Study Stopped
"Tapering doses" protocol arm was not effective for treatment retention outcome.
Buprenorphine as a Treatment in Opiate Dependent Pain Patients
A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients
1 other identifier
interventional
12
1 country
1
Brief Summary
This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2007
Shorter than P25 for phase_4
1 active site
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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 1, 2007
CompletedFirst Posted
Study publicly available on registry
November 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 7, 2009
CompletedFebruary 17, 2011
February 1, 2011
1 year
November 1, 2007
January 21, 2009
February 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse to Substance Abuse
Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.
Six months
Secondary Outcomes (2)
Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.
Baseline and six months
Treatment Retention.
Six months
Study Arms (2)
Tapering doses of buprenorphine
ACTIVE COMPARATORParticipants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Steady doses of buprenrophine
EXPERIMENTALParticipants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Interventions
sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response)
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of chronic refractory pain
- Clinical diagnosis of opiate dependency
You may not qualify if:
- unable to pay for medication
- enrolled in a methadone maintenance program
- homelessness
- major mental illness
- pregnant women
- prisoners
- terminal cancer pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erie County Medical Center
Buffalo, New York, 14215, United States
Related Publications (1)
Blondell RD, Ashrafioun L, Dambra CM, Foschio EM, Zielinski AL, Salcedo DM. A Clinical Trial Comparing Tapering Doses of Buprenorphine with Steady Doses for Chronic Pain and Co-existent Opioid Addiction. J Addict Med. 2010 Sep;4(3):140-6. doi: 10.1097/ADM.0b013e3181ba895d.
PMID: 20959867RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- R Blondell
- Organization
- SUNY Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Blondell, MD
University at Buffalo
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 2007
First Posted
November 2, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
February 17, 2011
Results First Posted
July 7, 2009
Record last verified: 2011-02