Genetic polymorphism and treatment outcomes in opioid use disorder patients: A study of OPRD1 and OPRM1 variants in Buprenorphine and Naloxone pharmacotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Treatment retention- time in weeks until buprenorphine/naloxone treatment discontinuation
研究概览
简要总结
Aim:
To assess pharmacogenetic factors related to buprenorphine/naloxone treatment response in opioid use disorder patients.
Primary objective:
To compare treatment retention between OPRD1 and OPRM1 variants.
Secondary objectives:
Compare the proportion of negative urine drug screens
Compare the mean daily dose requirements
Analyse adverse effects of buprenorphine/naloxone
Methodology:
Sample size: 420 participants meeting inclusion and exclusion criteria.
Study site: Conducted at PGIMER, Chandigarh, India, in collaboration with the Pharmacology and Psychiatry departments.
Design: Prospective observational study.
Plan:
Select participants and obtain consent.
Screen and exclude if needed.
Genotype blood samples.
Weekly adherence follow-up.
Urine screening for non-buprenorphine opioids during treatment.
Monitor adverse effects.
Sampling: Draw 5 mL venous blood via IV catheters. Collect monthly urine samples in sterile containers.
Outcomes:
Primary outcome: Treatment retention
Secondary outcomes: Proportion of negative urine drug screens for relapse, mean daily buprenorphine dose, percentage of buprenorphine-associated adverse effects.
Statistical Evaluation: Conduct appropriate statistical analysis to identify significant associations between pharmacogenomic variants and treatment outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-65 years, Either gender, Diagnosis of moderate or severe OUD as per DSM-V criteria or opioid dependence as per ICD-11, Providing written informed consent, Participants within a week of initiating buprenorphine naloxone (BNX) treatment.
排除标准
- •Presence of cardiomyopathy, Patients with liver disease.
结局指标
主要结局
Treatment retention- time in weeks until buprenorphine/naloxone treatment discontinuation
时间窗: assessed every week
次要结局
- Proportion of negative urine screen for opioids other than buprenorphine, Mean daily dose of buprenorphine(buprenorphine and naloxone), Adverse effects associated with buprenorphine
研究者
Bikash Medhi
Post graduate institute of medical education and research, Chandigarh