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Completed

NCT Number: NCT02362256

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Republic Vilnius University Hospital

Vilnius, Vilnius County, LT-04130, Lithuania

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

Other names: Vivitrol, Revia

Clonidine

Drug

Other names: Catapres, Kapvay

Lorazepam

Drug

Other names: Ativan

Primary outcomes

  1. Cortisol levels

    Time frame: 2 days

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

  2. Adrenocorticotropic hormone (ACTH) levels

    Time frame: 2 days

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

Secondary outcomes

  1. Stress response levels according to heart rate

    Time frame: 4 days

    Heart rate measurements were taken 4 times a day

  2. Stress response levels according to respiratory rate

    Time frame: 4 days

    Respiratory rate measurements were taken 4 times a day

  3. Stress response levels according to blood pressure

    Time frame: 4 days

    Blood pressure measurements were taken 4 times a day

  4. Changes of potassium concentration due to stress response

    Time frame: 4 days

    Blood samples were taken 3 times a day

  5. Changes of sodium concentration due to stress response

    Time frame: 4 days

    Blood samples were taken 3 times a day

  6. Changes of chloride concentration due to stress response

    Time frame: 4 days

    Blood samples were taken 3 times a day

  7. Changes of magnesium concentration due to stress response

    Time frame: 4 days

    Blood samples were taken 3 times a day

  8. Changes of glucose concentration due to stress response

    Time frame: 4 days

    Blood samples were taken 3 times a day

  9. Subjective Opiate Withdrawal Scale (SOWS)

    Time frame: 4 days

    Patients were assessed with to SOWS 4 times a day

  10. Objective Opiate Withdrawal Scale (OOWS)

    Time frame: 4 days

    Patients were assessed with to OOWS 4 times a day

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2015
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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