A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids
概览
- 阶段
- 早期 1 期
- 干预措施
- Buprenorphine Injection
- 疾病 / 适应症
- Opioid Use Disorder
- 发起方
- Rachel R. Luba
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Days Abstinent from Opioids
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are:
Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine?
Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine?
Investigators also seek to understand and explore:
How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes.
How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes.
How factors like craving and opioid withdrawal symptoms influence treatment outcomes.
Participants will:
Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine.
Provide blood and urine samples while on the inpatient unit and at follow up.
Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.
研究者
Rachel R. Luba
Associate Research Scientist
Columbia University
入排标准
入选标准
- •Aged 18 to 65
- •Voluntarily seeking treatment for opioid use disorder (OUD)
- •Consistent use of fentanyl or other high potency synthetic opioids
- •Meets DSM-5 criteria for OUD with at least moderate severity
- •Able to provide written informed consent in English and willing to comply with study procedures
排除标准
- •Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
- •Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)
- •Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
- •Buprenorphine or methadone treatment in the past 30 days
- •Known allergy, hypersensitivity or intolerance to buprenorphine
- •Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
- •Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
- •Liver function tests \> 2x the upper limit of normal
- •Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days
研究组 & 干预措施
Injectable Buprenorphine
Long-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose
干预措施: Buprenorphine Injection
Sublingual Buprenorphine/Naloxone
Titration onto sublingual buprenorphine/naloxone (standard of care)
干预措施: Buprenorphine + naloxone (Suboxone)
结局指标
主要结局
Percentage of Days Abstinent from Opioids
时间窗: 4 week follow up period
Abstinence from Opioids (% days abstinent; continuous; longitudinal) during each week of the 4 week follow up period measured via the timeline follow back.
Sustained Relapse
时间窗: 4 week follow up period
Sustained relapse during the 4 week follow up period (binary), defined as 5 consecutive days of illicit opioid use reported on the timeline follow back at any point during the 4 week follow up period.
次要结局
- Time to Peak Clinical Opiate Withdrawal Scale (COWS) score(During the inpatient induction period (approximately 1 overnight stay))
- Peak Clinical Opiate Withdrawal Scale (COWS) score(During the inpatient induction period (approximately 1 overnight stay))
- Dropout during induction(During the inpatient induction period (approximately 1 overnight stay))