The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cortisol levels
研究概览
简要总结
The aim of this study is to investigate which method of naltrexone induction during rapid opioid detoxification causes stronger stress response and has a higher influence on opioid abstinence caused by opioid induction.
详细描述
Study enrolls opiate addicted patients who are motivated for a long term treatment and full opiate abstinence. Patient is offered to take part in a study. Information is provided regarding protocol, aim and course of study. Patients who are eligible and consent for study commit to follow the pre-study recommendations.
Study consists of:
Primary assessment - information about study. Assessment of patient according to predefined criteria. Consent form. Allocation of the treatment date.
Stabilization - Buprenorphine. Assessment according to SOWS and OWS. Total amount of buprenorphine is recorded.
Repeated evaluation - patient after successful stabilization course undergoes urine test for psychotropic substances, blood alcohol level is recorded. If any test is positive patient is not enrolled to study.
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)
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
- •Opiate addiction
- •Use of short-acting opiate (morphine or heroine)
- •Age > 18 years
- •Length of opiate addiction > 1 year
- •Patient can make a decision for detoxification and has a capacity to consent for procedure
- •Written consent for procedure
排除标准
- •Polyvalent addiction
- •Pregnancy or breast feeding
- •Cardiovascular pathology
- •Acute or chronic kidney disease
- •Decompensated liver pathology (jaundice, ascites, hepatic encephalopathy)
- •Infective complications of opiate addiction (pneumonia, phlegmon, abscess, thombophlebitis, sepsis)
- •Malnutrition (Nutritional risk screening 2002 score ≥3)
- •Diabetes mellitus
- •Previous history of psychosis
- •Glasgow coma scale < 15
- •Abdominal surgical intervention during last 30 days
- •Cumulative buprenorphine dose for stabilization < 8 mg
- •Positive test for psychoactive substances during treatment
- •Refusal to participate in study at any point of it
研究组 & 干预措施
Intervention
Opioid antagonist induction. Day 4. Duration 12-16 hours.
Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol:
- st hour 50 µg
- nd hour 50 µg
- rd hour 100 µg
- th hour 100 µg
- th hour 200 µg
- th hour 400 µg
- th hour 800 µg
- th hour 1600 µg
- th hour 3200 µg
- th hour 6000 µg
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
干预措施: Naltrexone (Drug)
Intervention
Opioid antagonist induction. Day 4. Duration 12-16 hours.
Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol:
- st hour 50 µg
- nd hour 50 µg
- rd hour 100 µg
- th hour 100 µg
- th hour 200 µg
- th hour 400 µg
- th hour 800 µg
- th hour 1600 µg
- th hour 3200 µg
- th hour 6000 µg
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
干预措施: Clonidine (Drug)
Intervention
Opioid antagonist induction. Day 4. Duration 12-16 hours.
Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol:
- st hour 50 µg
- nd hour 50 µg
- rd hour 100 µg
- th hour 100 µg
- th hour 200 µg
- th hour 400 µg
- th hour 800 µg
- th hour 1600 µg
- th hour 3200 µg
- th hour 6000 µg
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
干预措施: Lorazepam (Drug)
Control
Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
干预措施: Naltrexone (Drug)
Control
Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
干预措施: Clonidine (Drug)
Control
Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
干预措施: Lorazepam (Drug)
结局指标
主要结局
Cortisol levels
时间窗: 2 days
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Adrenocorticotropic hormone (ACTH) levels
时间窗: 2 days
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
次要结局
- Stress response levels according to heart rate(4 days)
- Stress response levels according to respiratory rate(4 days)
- Stress response levels according to blood pressure(4 days)
- Changes of potassium concentration due to stress response(4 days)
- Changes of sodium concentration due to stress response(4 days)
- Changes of chloride concentration due to stress response(4 days)
- Changes of magnesium concentration due to stress response(4 days)
- Changes of glucose concentration due to stress response(4 days)
- Subjective Opiate Withdrawal Scale (SOWS)(4 days)
- Objective Opiate Withdrawal Scale (OOWS)(4 days)
研究者
Robertas Badaras
MD Robertas Badaras
Vilnius University