NCT00158236

Brief Summary

Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 1997

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

January 1, 1997

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1998

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2006

First QC Date

September 8, 2005

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Keywords

Opiate AddictionOpiate Dependence

Outcome Measures

Primary Outcomes (2)

  • Opioid agonist effects (measured by Visual Analog Scale and Adjective Rating Scale during the medication challenge sessions)

  • Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the medication challenge sessions)

Interventions

BuprenorphineDRUG
Buprenorphine and NaloxoneDRUG
HydromorphoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Current opioid abuse
  • Not physically dependent on opioids

You may not qualify if:

  • Significant medical or psychiatric illness (e.g., insulin-dependent diabetes or schizophrenia)
  • Seeking substance abuse treatment (will be assisted with referrals to community-based treatment programs)
  • Pregnant

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

Related Publications (1)

  • Strain EC, Stoller K, Walsh SL, Bigelow GE. Effects of buprenorphine versus buprenorphine/naloxone tablets in non-dependent opioid abusers. Psychopharmacology (Berl). 2000 Mar;148(4):374-83. doi: 10.1007/s002130050066.

    PMID: 10928310RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

BuprenorphineBuprenorphine, Naloxone Drug CombinationHydromorphone

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 CompoundsNaloxoneDrug CombinationsPharmaceutical PreparationsMorphine Derivatives

Study Officials

  • Eric C. Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 1997

Study Completion

March 1, 1998

Last Updated

January 12, 2017

Record last verified: 2006-01

Locations

US(1)