Back to resultsEffects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
Primary Purpose
Opiate Dependence
Status
Completed
Phase
Phase 4
Locations
Lithuania
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence
Eligibility Criteria
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.
Sites / Locations
- Vilnius University Emergency Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00300794
Brief Title
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vilnius University
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ketamine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juozas Ivaskevicius, Prof.
Organizational Affiliation
Vilnius University Clinic of Anaesthesiology and Intensive Care
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tomas Jovaisa, MD
Organizational Affiliation
Vilnius University Clinic of Anaesthesiology and Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University Emergency Hospital
City
Vilnius
Country
Lithuania
12. IPD Sharing Statement
Citations:
PubMed Identifier
16401957
Citation
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.
Results Reference
result
PubMed Identifier
16963828
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
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