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

NCT02362256 | Completed

• 1 other identifier: 158200-01-443-124
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Addiction

Keywords

Opioid detoxification; Opioid antagonist induction; Conscious sedation

Outcome Measures

Primary Outcomes (2)

• Cortisol levels

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

  2 days

• 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)

  2 days

Secondary Outcomes (10)

• Stress response levels according to heart rate

  4 days

• Stress response levels according to respiratory rate

  4 days

• Stress response levels according to blood pressure

  4 days

• Changes of potassium concentration due to stress response

  4 days

• Changes of sodium concentration due to stress response

  4 days

Study Arms (2)

Intervention

EXPERIMENTAL

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: 1. st hour 50 µg 2. nd hour 50 µg 3. rd hour 100 µg 4. th hour 100 µg 5. th hour 200 µg 6. th hour 400 µg 7. th hour 800 µg 8. th hour 1600 µg 9. th hour 3200 µg 10. 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)

Drug: Naltrexone; Drug: Clonidine; Drug: Lorazepam

Control

ACTIVE COMPARATOR

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)

Drug: Naltrexone; Drug: Clonidine; Drug: Lorazepam

Interventions

Naltrexone DRUG

Also known as: Vivitrol, Revia

Control; Intervention

Clonidine DRUG

Also known as: Catapres, Kapvay

Control; Intervention

Lorazepam DRUG

Also known as: Ativan

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Republic Vilnius University Hospital

Vilnius, Vilnius County, LT-04130, Lithuania

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone; vivitrol; Clonidine; Lorazepam

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Officials

• ROBERTAS BADARAS, MD

  Vilnius University Clinic of Anaesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

• JUOZAS IVASKEVICIUS, PROFESSOR

  Vilnius University Clinic of Anaesthesiology and Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Robertas Badaras

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: February 12, 2015
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

LI (1)