Clinical trial NCT02362256: The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
Official title: The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Addiction
Keywords: Opioid detoxification
Opioid antagonist induction
Conscious sedation
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Cortisol levels
timeFrame: 2 days
measure: Adrenocorticotropic hormone (ACTH) levels
timeFrame: 2 days
Secondary outcomes:
measure: Stress response levels according to heart rate
timeFrame: 4 days
measure: Stress response levels according to respiratory rate
timeFrame: 4 days
measure: Stress response levels according to blood pressure
timeFrame: 4 days
measure: Changes of potassium concentration due to stress response
timeFrame: 4 days
measure: Changes of sodium concentration due to stress response
timeFrame: 4 days
measure: Changes of chloride concentration due to stress response
timeFrame: 4 days
measure: Changes of magnesium concentration due to stress response
timeFrame: 4 days
measure: Changes of glucose concentration due to stress response
timeFrame: 4 days
measure: Subjective Opiate Withdrawal Scale (SOWS)
timeFrame: 4 days
measure: Objective Opiate Withdrawal Scale (OOWS)
timeFrame: 4 days
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Republic Vilnius University Hospital
Study officials:
affiliation: Vilnius University Clinic of Anaesthesiology and Intensive Care
name: ROBERTAS BADARAS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vilnius University Clinic of Anaesthesiology and Intensive Care
name: JUOZAS IVASKEVICIUS, PROFESSOR
role: STUDY_DIRECTOR
References: