NCT00000219

Brief Summary

The purpose of this study is to examine the effects in buprenorphine dose alterations in opioid dependent individuals being maintained on buprenorphine.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 1991

Longer than P75 for phase_1

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

December 1, 1991

Completed
7.8 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
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
Last Updated

May 6, 2016

Status Verified

April 1, 1992

First QC Date

September 20, 1999

Last Update Submit

May 5, 2016

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (8)

  • 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: skin temperature

Interventions

BuprenorphineDRUG

Eligibility Criteria

Age19 Years - 41 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Treatment Research Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

  • In preparation. In preparation.

    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
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

December 1, 1991

Study Completion

July 1, 2001

Last Updated

May 6, 2016

Record last verified: 1992-04

Locations

US(1)