Active drug arm for Chronic Pain

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Carolinas Pain Institute, Winston-Salem, NC
Chronic Pain+3 More
Buprenorphine Buccal Film [Belbuca] - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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

Eligible Conditions

  • Chronic Pain
  • Chronic Lower Back Pain (CLBP)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

9 Primary · 4 Secondary · Reporting Duration: 20 weeks

20 weeks
Activity
Activity - steps per day
Activity - time sitting
Bayesian analysis
Function
Numberic Rating Scale
Patient Reported Outcomes Information System - 29
Patient Reported Outcomes Information System - Sleep
Patient global impression of function
Sit to stand test
Sleep
Timed stair climb
activity -sleep

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Active drug arm
1 of 2
Placebo arm
1 of 2
Active Control
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 weeks
Closest Location: Carolinas Pain Institute · Winston-Salem, NC
2009First Recorded Clinical Trial
1 TrialsResearching Chronic Pain
3 CompletedClinical Trials

Eligibility Criteria

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

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.