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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Republic Vilnius University Hospital
Vilnius, Vilnius County, Lithuania
Cortisol levels
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Time frame: 2 days
Adrenocorticotropic hormone (ACTH) levels
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Time frame: 2 days
Stress response levels according to heart rate
Heart rate measurements were taken 4 times a day
Time frame: 4 days
Stress response levels according to respiratory rate
Respiratory rate measurements were taken 4 times a day
Time frame: 4 days
Stress response levels according to blood pressure
Blood pressure measurements were taken 4 times a day
Time frame: 4 days
Changes of potassium concentration due to stress response
Blood samples were taken 3 times a day
Time frame: 4 days
Changes of sodium concentration due to stress response
Blood samples were taken 3 times a day
Time frame: 4 days
Changes of chloride concentration due to stress response
Blood samples were taken 3 times a day
Time frame: 4 days
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Changes of magnesium concentration due to stress response
Blood samples were taken 3 times a day
Time frame: 4 days
Changes of glucose concentration due to stress response
Blood samples were taken 3 times a day
Time frame: 4 days
Subjective Opiate Withdrawal Scale (SOWS)
Patients were assessed with to SOWS 4 times a day
Time frame: 4 days
Objective Opiate Withdrawal Scale (OOWS)
Patients were assessed with to OOWS 4 times a day
Time frame: 4 days