Republic Vilnius University Hospital
Vilnius, Vilnius County, LT-04130, Lithuania
NCT Number: NCT02362256
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Vilnius, Vilnius County, LT-04130, Lithuania
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Vivitrol, Revia
Other names: Catapres, Kapvay
Other names: Ativan
Time frame: 2 days
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
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Time frame: 4 days
Heart rate measurements were taken 4 times a day
Time frame: 4 days
Respiratory rate measurements were taken 4 times a day
Time frame: 4 days
Blood pressure measurements were taken 4 times a day
Time frame: 4 days
Blood samples were taken 3 times a day
Time frame: 4 days
Blood samples were taken 3 times a day
Time frame: 4 days
Blood samples were taken 3 times a day
Time frame: 4 days
Blood samples were taken 3 times a day
Time frame: 4 days
Blood samples were taken 3 times a day
Time frame: 4 days
Patients were assessed with to SOWS 4 times a day
Time frame: 4 days
Patients were assessed with to OOWS 4 times a day
Vilnius University
Other
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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