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

Opiate Addiction Clinical Trial

Official title:

The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362256
• Other study ID #: 158200-01-443-124
• Status: Completed
• Phase: N/A
• First received: January 18, 2015
• Last updated: February 11, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Addiction

Intervention

Drug:
• Naltrexone

• Clonidine

• Lorazepam

Locations

Country	Name	City	State
Lithuania	Republic Vilnius University Hospital	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Stress response levels according to heart rate	Heart rate measurements were taken 4 times a day	4 days	No
Secondary	Stress response levels according to respiratory rate	Respiratory rate measurements were taken 4 times a day	4 days	No
Secondary	Stress response levels according to blood pressure	Blood pressure measurements were taken 4 times a day	4 days	No
Secondary	Changes of potassium concentration due to stress response	Blood samples were taken 3 times a day	4 days	No
Secondary	Changes of sodium concentration due to stress response	Blood samples were taken 3 times a day	4 days	No
Secondary	Changes of chloride concentration due to stress response	Blood samples were taken 3 times a day	4 days	No
Secondary	Changes of magnesium concentration due to stress response	Blood samples were taken 3 times a day	4 days	No
Secondary	Changes of glucose concentration due to stress response	Blood samples were taken 3 times a day	4 days	No
Secondary	Subjective Opiate Withdrawal Scale (SOWS)	Patients were assessed with to SOWS 4 times a day	4 days	No
Secondary	Objective Opiate Withdrawal Scale (OOWS)	Patients were assessed with to OOWS 4 times a day	4 days	No

External Links

•   Intermediate data