NCT02276989|WithdrawnPhase 2DMC
Study Stopped
poor recruitment
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Sponsor study identifier
interventional
0
1 country
1
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this study will investigate the utility and feasibility of two novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor adherence to study drug prescription in the parent clinical trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2014
Actual (reported)October 28, 2014
Actual (reported)December 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)January 2016
Actual (reported)Pharmacokinetic profiles for each medication/tracer (assayed from blood and urine samples) and will include parameters such as AUC, CMAX, TMax, and t1/2.
26 days
Subjects will receive acetazolamide, quinine and riboflavin as experimental compliance markers and will serve as their own controls.
On evening of Day 0, subjects will arrive at the session previously stabilized on buprenorphine and pregabalin. Pregabalin titration = 6 days prior to Day 0, during which time they will receive 100mg/day x 2 days, 200mg/day x2 days, and 300mg/day x 2 days, with the subjects receiving the full dose of 400mg/day beginning Day 0. On Day 1, pregabalin PK measures will be collected. On the mornings (8am) of Days 1 - 5, PGB compounded with the first tracer, ACZ will be administered. On Day 5, subjects will again undergo PK testing on PGB + ACZ tracer. On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected. On the mornings of Days 7-8 subjects will receive their PGB dose only.
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Peggy Compton, RN, PhD
Georgetown University
0 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2014
First Posted
October 28, 2014
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Sublingual Buprenorphine for Chronic Pain
On the morning of Days 8-11, subjects will be administered the same dose of PGB, now compounded with the QUIN. On Day 11, PK testing of QUIN and PGB will be repeated. On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected. On Day 13 patients will be discharged with take-home doses of PGB that will taper to zero over the period of one week.
All subjects will receive riboflavin on the following days of the study: On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected. On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected.
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Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
February 10, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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