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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362256
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Robertas Badaras, Vilnius University

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.

Condition or disease Intervention/treatment Phase
Opiate Addiction Drug: Naltrexone Drug: Clonidine Drug: Lorazepam Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)

Drug: Naltrexone
Other Names:
  • Vivitrol
  • Revia

Drug: Clonidine
Other Names:
  • Catapres
  • Kapvay

Drug: Lorazepam
Other Name: Ativan

Active Comparator: 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)

Drug: Naltrexone
Other Names:
  • Vivitrol
  • Revia

Drug: Clonidine
Other Names:
  • Catapres
  • Kapvay

Drug: Lorazepam
Other Name: Ativan




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362256


Locations
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Lithuania
Republic Vilnius University Hospital
Vilnius, Lithuania, LT-04130
Sponsors and Collaborators
Vilnius University
Investigators
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Principal Investigator: ROBERTAS BADARAS, MD Vilnius University Clinic of Anaesthesiology and Intensive Care
Study Director: JUOZAS IVASKEVICIUS, PROFESSOR Vilnius University Clinic of Anaesthesiology and Intensive Care
Additional Information:
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Responsible Party: Robertas Badaras, MD Robertas Badaras, Vilnius University
ClinicalTrials.gov Identifier: NCT02362256    
Other Study ID Numbers: 158200-01-443-124
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Keywords provided by Robertas Badaras, Vilnius University:
Opioid detoxification
Opioid antagonist induction
Conscious sedation
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Clonidine
Naltrexone
Lorazepam
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Antiemetics
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs