Opiate DependencePhase 4NCT00300794
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
A Phase 4 study testing Ketamine in people with Opiate Dependence, run by Vilnius University at 1 site in Lithuania.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Ketamine
- How many people
- 60 participants
- Where
- 1 siteLithuania
- Study dates
- Feb 2003to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Current history of long acting opiate or poly-substance abuse;
- Acute medical or surgical condition;
- Pregnancy;
- Breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Opiate Dependence
- Being tested
- Ketamine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startFeb 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Investigators
- Juozas Ivaskevicius, Prof., Study director, Vilnius University Clinic of Anaesthesiology and Intensive CareTomas Jovaisa, MD, Principal investigator, Vilnius University Clinic of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300794
- Sponsor's protocol ID
- PROT N1 V1_5
- Status last verified
- Nov 2006
- First submitted
- 7 Mar 2006
- Last updated
- 14 Nov 2006
- Results posted
- No
Publications
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.
PubMed 16401957Jovaisa 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.
PubMed 16963828
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT00300794
- Acronym / sponsor ID
- PROT N1 V1_5
- Conditions
- Opiate Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Jun 2006
- First posted
- 9 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Current history of long acting opiate or poly-substance abuse;
- Acute medical or surgical condition;
- Pregnancy;
- Breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2006.
- Results publication: PubMed 16401957Ivaskevicius 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 publication: PubMed 16963828Jovaisa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juozas Ivaskevicius, Prof. study director
Vilnius University Clinic of Anaesthesiology and Intensive Care
Tomas Jovaisa, MD principal investigator
Vilnius University Clinic of Anaesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Opiate Dependence, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300794, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2006.