NCT00149539

Brief Summary

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

July 1, 2007

First QC Date

September 6, 2005

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (3)

  • Opiate withdrawal

    up to one day

  • opiate agonist symptoms

    up to one day

  • physiologic measures

    up to one day

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Actively abusing illegal opioids
  • Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry
  • Meets DSM-IV criteria for opioid dependence

You may not qualify if:

  • Significant medical problems (e.g., insulin dependent diabetes mellitus)
  • Non-substance use psychiatric disorders (e.g., schizophrenia)
  • Seeking substance abuse treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224 6823, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-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

  • Eric C. Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2004

Study Completion

January 1, 2006

Last Updated

January 12, 2017

Record last verified: 2007-07

Locations

US(1)