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Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia

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: NCT00300794
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : November 14, 2006
Sponsor:
Information provided by:
Vilnius University

Tracking Information
First Submitted Date  ICMJE March 7, 2006
First Posted Date  ICMJE March 9, 2006
Last Update Posted Date November 14, 2006
Study Start Date  ICMJE February 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
Official Title  ICMJE Not Provided
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Opiate Dependence
Intervention  ICMJE Drug: Ketamine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March¬†7,¬†2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300794
Other Study ID Numbers  ICMJE PROT N1 V1_5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Vilnius University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Vilnius University
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP