NCT00218101

Brief Summary

Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

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 phase_2

Timeline
Completed

Started May 2004

Shorter than P25 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

May 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

First QC Date

September 16, 2005

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (3)

  • Substance use

  • medication compliance

  • treatment retention

Secondary Outcomes (1)

  • Behavioral and psychological measures (measured during the dose reduction phase)

Interventions

BuprenorphineDRUG

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current opioid analgesic dependence
  • History of at least 2 years of oral opiate analgesic use
  • Prescribed opioids for chronic pain
  • Pain episode of at least 6 months duration within the 5 years prior to study entry
  • Available for the duration of the study
  • Good general health

You may not qualify if:

  • Currently using any illicit substance
  • Meets criteria for alcohol dependence
  • History of heroin use
  • History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone
  • Evidence of current maximal primary pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

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

  • John Grabowski, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

May 1, 2004

Study Completion

March 1, 2005

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)