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The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

Primary Purpose

Opiate Addiction

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Naltrexone
Clonidine
Lorazepam
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring Opioid detoxification, Opioid antagonist induction, Conscious sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Republic Vilnius University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol: st hour 50 µg nd hour 50 µg rd hour 100 µg th hour 100 µg th hour 200 µg th hour 400 µg th hour 800 µg th hour 1600 µg th hour 3200 µg th hour 6000 µg Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)

Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)

Outcomes

Primary Outcome Measures

Cortisol levels
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
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)

Secondary Outcome Measures

Stress response levels according to heart rate
Heart rate measurements were taken 4 times a day
Stress response levels according to respiratory rate
Respiratory rate measurements were taken 4 times a day
Stress response levels according to blood pressure
Blood pressure measurements were taken 4 times a day
Changes of potassium concentration due to stress response
Blood samples were taken 3 times a day
Changes of sodium concentration due to stress response
Blood samples were taken 3 times a day
Changes of chloride concentration due to stress response
Blood samples were taken 3 times a day
Changes of magnesium concentration due to stress response
Blood samples were taken 3 times a day
Changes of glucose concentration due to stress response
Blood samples were taken 3 times a day
Subjective Opiate Withdrawal Scale (SOWS)
Patients were assessed with to SOWS 4 times a day
Objective Opiate Withdrawal Scale (OOWS)
Patients were assessed with to OOWS 4 times a day

Full Information

First Posted
January 18, 2015
Last Updated
February 11, 2015
Sponsor
Vilnius University
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1. Study Identification

Unique Protocol Identification Number
NCT02362256
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
Opioid detoxification, Opioid antagonist induction, Conscious sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol: st hour 50 µg nd hour 50 µg rd hour 100 µg th hour 100 µg th hour 200 µg th hour 400 µg th hour 800 µg th hour 1600 µg th hour 3200 µg th hour 6000 µg Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Vivitrol, Revia
Intervention Type
Drug
Intervention Name(s)
Clonidine
Other Intervention Name(s)
Catapres, Kapvay
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Ativan
Primary Outcome Measure Information:
Title
Cortisol levels
Description
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
Title
Adrenocorticotropic hormone (ACTH) levels
Description
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
Secondary Outcome Measure Information:
Title
Stress response levels according to heart rate
Description
Heart rate measurements were taken 4 times a day
Time Frame
4 days
Title
Stress response levels according to respiratory rate
Description
Respiratory rate measurements were taken 4 times a day
Time Frame
4 days
Title
Stress response levels according to blood pressure
Description
Blood pressure measurements were taken 4 times a day
Time Frame
4 days
Title
Changes of potassium concentration due to stress response
Description
Blood samples were taken 3 times a day
Time Frame
4 days
Title
Changes of sodium concentration due to stress response
Description
Blood samples were taken 3 times a day
Time Frame
4 days
Title
Changes of chloride concentration due to stress response
Description
Blood samples were taken 3 times a day
Time Frame
4 days
Title
Changes of magnesium concentration due to stress response
Description
Blood samples were taken 3 times a day
Time Frame
4 days
Title
Changes of glucose concentration due to stress response
Description
Blood samples were taken 3 times a day
Time Frame
4 days
Title
Subjective Opiate Withdrawal Scale (SOWS)
Description
Patients were assessed with to SOWS 4 times a day
Time Frame
4 days
Title
Objective Opiate Withdrawal Scale (OOWS)
Description
Patients were assessed with to OOWS 4 times a day
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROBERTAS BADARAS, MD
Organizational Affiliation
Vilnius University Clinic of Anaesthesiology and Intensive Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JUOZAS IVASKEVICIUS, PROFESSOR
Organizational Affiliation
Vilnius University Clinic of Anaesthesiology and Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Republic Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania

12. IPD Sharing Statement

Links:
URL
http://alcalc.oxfordjournals.org/content/49/suppl_1/i47.2
Description
Intermediate data

Learn more about this trial

The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

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