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What conditions do you have?
What conditions do you have?
To study the response of objective and quasi-objective 'True' functional outcomes, analgesia and safety in chronic non-radicular back pain to buprenorphine buccal film (BBF) using a small 'n' phase IV design. To assess associations between traditional pain relevant subjective outcomes and objective or quasi-objective functional outcomes; In a small 'n' construct, to assess more powerful, 'new' statistical methods (e.g. hierarchical linear models, joint trajectory analysis) compared to traditional methods, in the context of increased power, more objective outcomes and cost savings.
First a 2-week washout of any opioid medication (if necessary; if not necessary subject can proceed directly to); baseline week (Single Blind Placebo Lead In (SBPLI), using the placebo film resembling the 150mcg dose; then randomization to a ~ 2 week up titration either to effective Buprenorphine Buccal Film (BBF) dose 2 day average pain better than or equal to 3/10 NRS), highest tolerated dose BBF and/or maximum dose BBF of 900 mcg BID, or identical placebo material up to these parameters. This up titration is at the discretion and timing of the blinded and experienced PI. Subject will be allowed two doses of hydrocodone/acetaminophen 5/325 daily during the washout period.
A single experienced practitioner will manage the titration as to safety, detail and timing; and determine when the subject enters the 8 week stable dose trial; this practitioner will remain blinded throughout unless there is an urgent, safety reason for unblinding
Primary Treatment: Active drug arm · Has Placebo Group · Phase 4
Active drug armActiveComparator Group · 8 Interventions: Buprenorphine Buccal Film [Belbuca], Urine Drug Screening, PROMIS 29, patient global impression of function, actigraph, sit to stand test, PROMIS - sleep, numerical rating scale pain score · Intervention Types: Drug, Other, Behavioral, Behavioral, Device, Other, Behavioral, Other
Placebo armPlaceboComparator Group · 7 Interventions: Urine Drug Screening, PROMIS 29, patient global impression of function, actigraph, sit to stand test, PROMIS - sleep, numerical rating scale pain score · Intervention Types: Other, Behavioral, Behavioral, Device, Other, Behavioral, Other
Screening: ~3 weeks
Reporting: 20 weeks
Closest Location: Carolinas Pain Institute · Winston-Salem, NC
2009First Recorded Clinical Trial
1 TrialsResearching Chronic Pain
3 CompletedClinical Trials
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:
You are able to understand and comply with all data collection methodology, and demonstrated ability to manage the electronic diary system (as tested in 'detox' and baseline/SBPLI period).
You have a pain that is not radiating.
You are not pregnant or breast feeding, and you are not currently attempting to conceive
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.