NCT00300794

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 14, 2006

Status Verified

November 1, 2006

First QC Date

March 7, 2006

Last Update Submit

November 13, 2006

Conditions

Opiate Dependence

Interventions

KetamineDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Current history of long acting opiate or poly-substance abuse;
  • Acute medical or surgical condition;
  • Pregnancy;
  • Breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Emergency Hospital

Vilnius, Lithuania

Location

Related 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.

    PMID: 16401957RESULT

  • 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.

    PMID: 16963828RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Juozas Ivaskevicius, Prof.

    Vilnius University Clinic of Anaesthesiology and Intensive Care

    STUDY DIRECTOR

  • Tomas Jovaisa, MD

    Vilnius University Clinic of Anaesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

February 1, 2003

Study Completion

June 1, 2006

Last Updated

November 14, 2006

Record last verified: 2006-11

Locations

LI(1)