NCT00000203

Brief Summary

The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence and cocaine abuse.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1988

Longer than P75 for phase_2

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

August 1, 1988

Completed
11.1 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
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

17.8 years

First QC Date

September 20, 1999

Last Update Submit

April 28, 2020

Conditions

Opioid-Related Disorders

Keywords

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (3)

  • Drug use

  • Withdrawal symptoms

  • Psychological symptoms

Interventions

BuprenorphineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

VA Connecticut Healthcare System

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Schottenfeld RS, Pakes J, Ziedonis D, Kosten TR. Buprenorphine: dose-related effects on cocaine and opioid use in cocaine-abusing opioid-dependent humans. Biol Psychiatry. 1993 Jul 1-15;34(1-2):66-74. doi: 10.1016/0006-3223(93)90258-f.

    PMID: 8373940BACKGROUND

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

  • Thomas R Kosten, M.D.

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

August 1, 1988

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

US(1)