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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02362256 |
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Date of registration:
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18/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
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Scientific title:
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The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02362256 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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JUOZAS IVASKEVICIUS, PROFESSOR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vilnius University Clinic of Anaesthesiology and Intensive Care |
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Name:
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ROBERTAS BADARAS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vilnius University Clinic of Anaesthesiology and Intensive Care |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Opiate Addiction
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Intervention(s)
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Drug: Clonidine
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Drug: Naltrexone
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Drug: Lorazepam
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Primary Outcome(s)
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Adrenocorticotropic hormone (ACTH) levels
[Time Frame: 2 days]
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Cortisol levels
[Time Frame: 2 days]
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Secondary Outcome(s)
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Stress response levels according to blood pressure
[Time Frame: 4 days]
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Changes of sodium concentration due to stress response
[Time Frame: 4 days]
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Objective Opiate Withdrawal Scale (OOWS)
[Time Frame: 4 days]
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Changes of glucose concentration due to stress response
[Time Frame: 4 days]
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Changes of magnesium concentration due to stress response
[Time Frame: 4 days]
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Stress response levels according to respiratory rate
[Time Frame: 4 days]
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Subjective Opiate Withdrawal Scale (SOWS)
[Time Frame: 4 days]
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Changes of chloride concentration due to stress response
[Time Frame: 4 days]
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Changes of potassium concentration due to stress response
[Time Frame: 4 days]
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Stress response levels according to heart rate
[Time Frame: 4 days]
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Secondary ID(s)
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158200-01-443-124
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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