- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00300794
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
November 13, 2006 updated by: Vilnius University
The purpose of this study is to determine whether low-dose ketamine infusion is effective in suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).
Study Overview
Study Type
Interventional
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vilnius, Lithuania
- Vilnius University Emergency Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed opiate dependence according to ICD 10 and/or DSM 4;
- Duration of substance abuse more than 1 year
- No or minor co-morbidities;
- Grade I-II according to physical status classification system of American Society of Anesthesiologists.
Exclusion Criteria:
- Current history of long acting opiate or poly-substance abuse;
- Acute medical or surgical condition;
- Pregnancy;
- Breastfeeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Juozas Ivaskevicius, Prof., Vilnius University Clinic of Anaesthesiology and Intensive Care
- Principal Investigator: Tomas Jovaisa, MD, Vilnius University Clinic of Anaesthesiology and Intensive Care
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ivaskevicius J, Jovaisa T, Laurinenas G, Vosylius S, Sipylaite J, Badaras R. [Safety and effectiveness of opiate antagonist detoxification under general anesthesia]. Medicina (Kaunas). 2005;41(12):1011-8. Lithuanian.
- Jovaisa T, Laurinenas G, Vosylius S, Sipylaite J, Badaras R, Ivaskevicius J. Effects of ketamine on precipitated opiate withdrawal. Medicina (Kaunas). 2006;42(8):625-34.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
March 7, 2006
First Submitted That Met QC Criteria
March 7, 2006
First Posted (Estimate)
March 9, 2006
Study Record Updates
Last Update Posted (Estimate)
November 14, 2006
Last Update Submitted That Met QC Criteria
November 13, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- PROT N1 V1_5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.