The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
- Conditions
- Opiate Addiction
- Interventions
- Registration Number
- NCT02362256
- Lead Sponsor
- Vilnius University
- Brief Summary
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.
- Detailed Description
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.
Correction of opioid withdrawal symptoms - all of the patients receive medicines for opioid detoxification, infusion therapy in predefined doses.
Antagonist induction - patients receive opioid antagonist (incremental or standard dose). Withdrawal symptoms are assessed and correction with lorazepam is given if needed.
Data collection - data is recorded (demographic, epidemiological, vital signs, opioid withdrawal symptoms, levels of hormones, metabolites, electrolytes).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Naltrexone 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: 1. st hour 50 µg 2. nd hour 50 µg 3. rd hour 100 µg 4. th hour 100 µg 5. th hour 200 µg 6. th hour 400 µg 7. th hour 800 µg 8. th hour 1600 µg 9. th hour 3200 µg 10. 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) Intervention Clonidine 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: 1. st hour 50 µg 2. nd hour 50 µg 3. rd hour 100 µg 4. th hour 100 µg 5. th hour 200 µg 6. th hour 400 µg 7. th hour 800 µg 8. th hour 1600 µg 9. th hour 3200 µg 10. 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) Intervention Lorazepam 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: 1. st hour 50 µg 2. nd hour 50 µg 3. rd hour 100 µg 4. th hour 100 µg 5. th hour 200 µg 6. th hour 400 µg 7. th hour 800 µg 8. th hour 1600 µg 9. th hour 3200 µg 10. 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) Control Clonidine 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) Control Naltrexone 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) Control Lorazepam 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)
- Primary Outcome Measures
Name Time Method Cortisol levels 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 2 days Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
- Secondary Outcome Measures
Name Time Method Stress response levels according to heart rate 4 days Heart rate measurements were taken 4 times a day
Stress response levels according to respiratory rate 4 days Respiratory rate measurements were taken 4 times a day
Stress response levels according to blood pressure 4 days Blood pressure measurements were taken 4 times a day
Changes of potassium concentration due to stress response 4 days Blood samples were taken 3 times a day
Changes of sodium concentration due to stress response 4 days Blood samples were taken 3 times a day
Changes of chloride concentration due to stress response 4 days Blood samples were taken 3 times a day
Changes of magnesium concentration due to stress response 4 days Blood samples were taken 3 times a day
Changes of glucose concentration due to stress response 4 days Blood samples were taken 3 times a day
Subjective Opiate Withdrawal Scale (SOWS) 4 days Patients were assessed with to SOWS 4 times a day
Objective Opiate Withdrawal Scale (OOWS) 4 days Patients were assessed with to OOWS 4 times a day
Trial Locations
- Locations (1)
Republic Vilnius University Hospital
🇱🇹Vilnius, Lithuania