True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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