Buspirone as an Adjunctive Medication for Opioid Tapering
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Taper Completion
研究概览
简要总结
This is a pilot study to collect preliminary data to support a grant application. The goal of the study is to evaluate whether the Food and Drug Administration (FDA)-approved and generically-available medication buspirone reduces symptoms of opioid withdrawal among patients undergoing a clinically-indicated and supervised taper from their opioid pain medications. This is premised on strong preclinical scientific support but has not yet be well-examined in humans.
详细描述
Buspirone (Buspar) has shown initial efficacy in reducing symptoms of opioid withdrawal in animal studies and in human patients undergoing a methadone taper. Buspirone may have pharmacologic activity in specific neurotransmitter systems that preclinical evidence suggests may be implicated in the manifestation of opioid withdrawal symptoms. Administration of buspirone during an opioid taper may improve outcomes relative to placebo. The goal of this study is to collect preliminary feasibility and efficacy data from a sample of patients undergoing clinically-indicated opioid tapering. Participant enrollment will occur at the beginning of their residential stay on the Pain Treatment Unit at Johns Hopkins Hospital. Participants will be randomly assigned to receive buspirone (15 milligrams, three times daily, for daily dose of 45 milligrams) or placebo. Daily assessments for withdrawal and requests for additional symptomatic medications will be evaluated as evidence of initial efficacy. Feasibility measures include willingness to participate and study retention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind placebo controlled study. Patients are randomized to receive either active buspirone or placebo, each of which is over-encapsulated to support blinding.
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
- •Be at least 18 years old
- •Be undergoing taper of prescribed opioid pain medications at the study site
排除标准
- •Being pregnant or breastfeeding
- •Past 7-day use of grapefruit juice or other strong Cytochrome (CYP) P450 inhibitors or inducers
- •Have medical or psychiatric condition that is contraindicated with buspirone administration
- •Current suicidality as assessed by clinic staff or the Columbia Suicide Severity Rating Scale
研究组 & 干预措施
Buspirone oral capsule
Buspirone (15 milligrams) administered orally three times per day
干预措施: Buspirone oral capsule (Drug)
Placebo oral capsule
Placebo administered orally three times per day
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Taper Completion
时间窗: 28 days
Final day on which participant is enrolled in the clinic
Opioid Withdrawal Symptom Severity
时间窗: 28 days
Daily ratings of the Subjective Opiate Withdrawal Scale (SOWS)Total Score. The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.
次要结局
未报告次要终点