NCT00347815

Brief Summary

The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1 healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

July 4, 2006

Status Verified

June 1, 2006

First QC Date

July 3, 2006

Last Update Submit

July 3, 2006

Conditions

Healthy Volunteers

Interventions

BuprenorphineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy 18-40 years able to follow the protocol able to provide informed consent

You may not qualify if:

  • Allergy to buprenorphine
  • Mental illness
  • Alcohol or drug abuse
  • Chronic pain
  • Daily use of analgesics
  • Chronic medicinal treatment
  • Treatment with corticosteroids
  • Any use of medicine 48 hours before day of trial
  • Smoker
  • Blood donation within 3 months before day of trial
  • Dementia
  • Abnormal ECG
  • Abnormal blood values:
  • Serum creatinine \> 100 umol/l Serum haemoglobin \< 8 mmol/L LDH \< 105 U/L or \> 255 U/L ASAT \> 45 U/L ALAT \> 70 U/L PP \< 0.9 INR or \> 1.1 INR Alkaline phosphatase \< 35 U/L or \> 275 U/L K+ \< 3,5 mmol/L or \> 5,0 mmol/L Na + \< 136 mmol/L or \> 146 mmol/

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte University Hospital

Hellerup, DK-2900, Denmark

RECRUITING

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Niels-Henrik Jensen, MD

    Multidisciplinary Pain Centre, Herlev Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels-Henrik Jensen, MD

CONTACT

004544884623nije@herlevhosp.kbhamt.dk

Mette L Jensen, M Sc pharm

CONTACT

004561676954mlj@dfuni.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Study Completion

August 1, 2006

Last Updated

July 4, 2006

Record last verified: 2006-06

Locations

DK(1)