorphine/naloxone each are used to treat opioid use disorders in pregnancy.
Buprenorphine has many preferential characteristics over methadone including decreased risk of maternal overdose, lower incidence of preterm labor, less frequent clinical visits, shorter duration of neonatal hospital stay and treatment for neonatal abstinence syndrome. Recent studies have found that increasing the dosing frequencies of buprenorphine is more efficacious to prevent maternal withdrawal symptoms, improve compliance, and theoretically produce better pregnancy outcomes.
Buprenorphine/naloxone, a combination opioid of buprenorphine and naloxone, has also been investigated as an alternative to treatment and maintenance for opioid use disorder. The advantage of the combination of buprenorphine with naloxone is that it reduces the potential for abuse. As a partial mu opioid agonist, buprenorphine alone has the capacity to induce typical opioid effects such as euphoria, which are enhanced when the drug is taken intravenously. By combining buprenorphine with naloxone, an opioid antagonist, the capacity for buprenorphine to be abused is reduced.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •With a confirmed viable intrauterine pregnancy
- •Opioid Use Disorder
- •Care in a Stony Brook Medicine OBGYN clinical office sites
- •Medication-assisted treatment through Stony Brook Medicine OBGYN office sites
排除标准
- •Known or suspected allergy to buprenorphine or buprenorphine/naloxone
- •Carrying a fetus with known aneuploidy or anomaly
研究组 & 干预措施
buprenorphine
Buprenorphine 2 mg to 8 mg daily: Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24
Buprenorphine 8 mg to 16 mg daily: Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
干预措施: Buprenorphine (Drug)
buprenorphine/naloxone
Buprenorphine/naloxone 4 mg/1 mg daily once daily or twice daily (BID): Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24
Buprenorphine/naloxone 8 mg/2 mg daily once daily or twice daily (BID): Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
干预措施: Buprenorphine/naloxone (Drug)
结局指标
主要结局
Dosing antepartum
时间窗: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (\>50% increase or decrease) during pregnancy.
Compliance antepartum
时间窗: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in pregnant women. Compliance will include the incidence of urine toxicology testing positive for illicit substances during prenatal care and at the time of admission for delivery.
Compliance postpartum
时间窗: 2 month period postpartum
To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in the postpartum period. Compliance will include the incidence of urine toxicology testing positive for illicit substances from the time of discharge from the hospital following the delivery over a 2 month period postpartum (postpartum period).
Dosing postpartum
时间窗: 2 month period postpartum
Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (\>50% increase or decrease) from the hospital following the delivery over a 2 month period postpartum (postpartum period).
次要结局
- Maternal Outcomes Withdraw Scoring(Duration of pregnancy and 2 months of postpartum period)
- Maternal Outcome Metabolites(At delivery of newborn)
- Placental dysmaturity(At delivery of newborn)
- Neonatal Outcomes(Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life))
- Neonatal stay(Birth to newborn discharge home (from day 0 through 120 days of life))
- Newborn(At birth)
研究者
David Garry DO
Director, Maternal Fetal Medicine
Stony Brook University