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

NCT ID: NCT02362256

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-09-30

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).

Conditions

Opiate Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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)

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Clonidine

Intervention Type: DRUG

Lorazepam

Intervention Type: DRUG

Control

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)

Group Type: ACTIVE_COMPARATOR

Naltrexone

Intervention Type: DRUG

Clonidine

Intervention Type: DRUG

Lorazepam

Intervention Type: DRUG

Interventions

Naltrexone

Intervention Type: DRUG

Clonidine

Intervention Type: DRUG

Lorazepam

Intervention Type: DRUG

Other Intervention Names

Vivitrol; Revia; Catapres; Kapvay; Ativan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Robertas Badaras

MD Robertas Badaras

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ROBERTAS BADARAS, MD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University Clinic of Anaesthesiology and Intensive Care

JUOZAS IVASKEVICIUS, PROFESSOR

Role: STUDY_DIRECTOR

Vilnius University Clinic of Anaesthesiology and Intensive Care

Locations

Republic Vilnius University Hospital

Vilnius, Vilnius County, Lithuania

Countries

Lithuania

Other Identifiers

158200-01-443-124

Identifier Type: -

Identifier Source: org_study_id