NCT00015171

Brief Summary

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1996

Shorter than P25 for phase_3

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

April 1, 1996

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1997

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1997

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 1999

Enrollment Period

1.1 years

First QC Date

April 18, 2001

Last Update Submit

January 13, 2017

Conditions

Heroin DependenceSubstance-Related Disorders

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (5)

  • Craving

  • Drug use

  • Retention

  • Opioid withdrawal

  • Subjective rating

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

You may not qualify if:

  • Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York MDRU

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Heroin DependenceSubstance-Related DisordersOpioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • John Rotrosen, M.D.

    New York MDRU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

April 1, 1996

Primary Completion

May 1, 1997

Study Completion

June 1, 1997

Last Updated

January 16, 2017

Record last verified: 1999-01

Locations

US(1)