Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Phase 4 Terminated 12 enrolled State University of New York at Buffalo

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2007-10
Primary completion: 2008-10
Completion: 2008-10

Outcome

Missed primary endpoint

Stopped: “"Tapering doses" protocol arm was not effective for treatment retention outcome.”

registry Tapering Doses of Buprenorphine vs Steady Dose of Buprenorphine; p = 0.523; Odds Ratio (OR) 0.17 (95% CI 0.0098 to 2.8215); Fisher Exact NCT00552578 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	buprenorphine/naloxone	Unknown	0.5 mg	Other
Subject	buprenorphine/naloxone	Unknown	2 mg	Other