NCT00000224

Brief Summary

The purpose of this study is to evaluate buprenorphine blockade challenge.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1993

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

September 20, 1999

Last Update Submit

June 23, 2005

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (9)

  • Drug use

  • Opioid withdrawal

  • Subjective dose estimate

  • Drug effect characteristics: ARCI

  • Physiological changes in: pupil diameter

  • Physiological changes in: blood pressure

  • Physiological changes in: heart rate

  • Physiological changes in: respiration

  • Physiological changes in: bup plasma levels

Interventions

BuprenorphineDRUG

Eligibility Criteria

Age30 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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Sponsors & Collaborators

Study Sites (1)

Treatment Research Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

  • Bickel, Amass, Badger (in preparation) A double-blind controlled trial of buprenorphine dosing every 72 hours in opioid dependenct humans. Bickel, Amass, Badger (in preparation) A double-blind controlled trial of buprenorphine dosing every 72 hours in opioid dependent humans.

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Warren Bickel, Ph.D.

    University of Vermont

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

February 1, 1993

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(1)