The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
Information source: Vilnius University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Addiction
Intervention: Naltrexone (Drug); Clonidine (Drug); Lorazepam (Drug)
Phase: N/A
Status: Completed
Sponsored by: Vilnius University Official(s) and/or principal investigator(s): ROBERTAS BADARAS, MD, Principal Investigator, Affiliation: Vilnius University Clinic of Anaesthesiology and Intensive Care JUOZAS IVASKEVICIUS, PROFESSOR, Study Director, Affiliation: Vilnius University Clinic of Anaesthesiology and Intensive Care
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.
Clinical Details
Official title: The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cortisol levelsAdrenocorticotropic hormone (ACTH) levels
Secondary outcome: Stress response levels according to heart rateStress response levels according to respiratory rate Stress response levels according to blood pressure Changes of potassium concentration due to stress response Changes of sodium concentration due to stress response Changes of chloride concentration due to stress response Changes of magnesium concentration due to stress response Changes of glucose concentration due to stress response Subjective Opiate Withdrawal Scale (SOWS) Objective Opiate Withdrawal Scale (OOWS)
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Republic Vilnius University Hospital, Vilnius LT-04130, Lithuania
Additional Information
Intermediate data
Starting date: May 2014
Last updated: February 11, 2015
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