Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia

This study has been completed.

Sponsor:

Information provided by:

Vilnius University

ClinicalTrials.gov Identifier:

NCT00300794

First received: March 7, 2006

Last updated: November 13, 2006

Last verified: November 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2006

Last Updated Date

November 13, 2006

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

Complete list of historical versions of study NCT00300794 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Opiate Dependence

Intervention ^ICMJE

Drug: Ketamine

Study Arm (s)

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

Completion Date

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.

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Lithuania

Administrative Information

NCT Number ^ICMJE

NCT00300794

Other Study ID Numbers ^ICMJE

PROT N1 V1_5

Has Data Monitoring Committee

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

Information Provided By

Vilnius University

Verification Date

November 2006

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

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