True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Unknown statusPhase 4NCT05419297
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective, Double Blind, Placebo-controlled Study of Buccal Buprenorphine
- Conditions
- Interventions
- Drug: Buprenorphine Buccal Film [Belbuca]
- Other: Urine Drug Screening
- Device: actigraph
- Behavioral: PROMIS 29
- Other: sit to stand test
- Other: numerical rating scale pain score
- Behavioral: patient global impression of function
- Behavioral: PROMIS - sleep
- Sponsor
- Carolinas Pain Institute
- Collaborators
- BioDelivery Sciences International
- Start date
- 2022-08-03
- Primary completion
- 2023-07
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Meets our criteria for CNRBP: * Pain of 3 months or more duration * non-radiating (below buttocks or above lower back pain) * no decreased sensation or allodynia/hyperalgesia in a radicular pattern * no reflex asymmetry * no frank weakness or atrophy * no non-pain sensory or reflex changes 2. If female, not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl). 3. Able to read and speak English and provide informed consent. 4. Age 18-65. 5. 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). 6. Subjects may continue any non-opioid stable scheduled drug regimen with no changes during the course of study, hydrocodone/acetaminophen 5/325 up to two doses per day along with Tylenol 2g/day are the only allowed rescue medications. Subjects are asked not to use the rescue medication 12 hours or less before testing. 7. Subjects taking opioids must agree to 'detoxify' for the protocol under the supervision of the study medical personnel. Subjects may use hydrocodone/acetaminophen 5/325 twice daily for breakthrough pain, as provided to them during the study, and must use only the hydrocodone/acetaminophen provided (with a pill count is a secondary outcome) 8. Subjects must agree to try to stay as functional as possible (defined by only tolerable increase in pain with function or function testing) 9. Must have 'average' pain greater than or equal to 4 and no greater that 9 on a 10-point NRS scale at phone screening and first visit 10. Subjects must have and maintain a working phone 11. CMP, CBC, UDS, EKG within normal limits at the discretion of the PI. \- Exclusion Criteria: 1. Subjects with hypersensitivity to Opioids, Acetaminophen, buprenorphine or Belbuca® 2. Subjects taking equal to or more than 100 morphine milliequivalents, 3. Subjects with severe or untreated psychiatric disturbance (e.g. mania, depression \[esp suicidality\], anxiety, substance use disorder etc). This exclusion at the discretion of the PI. 4. A known or admitted history of opioid abuse, diversion or addiction. 5. Subjects with severe, ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease i. \[creatinine\>1.5 ml/dl; AST or ALT\> 2x normal limit\], severe or uncontrolled hypertension, pulmonary ii. disease, se…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05419297