Opiate Addiction Clinical Trial
Official title:
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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