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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00300794
Other study ID # PROT N1 V1_5
Secondary ID
Status Completed
Phase Phase 4
First received March 7, 2006
Last updated November 13, 2006
Start date February 2003
Est. completion date June 2006

Study information

Verified date November 2006
Source Vilnius University
Contact n/a
Is FDA regulated No
Health authority Lithuania: State Medicine Control Agency - Ministry of Health
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine


Locations

Country Name City State
Lithuania Vilnius University Emergency Hospital Vilnius

Sponsors (1)

Lead Sponsor Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

References & Publications (2)

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. — View 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. — View Citation

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