NCT00134914

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 examine the effects of buprenorphine/naloxone when given through different routes and at different doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 1996

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, 1996

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1998

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1998

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
Last Updated

January 12, 2017

Status Verified

July 1, 2008

Enrollment Period

1.7 years

First QC Date

August 23, 2005

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Keywords

opiate dependence

Outcome Measures

Primary Outcomes (3)

  • Opioid agonist rating

    up to one day

  • opiate withdrawal

    up to one day

  • physiologic measures

    up to one day

Interventions

BuprenorphineDRUG

single doses given by sublingual and parenteral routes

Eligibility Criteria

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

You may qualify if:

  • Currently opioid dependent
  • In good health, as determined by a pre-participation medical examination
  • Seeking and eligible for methadone maintenance or detoxification treatment

You may not qualify if:

  • Significant medical or psychiatric illness, other than drug dependence

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)

  • Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology (Berl). 2001 Mar;154(3):230-42. doi: 10.1007/s002130000637.

    PMID: 11351930RESULT

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

  • Eric C. Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

August 1, 1996

Primary Completion

April 1, 1998

Study Completion

May 1, 1998

Last Updated

January 12, 2017

Record last verified: 2008-07

Locations

US(1)