NCT01008072

Brief Summary

The methods of detoxification under general anesthesia have been criticized because of limited data on safety and long-term follow-up. Premedication with buprenorphine has been advocated to improve safety. In current study we want to evaluate the importance of buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

November 5, 2009

Status Verified

November 1, 2009

Enrollment Period

Same day

First QC Date

November 4, 2009

Last Update Submit

November 4, 2009

Conditions

Opioid Addiction

Study Arms (2)

without buprenorphine preparation

with buprenorphine preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All opioid addicted patients who wants to undergo rapid detoxification under general anesthesia.

You may qualify if:

  • Opioid addiction

You may not qualify if:

  • Age \< 18 Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Assaf-Harofeh MC

Beer-Yaakov, Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Murat Bahar, MD

CONTACT

97289778080muratbahar@asaf.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2009

Last Updated

November 5, 2009

Record last verified: 2009-11

Locations

IL(1)